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Trial record 8 of 10 for:    Oocyte Maturation Defect 2

Corifollitropin Alfa in Participants Undergoing Repeated Controlled Ovarian Stimulation (COS) Cycles Using a Multiple Dose Gonadatropin Releasing Hormone (GnRH) Antagonist Protocol (Study 38825)(P05714) (Trust)

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ClinicalTrials.gov Identifier: NCT00696878
Recruitment Status : Completed
First Posted : June 13, 2008
Results First Posted : April 23, 2015
Last Update Posted : September 3, 2018
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition In Vitro Fertilization
Interventions Drug: Corifollitropin alfa
Biological: FSH
Biological: GnRH antagonist
Biological: (rec)hCG
Drug: Progesterone
Enrollment 682
Recruitment Details  
Pre-assignment Details To complete study, a participant must have embryo transfer in the 3rd Controlled Ovarian Stimulation (COS) cycle (Treatment Cycle 3).
Arm/Group Title Corifollitropin Alfa 150 µg
Hide Arm/Group Description Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of Gonadotropin Releasing Hormone (GnRH) antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of recombinant Human Chorion Gonadotropin ([rec]hCG) (5,000-10,000 IU/250 µg). Daily dosing with Follicle Stimulating Hormone (FSH) (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, Frozen-Thawed Embryo Transfer (FTET) cycles (up to 3 after each COS cycle) could occur.
Period Title: Overall Study
Started 682
Completed 178
Not Completed 504
Reason Not Completed
Adverse Event             8
Withdrawal by Subject             87
Stop Treat Cycle 3 not for Adverse Event             18
Pregnant prior to Treat Cycle 3             304
Trial stopped             32
Other reason (not specified)             55
Arm/Group Title Corifollitropin Alfa 150 µg
Hide Arm/Group Description Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
Overall Number of Baseline Participants 682
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 682 participants
32.9  (3.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 682 participants
Female
682
 100.0%
Male
0
   0.0%
1.Primary Outcome
Title Percentage of Participants With Clinically Relevant Immunogenicity
Hide Description Serum samples obtained pre-dose and at 2 weeks after embryo transfer (ET), or at cycle discontinuation and 2-3 weeks after cycle discontinuation if cycle was stopped before ET was performed, were analyzed for presence of anti-corifollitropin alfa antibodies using screening and confirmatory tests. If a participant was confirmed to have anti-corifollitropin alfa antibody present in a post dose sample according to these tests, review of adverse events (AEs) in the participant was performed. The sample was also tested to evaluate whether the antibody appeared to have neutralizing activity that would interfere with the study drug biological effect. A participant was determined to have clinically relevant immunogenicity if the participant had a confirmed post dose anti-corifollitropin alfa antibody test result accompanied by clinical signs of immunogenicity (e.g., hypersensitivity reaction), considering also the results of the test for neutralizing activity of any antibody present.
Time Frame Pre-dose (Stimulation Day 1) and up to approximately 40 days post dose in each treatment cycle
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received corifollitropin alfa and had a post dose sample for anti-corifollitropin alfa antibody testing
Arm/Group Title Corifollitropin Alfa 150 µg
Hide Arm/Group Description:
Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
Overall Number of Participants Analyzed 682
Measure Type: Number
Unit of Measure: percentage of participants
Cycle 1 (n=681) 0.0
Cycle 2 (n=372) 0.0
Cycle 3 (n=192) 0.0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Corifollitropin Alfa 150 µg
Comments During sample size determination, the upper limit of the one-sided 95% confidence interval for the population incidence of immunogenicity, if no immunogenicity is observed, was calculated. If no immunogenicity is observed in the projected 150 participants who receive corifollitropin alfa during 3 COS cycles, then the upper limit for the population is 2%. For the projected 300 participants who receive corifollitropin alfa during 2 COS cycles, the upper limit for the population is 1%.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage with immunogenicity
Estimated Value 0.0
Confidence Interval (1-Sided) 95%
0.4
Estimation Comments Provided limit is upper 1-sided 95% confidence limit for study population for percentage of participants with clinically relevant immunogenicity, after Cycle 1
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Corifollitropin Alfa 150 µg
Comments During sample size determination, the upper limit of the one-sided 95% confidence interval for the population incidence of immunogenicity, if no immunogenicity is observed, was calculated. If no immunogenicity is observed in the projected 150 participants who receive corifollitropin alfa during 3 COS cycles, then the upper limit for the population is 2%. For the projected 300 participants who receive corifollitropin alfa during 2 COS cycles, the upper limit for the population is 1%.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage with immunogenicity
Estimated Value 0.0
Confidence Interval (1-Sided) 95%
0.8
Estimation Comments Provided limit is upper 1-sided 95% confidence limit for study population for percentage of participants with clinically relevant immunogenicity, after Cycle 2
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Corifollitropin Alfa 150 µg
Comments During sample size determination, the upper limit of the one-sided 95% confidence interval for the population incidence of immunogenicity, if no immunogenicity is observed, was calculated. If no immunogenicity is observed in the projected 150 participants who receive corifollitropin alfa during 3 COS cycles, then the upper limit for the population is 2%. For the projected 300 participants who receive corifollitropin alfa during 2 COS cycles, the upper limit for the population is 1%.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage with immunogenicity
Estimated Value 0.0
Confidence Interval (1-Sided) 95%
1.5
Estimation Comments Provided limit is upper 1-sided 95% confidence limit for study population for percentage of participants with clinically relevant immunogenicity, after Cycle 3
2.Primary Outcome
Title Local Tolerance at Injection Site: Number of Participants With no Event of Itching and With Mild, Moderate and Severe Itching in Any of 3 Treatment Cycles
Hide Description At 30 minutes after dosing in each treatment cycle, the corifollitropin alfa injection site was assessed for the presence of itching, pain, redness and swelling, each of which was scored as none (no event), mild, moderate or severe. This measure reports results for the assessment of itching. A participant with an event was counted once in this analysis.
Time Frame 30 minutes post dose in each treatment cycle
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received corifollitropin alfa
Arm/Group Title Corifollitropin Alfa 150 µg
Hide Arm/Group Description:
Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
Overall Number of Participants Analyzed 682
Measure Type: Number
Unit of Measure: participants
None 679
Mild 3
Moderate 0
Severe 0
3.Primary Outcome
Title Local Tolerance at Injection Site: Number of Participants With no Event of Pain and With Mild, Moderate and Severe Pain in Any of 3 Treatment Cycles
Hide Description At 30 minutes after dosing in each treatment cycle, the corifollitropin alfa injection site was assessed for the presence of itching, pain, redness and swelling, each of which was scored as none (no event), mild, moderate or severe. This measure reports results for the assessment of pain. A participant with an event was counted once in this analysis.
Time Frame 30 minutes post dose in each treatment cycle
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received corifollitropin alfa
Arm/Group Title Corifollitropin Alfa 150 µg
Hide Arm/Group Description:
Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
Overall Number of Participants Analyzed 682
Measure Type: Number
Unit of Measure: participants
None 678
Mild 4
Moderate 0
Severe 0
4.Primary Outcome
Title Local Tolerance at Injection Site: Number of Participants With no Event of Redness and With Mild, Moderate and Severe Redness in Any of 3 Treatment Cycles
Hide Description At 30 minutes after dosing in each treatment cycle, the corifollitropin alfa injection site was assessed for the presence of itching, pain, redness and swelling, each of which was scored as none (no event), mild, moderate or severe. This measure reports results for the assessment of redness. A participant with an event was counted once in this analysis.
Time Frame 30 minutes post dose in each treatment cycle
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received corifollitropin alfa
Arm/Group Title Corifollitropin Alfa 150 µg
Hide Arm/Group Description:
Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
Overall Number of Participants Analyzed 682
Measure Type: Number
Unit of Measure: participants
None 654
Mild 28
Moderate 0
Severe 0
5.Primary Outcome
Title Local Tolerance at Injection Site: Number of Participants With no Event of Swelling and With Mild, Moderate and Severe Swelling in Any of 3 Treatment Cycles
Hide Description At 30 minutes after dosing in each treatment cycle, the corifollitropin alfa injection site was assessed for the presence of itching, pain, redness and swelling, each of which was scored as none (no event), mild, moderate or severe. This measure reports results for the assessment of swelling. A participant with an event was counted once in this analysis.
Time Frame 30 minutes post dose in each treatment cycle
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received corifollitropin alfa
Arm/Group Title Corifollitropin Alfa 150 µg
Hide Arm/Group Description:
Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
Overall Number of Participants Analyzed 682
Measure Type: Number
Unit of Measure: participants
None 680
Mild 2
Moderate 0
Severe 0
6.Primary Outcome
Title Local Tolerance at Injection Site Overall Summary: Number of Participants With no Local Tolerance Event (Itching, Pain, Redness or Swelling) and With a Mild, Moderate and Severe Local Tolerance Event in Any of 3 Treatment Cycles
Hide Description At 30 minutes after dosing in each treatment cycle, the corifollitropin alfa injection site was assessed for the presence of itching, pain, redness and swelling, each of which was scored as none (no event), mild, moderate or severe. This measure reports results considering the occurrence of any of the defined local tolerance events. A participant with an event was counted once in this analysis.
Time Frame 30 minutes post dose in each treatment cycle
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received corifollitropin alfa
Arm/Group Title Corifollitropin Alfa 150 µg
Hide Arm/Group Description:
Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
Overall Number of Participants Analyzed 682
Measure Type: Number
Unit of Measure: participants
None 647
Mild 35
Moderate 0
Severe 0
7.Primary Outcome
Title Number of Participants With AEs
Hide Description An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Time Frame Up to approximately 26 months after first dose of corifollitropin alfa
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received corifollitropin alfa
Arm/Group Title Corifollitropin Alfa 150 µg
Hide Arm/Group Description:
Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
Overall Number of Participants Analyzed 682
Measure Type: Number
Unit of Measure: participants
409
8.Primary Outcome
Title Number of Participants With Serious AEs (SAEs)
Hide Description An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was a congenital anomaly/birth defect. SAEs that occurred in fetuses or infants during the study period are included in this summary of SAEs, and are allocated to the associated study participant who was administered corifollitropin alfa.
Time Frame Up to approximately 26 months after first dose of corifollitropin alfa
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received corifollitropin alfa
Arm/Group Title Corifollitropin Alfa 150 µg
Hide Arm/Group Description:
Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
Overall Number of Participants Analyzed 682
Measure Type: Number
Unit of Measure: participants
51
9.Primary Outcome
Title Number of Participants With Moderate to Severe Ovarian Hyperstimulation Syndrome (OHSS)
Hide Description OHSS was classified on study based on a slightly modified WHO Scientific Group (1973) classification: Grade I (mild) = characterized by excessive steroid secretion and ovarian enlargement (5-7 cm). Abdominal discomfort, including abdominal pain, is present. Grade II (moderate) = characterized by distinct ovarian cysts (ovary size 8-10 cm), accompanied by abdominal pain and tension, nausea, vomiting, diarrhea. Grade III (severe) = characterized by enlarged cystic ovaries (ovary size >10 cm), accompanied by ascites and occasionally hydrothorax. Abdominal tension and pain may be severe. Pronounced hydrothorax together with an abdominal cavity filled with cysts and fluid elevating the diaphragm may cause severe breathing difficulties. Large quantities of fluid inside the cysts and in the peritoneal and pleural cavities cause haemoconcentration and increased blood viscosity. In rare cases, the syndrome may further be complicated by the occurrence of thromboembolic phenomena.
Time Frame Up to approximately 1 month after oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), within a treatment cycle
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received corifollitropin alfa
Arm/Group Title Corifollitropin Alfa 150 µg
Hide Arm/Group Description:
Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
Overall Number of Participants Analyzed 682
Measure Type: Number
Unit of Measure: participants
Cycle 1 (n=682) 12
Cycle 2 (n=375) 4
Cycle 3 (n=198) 0
10.Secondary Outcome
Title Amount of (Rec)FSH Needed From Stimulation Day 8 Onwards to Reach the Criterion for Administration of (Rec)hCG
Hide Description Beginning on Stimulation Day 8 of each treatment cycle, (rec)FSH was administered daily until the criteria for administration of (rec)hCG (presence of 3 follicles ≥17 mm documented by ultrasonography) was reached. The total amount of (rec)FSH administered in each participant to reach the criteria for (rec)hCG administration was calculated.
Time Frame Stimulation Day 8 to day of (rec)hCG administration (approximately Stimulation Day 10), within a treatment cycle
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received corifollitropin alfa and (rec)hCG
Arm/Group Title Corifollitropin Alfa 150 µg
Hide Arm/Group Description:
Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
Overall Number of Participants Analyzed 664
Median (Full Range)
Unit of Measure: International Unit (IU)
Cycle 1 (n=658)
400.0
(0 to 2100)
Cycle 2 (n=364)
450.0
(0 to 1950)
Cycle 3 (n=190)
450.0
(0 to 2250)
11.Secondary Outcome
Title Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Stimulation Day 1 During Treatment Cycle 1
Hide Description For each participant, the number of follicles ≥11 mm, ≥15 mm and ≥17 mm documented by ultrasonography on defined days during the treatment cycle was calculated.
Time Frame Stimulation Day 1 in Treatment Cycle 1
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received corifollitropin alfa and had data for assessment of follicles ≥11 mm on Stimulation Day 1 in Treatment Cycle 1
Arm/Group Title Corifollitropin Alfa 150 µg
Hide Arm/Group Description:
Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
Overall Number of Participants Analyzed 666
Mean (Standard Deviation)
Unit of Measure: follicles
follicles ≥11 mm 0.0  (0.1)
follicles ≥15 mm 0.0  (0.1)
follicles ≥17 mm 0.0  (0.1)
12.Secondary Outcome
Title Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Stimulation Day 1 During Treatment Cycle 2
Hide Description For each participant, the number of follicles ≥11 mm, ≥15 mm and ≥17 mm documented by ultrasonography on defined days during the treatment cycle was calculated.
Time Frame Stimulation Day 1 in Treatment Cycle 2
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received corifollitropin alfa and had data for assessment of follicles ≥11 mm on Stimulation Day 1 in Treatment Cycle 2
Arm/Group Title Corifollitropin Alfa 150 µg
Hide Arm/Group Description:
Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
Overall Number of Participants Analyzed 370
Mean (Standard Deviation)
Unit of Measure: follicles
follicles ≥11 mm 0.0  (0.3)
follicles ≥15 mm 0.0  (0.0)
follicles ≥17 mm 0.0  (0.0)
13.Secondary Outcome
Title Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Stimulation Day 1 During Treatment Cycle 3
Hide Description For each participant, the number of follicles ≥11 mm, ≥15 mm and ≥17 mm documented by ultrasonography on defined days during the treatment cycle was calculated.
Time Frame Stimulation Day 1 in Treatment Cycle 3
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received corifollitropin alfa and had data for assessment of follicles ≥11 mm on Stimulation Day 1 in Treatment Cycle 3
Arm/Group Title Corifollitropin Alfa 150 µg
Hide Arm/Group Description:
Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
Overall Number of Participants Analyzed 196
Mean (Standard Deviation)
Unit of Measure: follicles
follicles ≥11 mm 0.0  (0.2)
follicles ≥15 mm 0.0  (0.0)
follicles ≥17 mm 0.0  (0.0)
14.Secondary Outcome
Title Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Stimulation Day 5 or 6 During Treatment Cycle 1
Hide Description For each participant, the number of follicles ≥11 mm, ≥15 mm and ≥17 mm documented by ultrasonography on defined days during the treatment cycle was calculated.
Time Frame Stimulation Day 5 or 6 in Treatment Cycle 1
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received corifollitropin alfa and had data for assessment of follicles ≥11 mm on Stimulation Day 5 or 6 in Treatment Cycle 1
Arm/Group Title Corifollitropin Alfa 150 µg
Hide Arm/Group Description:
Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
Overall Number of Participants Analyzed 677
Mean (Standard Deviation)
Unit of Measure: follicles
follicles ≥11 mm 5.1  (4.2)
follicles ≥15 mm 0.4  (1.0)
follicles ≥17 mm 0.1  (0.3)
15.Secondary Outcome
Title Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Stimulation Day 5 or 6 During Treatment Cycle 2
Hide Description For each participant, the number of follicles ≥11 mm, ≥15 mm and ≥17 mm documented by ultrasonography on defined days during the treatment cycle was calculated.
Time Frame Stimulation Day 5 or 6 in Treatment Cycle 2
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received corifollitropin alfa and had data for assessment of follicles ≥11 mm on Stimulation Day 5 or 6 in Treatment Cycle 2
Arm/Group Title Corifollitropin Alfa 150 µg
Hide Arm/Group Description:
Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
Overall Number of Participants Analyzed 372
Mean (Standard Deviation)
Unit of Measure: follicles
follicles ≥11 mm 4.8  (4.1)
follicles ≥15 mm 0.4  (1.0)
follicles ≥17 mm 0.1  (0.4)
16.Secondary Outcome
Title Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Stimulation Day 5 or 6 During Treatment Cycle 3
Hide Description For each participant, the number of follicles ≥11 mm, ≥15 mm and ≥17 mm documented by ultrasonography on defined days during the treatment cycle was calculated.
Time Frame Stimulation Day 5 or 6 in Treatment Cycle 3
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received corifollitropin alfa and had data for assessment of follicles ≥11 mm on Stimulation Day 5 or 6 in Treatment Cycle 3
Arm/Group Title Corifollitropin Alfa 150 µg
Hide Arm/Group Description:
Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
Overall Number of Participants Analyzed 198
Mean (Standard Deviation)
Unit of Measure: follicles
follicles ≥11 mm 4.0  (3.3)
follicles ≥15 mm 0.3  (0.9)
follicles ≥17 mm 0.0  (0.3)
17.Secondary Outcome
Title Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Stimulation Day 8 During Treatment Cycle 1
Hide Description For each participant, the number of follicles ≥11 mm, ≥15 mm and ≥17 mm documented by ultrasonography on defined days during the treatment cycle was calculated.
Time Frame Stimulation Day 8 in Treatment Cycle 1
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received corifollitropin alfa and had data for assessment of follicles ≥11 mm on Stimulation Day 8 in Treatment Cycle 1
Arm/Group Title Corifollitropin Alfa 150 µg
Hide Arm/Group Description:
Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
Overall Number of Participants Analyzed 660
Mean (Standard Deviation)
Unit of Measure: follicles
follicles ≥11 mm 11.1  (5.9)
follicles ≥15 mm 3.7  (3.3)
follicles ≥17 mm 1.1  (1.8)
18.Secondary Outcome
Title Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Stimulation Day 8 During Treatment Cycle 2
Hide Description For each participant, the number of follicles ≥11 mm, ≥15 mm and ≥17 mm documented by ultrasonography on defined days during the treatment cycle was calculated.
Time Frame Stimulation Day 8 in Treatment Cycle 2
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received corifollitropin alfa and had data for assessment of follicles ≥11 mm on Stimulation Day 8 in Treatment Cycle 2
Arm/Group Title Corifollitropin Alfa 150 µg
Hide Arm/Group Description:
Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
Overall Number of Participants Analyzed 363
Mean (Standard Deviation)
Unit of Measure: follicles
follicles ≥11 mm 10.7  (5.4)
follicles ≥15 mm 3.6  (3.3)
follicles ≥17 mm 1.2  (1.8)
19.Secondary Outcome
Title Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Stimulation Day 8 During Treatment Cycle 3
Hide Description For each participant, the number of follicles ≥11 mm, ≥15 mm and ≥17 mm documented by ultrasonography on defined days during the treatment cycle was calculated.
Time Frame Stimulation Day 8 in Treatment Cycle 3
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received corifollitropin alfa and had data for assessment of follicles ≥11 mm on Stimulation Day 8 in Treatment Cycle 3
Arm/Group Title Corifollitropin Alfa 150 µg
Hide Arm/Group Description:
Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
Overall Number of Participants Analyzed 194
Mean (Standard Deviation)
Unit of Measure: follicles
follicles ≥11 mm 10.0  (5.8)
follicles ≥15 mm 3.4  (3.3)
follicles ≥17 mm 1.1  (1.8)
20.Secondary Outcome
Title Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Day of (Rec)hCG Administration During Treatment Cycle 1
Hide Description For each participant, the number of follicles ≥11 mm, ≥15 mm and ≥17 mm documented by ultrasonography on the day of (rec)hCG administration during the treatment cycle was recorded.
Time Frame Day of (rec)hCG administration (approximately Stimulation Day 10) in Treatment Cycle 1
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received corifollitropin alfa and (rec)hCG, and had data for assessment of follicles ≥11 mm on day of (rec)hCG administration in Treatment Cycle 1
Arm/Group Title Corifollitropin Alfa 150 µg
Hide Arm/Group Description:
Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
Overall Number of Participants Analyzed 640
Mean (Standard Deviation)
Unit of Measure: follicles
follicles ≥11 mm 14.5  (6.4)
follicles ≥15 mm 9.2  (4.3)
follicles ≥17 mm 5.4  (2.8)
21.Secondary Outcome
Title Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Day of (Rec)hCG Administration During Treatment Cycle 2
Hide Description For each participant, the number of follicles ≥11 mm, ≥15 mm and ≥17 mm documented by ultrasonography on the day of (rec)hCG administration during the treatment cycle was recorded.
Time Frame Day of (rec)hCG administration (approximately Stimulation Day 10) in Treatment Cycle 2
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received corifollitropin alfa and (rec)hCG, and had data for assessment of follicles ≥11 mm on day of (rec)hCG administration in Treatment Cycle 2
Arm/Group Title Corifollitropin Alfa 150 µg
Hide Arm/Group Description:
Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
Overall Number of Participants Analyzed 359
Mean (Standard Deviation)
Unit of Measure: follicles
follicles ≥11 mm 13.9  (6.0)
follicles ≥15 mm 9.0  (3.9)
follicles ≥17 mm 5.4  (2.7)
22.Secondary Outcome
Title Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Day of (Rec)hCG Administration During Treatment Cycle 3
Hide Description For each participant, the number of follicles ≥11 mm, ≥15 mm and ≥17 mm documented by ultrasonography on the day of (rec)hCG administration during the treatment cycle was recorded.
Time Frame Day of (rec)hCG administration (approximately Stimulation Day 10) in Treatment Cycle 3
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received corifollitropin alfa and (rec)hCG, and had data for assessment of follicles ≥11 mm on day of (rec)hCG administration in Treatment Cycle 3
Arm/Group Title Corifollitropin Alfa 150 µg
Hide Arm/Group Description:
Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
Overall Number of Participants Analyzed 185
Mean (Standard Deviation)
Unit of Measure: follicles
follicles ≥11 mm 13.7  (6.4)
follicles ≥15 mm 9.0  (4.7)
follicles ≥17 mm 5.4  (2.9)
23.Secondary Outcome
Title Number of Oocytes Retrieved in a Participant Among Entire Study Population
Hide Description Oocyte retrieval, also known as oocyte pick-up, is a technique used in in vitro fertilization (IVF) and intracytoplasmic sperm injection (ICSI) in order to remove oocytes from the ovary of the female, enabling fertilization outside the body. The number of oocytes retrieved, per participant, is summarized.
Time Frame Day of oocyte pick-up, 34-36 hours after (rec)hCG administration (approximately Stimulation Day 10), within a treatment cycle
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received corifollitropin alfa
Arm/Group Title Corifollitropin Alfa 150 µg
Hide Arm/Group Description:
Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
Overall Number of Participants Analyzed 682
Mean (Standard Deviation)
Unit of Measure: number of oocytes
Cycle 1 (n=682) 11.9  (7.2)
Cycle 2 (n=375) 11.5  (6.8)
Cycle 3 (n=198) 11.3  (7.6)
24.Secondary Outcome
Title Quality of Oocytes Assessed Prior to Planned ICSI in Treatment Cycle 1
Hide Description This measure summarizes results of assessment of the quality of oocytes performed following oocyte retrieval, among participants scheduled for ICSI in Treatment Cycle 1. For oocytes obtained from each participant, the number in each of 3 stages of oocyte development were determined. The earliest phase is the germinal vesicles stage, during which the immature oocyte appears as a large vesicular nucleus. Metaphase I is an intermediate stage during which the vesicles have broken down and the polar body has not yet formed; the oocyte is still immature. Metaphase II is the mature oocyte and is indicated by the presence of the polar body. Rating of quality for usefulness in ICSI follows the order metaphase II (best quality), metaphase I (lesser quality) and germinal vesicles stage (poorest quality). Only metaphase II oocytes can be fertilized. Metaphase I oocytes can develop in vitro to metaphase II oocytes. Germinal vesicles stage oocytes are the least useful for ICSI procedures.
Time Frame Day of oocyte pick-up, 34-36 hours after (rec)hCG administration (approximately Stimulation Day 10), in Treatment Cycle 1
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received corifollitropin alfa and were to have ICSI in Treatment Cycle 1
Arm/Group Title Corifollitropin Alfa 150 µg
Hide Arm/Group Description:
Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
Overall Number of Participants Analyzed 462
Mean (Standard Deviation)
Unit of Measure: number of oocytes
Oocytes assessed 12.2  (7.0)
Metaphase I 0.8  (1.4)
Metaphase II 9.8  (6.0)
Germinal vesicles stage 0.9  (1.4)
25.Secondary Outcome
Title Quality of Oocytes Assessed Prior to Planned ICSI in Treatment Cycle 2
Hide Description This measure summarizes results of assessment of the quality of oocytes performed following oocyte retrieval, among participants scheduled for ICSI in Treatment Cycle 2. For oocytes obtained from each participant, the number in each of 3 stages of oocyte development were determined. The earliest phase is the germinal vesicles stage, during which the immature oocyte appears as a large vesicular nucleus. Metaphase I is an intermediate stage during which the vesicles have broken down and the polar body has not yet formed; the oocyte is still immature. Metaphase II is the mature oocyte and is indicated by the presence of the polar body. Rating of quality for usefulness in ICSI follows the order metaphase II (best quality), metaphase I (lesser quality) and germinal vesicles stage (poorest quality). Only metaphase II oocytes can be fertilized. Metaphase I oocytes can develop in vitro to metaphase II oocytes. Germinal vesicles stage oocytes are the least useful for ICSI procedures.
Time Frame Day of oocyte pick-up, 34-36 hours after (rec)hCG administration (approximately Stimulation Day 10), in Treatment Cycle 2
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received corifollitropin alfa and were to have ICSI in Treatment Cycle 2
Arm/Group Title Corifollitropin Alfa 150 µg
Hide Arm/Group Description:
Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
Overall Number of Participants Analyzed 281
Mean (Standard Deviation)
Unit of Measure: number of oocytes
Oocytes assessed 11.6  (6.5)
Metaphase I 0.9  (1.5)
Metaphase II 9.3  (5.4)
Germinal vesicles stage 0.8  (1.4)
26.Secondary Outcome
Title Quality of Oocytes Assessed Prior to Planned ICSI in Treatment Cycle 3
Hide Description This measure summarizes results of assessment of the quality of oocytes performed following oocyte retrieval, among participants scheduled for ICSI in Treatment Cycle 3. For oocytes obtained from each participant, the number in each of 3 stages of oocyte development were determined. The earliest phase is the germinal vesicles stage, during which the immature oocyte appears as a large vesicular nucleus. Metaphase I is an intermediate stage during which the vesicles have broken down and the polar body has not yet formed; the oocyte is still immature. Metaphase II is the mature oocyte and is indicated by the presence of the polar body. Rating of quality for usefulness in ICSI follows the order metaphase II (best quality), metaphase I (lesser quality) and germinal vesicles stage (poorest quality). Only metaphase II oocytes can be fertilized. Metaphase I oocytes can develop in vitro to metaphase II oocytes. Germinal vesicles stage oocytes are the least useful for ICSI procedures.
Time Frame Day of oocyte pick-up, 34-36 hours after (rec)hCG administration (approximately Stimulation Day 10), in Treatment Cycle 3
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received corifollitropin alfa and were to have ICSI in Treatment Cycle 3
Arm/Group Title Corifollitropin Alfa 150 µg
Hide Arm/Group Description:
Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
Overall Number of Participants Analyzed 151
Mean (Standard Deviation)
Unit of Measure: number of oocytes
Oocytes assessed 11.3  (6.3)
Metaphase I 0.8  (1.3)
Metaphase II 9.1  (5.2)
Germinal vesicles stage 0.9  (1.5)
27.Secondary Outcome
Title Number of Fertilized Oocytes Obtained in Treatment Cycle 1
Hide Description This measure presents the number of fertilized oocytes obtained per participant from the IVF or ISCI procedure, by category of number of pronuclei (PN) present: 0 PN, 1 PN, 2 PN, ≥3 PN, other (fertilized oocyte that was not placed in PN category). Normal fertilized ooctyes have 2 pronuclei (2 PN).
Time Frame 16-18 hours after start of IVF or ICSI, which occurs on day of oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 1
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received corifollitropin alfa and had IVF and/or ICSI in Treatment Cycle 1
Arm/Group Title Corifollitropin Alfa 150 µg
Hide Arm/Group Description:
Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
Overall Number of Participants Analyzed 649
Mean (Standard Deviation)
Unit of Measure: number of fertilized oocytes
0 PN fertilized oocytes 2.2  (2.9)
1 PN fertilized oocytes 0.2  (0.6)
2 PN fertilized oocytes 6.1  (4.0)
≥3 PN fertilized oocytes 0.3  (0.7)
Other fertilized oocytes 0.7  (1.6)
28.Secondary Outcome
Title Number of Fertilized Oocytes Obtained in Treatment Cycle 2
Hide Description This measure presents the number of fertilized oocytes obtained per participant from the IVF or ISCI procedure, by category of number of PN present: 0 PN, 1 PN, 2 PN, ≥3 PN, other (fertilized oocyte that was not placed in PN category). Normal fertilized ooctyes have 2 pronuclei (2 PN).
Time Frame 16-18 hours after start of IVF or ICSI, which occurs on day of oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 2
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received corifollitropin alfa and had IVF and/or ICSI in Treatment Cycle 2
Arm/Group Title Corifollitropin Alfa 150 µg
Hide Arm/Group Description:
Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
Overall Number of Participants Analyzed 359
Mean (Standard Deviation)
Unit of Measure: number of fertilized oocytes
0 PN fertilized oocytes 2.1  (2.5)
1 PN fertilized oocytes 0.3  (0.9)
2 PN fertilized oocytes 6.1  (4.0)
≥3 PN fertilized oocytes 0.3  (0.7)
Other fertilized oocytes 0.6  (1.2)
29.Secondary Outcome
Title Number of Fertilized Oocytes Obtained in Treatment Cycle 3
Hide Description This measure presents the number of fertilized oocytes obtained per participant from the IVF or ISCI procedure, by category of number of PN present: 0 PN, 1 PN, 2 PN, ≥3 PN, other (fertilized oocyte that was not placed in PN category). Normal fertilized ooctyes have 2 pronuclei (2 PN).
Time Frame 16-18 hours after start of IVF or ICSI, which occurs on day of oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 3
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received corifollitropin alfa and had IVF and/or ICSI in Treatment Cycle 3
Arm/Group Title Corifollitropin Alfa 150 µg
Hide Arm/Group Description:
Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
Overall Number of Participants Analyzed 188
Mean (Standard Deviation)
Unit of Measure: number of fertilized oocytes
0 PN fertilized oocytes 1.8  (2.3)
1 PN fertilized oocytes 0.2  (0.5)
2 PN fertilized oocytes 6.2  (4.2)
≥3 PN fertilized oocytes 0.3  (0.7)
Other fertilized oocytes 0.8  (1.6)
30.Secondary Outcome
Title Number of Fertilized Oocytes Obtained That Were Frozen in Treatment Cycle 1
Hide Description This measure presents the number of fertilized oocytes obtained per participant from the IVF or ICSI procedure that were cryopreserved (frozen) for possible later use, by category of number of PN present: 0 PN, 1 PN, 2 PN, ≥3 PN, other (fertilized oocyte that was not placed in PN category). Normal fertilized ooctyes have 2 pronuclei (2 PN).
Time Frame 16-18 hours after start of IVF or ICSI, which occurs on day of oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 1
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received corifollitropin alfa and had IVF and/or ICSI in Treatment Cycle 1, and were enrolled at a site using cyropreservation at the fertilized oocyte level
Arm/Group Title Corifollitropin Alfa 150 µg
Hide Arm/Group Description:
Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
Overall Number of Participants Analyzed 103
Mean (Standard Deviation)
Unit of Measure: number of fertilized oocytes
0 PN fertilized oocytes 0.0  (0.0)
1 PN fertilized oocytes 0.0  (0.1)
2 PN fertilized oocytes 1.9  (3.2)
≥3 PN fertilized oocytes 0.0  (0.0)
Other fertilized oocytes 0.0  (0.0)
31.Secondary Outcome
Title Number of Fertilized Oocytes Obtained That Were Frozen in Treatment Cycle 2
Hide Description This measure presents the number of fertilized oocytes obtained per participant from the IVF or ICSI procedure that were cryopreserved (frozen) for possible later use, by category of number of PN present: 0 PN, 1 PN, 2 PN, ≥3 PN, other (fertilized oocyte that was not placed in PN category). Normal fertilized ooctyes have 2 pronuclei (2 PN).
Time Frame 16-18 hours after start of IVF or ICSI, which occurs on day of oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 2
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received corifollitropin alfa and had IVF and/or ICSI in Treatment Cycle 2, and were enrolled at a site using cyropreservation at the fertilized oocyte level
Arm/Group Title Corifollitropin Alfa 150 µg
Hide Arm/Group Description:
Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
Overall Number of Participants Analyzed 55
Mean (Standard Deviation)
Unit of Measure: number of fertilized oocytes
0 PN fertilized oocytes 0.0  (0.0)
1 PN fertilized oocytes 0.0  (0.0)
2 PN fertilized oocytes 1.6  (3.3)
≥3 PN fertilized oocytes 0.0  (0.0)
Other fertilized oocytes 0.0  (0.0)
32.Secondary Outcome
Title Number of Fertilized Oocytes Obtained That Were Frozen in Treatment Cycle 3
Hide Description This measure presents the number of fertilized oocytes obtained per participant from the IVF or ICSI procedure that were cryopreserved (frozen) for possible later use, by category of number of PN present: 0 PN, 1 PN, 2 PN, ≥3 PN, other (fertilized oocyte that was not placed in PN category). Normal fertilized ooctyes have 2 pronuclei (2 PN).
Time Frame 16-18 hours after start of IVF or ICSI, which occurs on day of oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 3
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received corifollitropin alfa and had IVF and/or ICSI in Treatment Cycle 3, and were enrolled at a site using cyropreservation at the fertilized oocyte level
Arm/Group Title Corifollitropin Alfa 150 µg
Hide Arm/Group Description:
Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
Overall Number of Participants Analyzed 32
Mean (Standard Deviation)
Unit of Measure: number of fertilized oocytes
0 PN fertilized oocytes 0.0  (0.0)
1 PN fertilized oocytes 0.0  (0.0)
2 PN fertilized oocytes 1.1  (2.1)
≥3 PN fertilized oocytes 0.0  (0.0)
Other fertilized oocytes 0.0  (0.0)
33.Secondary Outcome
Title Number of Fertilized Oocytes Obtained That Were Used for Embryo Development in Treatment Cycle 1
Hide Description This measure presents the number of fertilized oocytes obtained per participant from the IVF or ISCI procedure that were used for embryo development, by category of number of PN present: 0 PN, 1 PN, 2 PN, ≥3 PN, other (fertilized oocyte that was not placed in PN category). Normal fertilized ooctyes have 2 pronuclei (2 PN).
Time Frame 16-18 hours after start of IVF or ICSI, which occurs on day of oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 1
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received corifollitropin alfa and had IVF and/or ICSI in Treatment Cycle 1
Arm/Group Title Corifollitropin Alfa 150 µg
Hide Arm/Group Description:
Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
Overall Number of Participants Analyzed 649
Mean (Standard Deviation)
Unit of Measure: number of fertilized oocytes
0 PN fertilized oocytes 0.6  (1.9)
1 PN fertilized oocytes 0.1  (0.3)
2 PN fertilized oocytes 5.7  (4.1)
≥3 PN fertilized oocytes 0.0  (0.0)
Other fertilized oocytes 0.0  (0.1)
34.Secondary Outcome
Title Number of Fertilized Oocytes Obtained That Were Used for Embryo Development in Treatment Cycle 2
Hide Description This measure presents the number of fertilized oocytes obtained per participant from the IVF or ISCI procedure that were used for embryo development, by category of number of PN present: 0 PN, 1 PN, 2 PN, ≥3 PN, other (fertilized oocyte that was not placed in PN category). Normal fertilized ooctyes have 2 pronuclei (2 PN).
Time Frame 16-18 hours after start of IVF or ICSI, which occurs on day of oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 2
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received corifollitropin alfa and had IVF and/or ICSI in Treatment Cycle 2
Arm/Group Title Corifollitropin Alfa 150 µg
Hide Arm/Group Description:
Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
Overall Number of Participants Analyzed 359
Mean (Standard Deviation)
Unit of Measure: number of fertilized oocytes
0 PN fertilized oocytes 0.6  (1.8)
1 PN fertilized oocytes 0.1  (0.8)
2 PN fertilized oocytes 5.8  (3.9)
≥3 PN fertilized oocytes 0.0  (0.0)
Other fertilized oocytes 0.0  (0.2)
35.Secondary Outcome
Title Number of Fertilized Oocytes Obtained That Were Used for Embryo Development in Treatment Cycle 3
Hide Description This measure presents the number of fertilized oocytes obtained per participant from the IVF or ISCI procedure that were used for embryo development, by category of number of PN present: 0 PN, 1 PN, 2 PN, ≥3 PN, other (fertilized oocyte that was not placed in PN category). Normal fertilized ooctyes have 2 pronuclei (2 PN).
Time Frame 16-18 hours after start of IVF or ICSI, which occurs on day of oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 3
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received corifollitropin alfa and had IVF and/or ICSI in Treatment Cycle 3
Arm/Group Title Corifollitropin Alfa 150 µg
Hide Arm/Group Description:
Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
Overall Number of Participants Analyzed 188
Mean (Standard Deviation)
Unit of Measure: number of fertilized oocytes
0 PN fertilized oocytes 0.5  (1.6)
1 PN fertilized oocytes 0.1  (0.4)
2 PN fertilized oocytes 6.0  (4.2)
≥3 PN fertilized oocytes 0.0  (0.1)
Other fertilized oocytes 0.1  (0.6)
36.Secondary Outcome
Title Fertilization Rate
Hide Description The fertilization rate (in percent) is defined as 100 times the ratio of the number of fertilized 2 PN oocytes obtained and the number of oocytes that was used for fertilization, per participant.
Time Frame 16-18 hours after start of IVF or ICSI, which occurs on day of oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), within a treatment cycle
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received corifollitropin alfa and had IVF and/or ICSI
Arm/Group Title Corifollitropin Alfa 150 µg
Hide Arm/Group Description:
Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
Overall Number of Participants Analyzed 659
Mean (Standard Deviation)
Unit of Measure: percentage of oocytes
Cycle 1 (n=649) 67.0  (26.6)
Cycle 2 (n=359) 66.0  (25.8)
Cycle 3 (n=188) 67.3  (23.4)
37.Secondary Outcome
Title Number and Quality of Embryos Obtained at Day 3 After Oocyte Pick-up in Treatment Cycle 1
Hide Description At Day 3 after oocyte pick-up, embryos obtained from IVF or ISCI process for each participant were counted and quality was assessed. Quality was rated as Grade 1, 2 or 3, or “other grade”, with Grade 1 representing the best quality. The 2 highest quality grades (Grade 1 + 2) were combined into a summary category of “good quality.”
Time Frame Day 3 after oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 1
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received corifollitropin alfa and had IVF and/or ICSI in Treatment Cycle 1 and had embryo assessment at Day 3 after oocyte pick-up; excludes participants with embryo transfer or embryos cryopreserved before Day 3
Arm/Group Title Corifollitropin Alfa 150 µg
Hide Arm/Group Description:
Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
Overall Number of Participants Analyzed 610
Mean (Standard Deviation)
Unit of Measure: number of embryos
Total obtained 6.4  (4.5)
Good quality (Grade 1 + 2) 3.2  (3.1)
Grade 1 1.2  (2.1)
Grade 2 1.9  (2.3)
Grade 3 2.3  (2.5)
Other grade 1.0  (2.1)
38.Secondary Outcome
Title Number and Quality of Embryos Obtained at Day 3 After Oocyte Pick-up in Treatment Cycle 2
Hide Description At Day 3 after oocyte pick-up, embryos obtained from IVF or ISCI process for each participant were counted and quality was assessed. Quality was rated as Grade 1, 2 or 3, or “other grade”, with Grade 1 representing the best quality. The 2 highest quality grades (Grade 1 + 2) were combined into a summary category of “good quality.”
Time Frame Day 3 after oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 2
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received corifollitropin alfa and had IVF and/or ICSI in Treatment Cycle 2 and had embryo assessment at Day 3 after oocyte pick-up; excludes participants with embryo transfer or embryos cryopreserved before Day 3
Arm/Group Title Corifollitropin Alfa 150 µg
Hide Arm/Group Description:
Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
Overall Number of Participants Analyzed 351
Mean (Standard Deviation)
Unit of Measure: number of embryos
Total obtained 6.5  (4.4)
Good quality (Grade 1 + 2) 2.9  (2.8)
Grade 1 1.2  (1.9)
Grade 2 1.8  (2.0)
Grade 3 2.4  (2.7)
Other grade 1.2  (2.4)
39.Secondary Outcome
Title Number and Quality of Embryos Obtained at Day 3 After Oocyte Pick-up in Treatment Cycle 3
Hide Description At Day 3 after oocyte pick-up, embryos obtained from IVF or ISCI process for each participant were counted and quality was assessed. Quality was rated as Grade 1, 2 or 3, or “other grade”, with Grade 1 representing the best quality. The 2 highest quality grades (Grade 1 + 2) were combined into a summary category of “good quality.”
Time Frame Day 3 after oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 3
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received corifollitropin alfa and had IVF and/or ICSI in Treatment Cycle 3 and had embryo assessment at Day 3 after oocyte pick-up; excludes participants with embryo transfer or embryos cryopreserved before Day 3
Arm/Group Title Corifollitropin Alfa 150 µg
Hide Arm/Group Description:
Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
Overall Number of Participants Analyzed 186
Mean (Standard Deviation)
Unit of Measure: number of embryos
Total obtained 6.6  (4.8)
Good quality (Grade 1 + 2) 2.8  (2.7)
Grade 1 1.0  (1.9)
Grade 2 1.8  (2.0)
Grade 3 2.6  (3.0)
Other grade 1.1  (2.2)
40.Secondary Outcome
Title Number of Embryos Transferred
Hide Description ET is the procedure in which one or more embryos are placed in the uterus. The number of embryos transferred, per participant, is summarized.
Time Frame At ET, Day 3 or Day 5 after oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), within a treatment cycle
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received corifollitropin alfa and had ET
Arm/Group Title Corifollitropin Alfa 150 µg
Hide Arm/Group Description:
Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
Overall Number of Participants Analyzed 642
Mean (Standard Deviation)
Unit of Measure: number of embryos
Cycle 1 (n=616) 1.9  (0.7)
Cycle 2 (n=340) 2.1  (0.7)
Cycle 3 (n=178) 2.2  (0.7)
41.Secondary Outcome
Title Number of Participants by Category of Number of Good Quality Embryos Transferred in Treatment Cycle 1
Hide Description The number of embryos transferred, for each participant, by category of number of “good quality” embryos transferred, is summarized. Quality was rated as Grade 1, 2 or 3, or “other grade”, with Grade 1 representing the best quality. The 2 highest quality grades (Grade 1 + 2) were combined into a summary category of “good quality.”
Time Frame At ET, Day 3 or Day 5 after oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 1
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received corifollitropin alfa and had ET in Treatment Cycle 1
Arm/Group Title Corifollitropin Alfa 150 µg
Hide Arm/Group Description:
Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
Overall Number of Participants Analyzed 616
Measure Type: Number
Unit of Measure: participants
With 0 good quality embryos transferred 110
With 1 good quality embryo transferred 230
With 2 good quality embryos transferred 201
With 3 good quality embryos transferred 75
42.Secondary Outcome
Title Number of Participants by Category of Number of Good Quality Embryos Transferred in Treatment Cycle 2
Hide Description The number of embryos transferred, for each participant, by category of number of “good quality” embryos transferred, is summarized. Quality was rated as Grade 1, 2 or 3, or “other grade”, with Grade 1 representing the best quality. The 2 highest quality grades (Grade 1 + 2) were combined into a summary category of “good quality.”
Time Frame At ET, Day 3 or Day 5 after oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 2
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received corifollitropin alfa and had ET in Treatment Cycle 2
Arm/Group Title Corifollitropin Alfa 150 µg
Hide Arm/Group Description:
Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
Overall Number of Participants Analyzed 340
Measure Type: Number
Unit of Measure: participants
With 0 good quality embryos transferred 81
With 1 good quality embryo transferred 80
With 2 good quality embryos transferred 122
With 3 good quality embryos transferred 57
43.Secondary Outcome
Title Number of Participants by Category of Number of Good Quality Embryos Transferred in Treatment Cycle 3
Hide Description The number of embryos transferred, for each participant, by category of number of “good quality” embryos transferred, is summarized. Quality was rated as Grade 1, 2 or 3, or “other grade”, with Grade 1 representing the best quality. The 2 highest quality grades (Grade 1 + 2) were combined into a summary category of “good quality.”
Time Frame At ET, Day 3 or Day 5 after oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 3
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received corifollitropin alfa and had ET in Treatment Cycle 3
Arm/Group Title Corifollitropin Alfa 150 µg
Hide Arm/Group Description:
Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
Overall Number of Participants Analyzed 178
Measure Type: Number
Unit of Measure: participants
With 0 good quality embryos transferred 31
With 1 good quality embryo transferred 49
With 2 good quality embryos transferred 65
With 3 good quality embryos transferred 33
44.Secondary Outcome
Title Number and Quality of Embryos Obtained That Were Frozen in Treatment Cycle 1
Hide Description The number of embryos that were cryopreserved (frozen) for possible later use, for each participant, overall and by embryo quality categories, is summarized. Quality was rated as Grade 1, 2 or 3, or “other grade”, with Grade 1 representing the best quality. The 2 highest quality grades (Grade 1 + 2) were combined into a summary category of “good quality.”
Time Frame Day 3 or Day 5 after oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 1
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received corifollitropin alfa in Treatment Cycle 1
Arm/Group Title Corifollitropin Alfa 150 µg
Hide Arm/Group Description:
Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
Overall Number of Participants Analyzed 682
Mean (Standard Deviation)
Unit of Measure: number of embryos
Total frozen 1.6  (2.7)
Good quality (Grade 1 + 2) 1.2  (2.3)
Grade 1 0.4  (1.2)
Grade 2 0.8  (1.7)
Grade 3 0.4  (1.0)
Other grade 0.1  (0.4)
45.Secondary Outcome
Title Number and Quality of Embryos Obtained That Were Frozen in Treatment Cycle 2
Hide Description The number of embryos that were cryopreserved (frozen) for possible later use, for each participant, overall and by embryo quality categories, is summarized. Quality was rated as Grade 1, 2 or 3, or “other grade”, with Grade 1 representing the best quality. The 2 highest quality grades (Grade 1 + 2) were combined into a summary category of “good quality.”
Time Frame Day 3 or Day 5 after oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 2
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received corifollitropin alfa in Treatment Cycle 2
Arm/Group Title Corifollitropin Alfa 150 µg
Hide Arm/Group Description:
Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
Overall Number of Participants Analyzed 375
Mean (Standard Deviation)
Unit of Measure: number of embryos
Total frozen 1.1  (2.1)
Good quality (Grade 1 + 2) 0.8  (1.7)
Grade 1 0.3  (1.0)
Grade 2 0.5  (1.3)
Grade 3 0.3  (0.9)
Other grade 0.0  (0.4)
46.Secondary Outcome
Title Number and Quality of Embryos Obtained That Were Frozen in Treatment Cycle 3
Hide Description The number of embryos that were cryopreserved (frozen) for possible later use, for each participant, overall and by embryo quality categories, is summarized. Quality was rated as Grade 1, 2 or 3, or “other grade”, with Grade 1 representing the best quality. The 2 highest quality grades (Grade 1 + 2) were combined into a summary category of “good quality.”
Time Frame Day 3 or Day 5 after oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 3
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received corifollitropin alfa in Treatment Cycle 3
Arm/Group Title Corifollitropin Alfa 150 µg
Hide Arm/Group Description:
Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
Overall Number of Participants Analyzed 198
Mean (Standard Deviation)
Unit of Measure: number of embryos
Total frozen 1.1  (2.2)
Good quality (Grade 1 + 2) 0.8  (1.7)
Grade 1 0.3  (1.1)
Grade 2 0.5  (1.3)
Grade 3 0.3  (1.0)
Other grade 0.0  (0.4)
47.Secondary Outcome
Title Implantation Rate for Participants With ET
Hide Description The implantation rate (in percent) is defined as 100 times the maximum number of gestational sacs as assessed by any ultrasound scan after ET divided by the number of embryos transferred per participant.
Time Frame Approximately 5-6 weeks after ET, within a treatment cycle
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received corifollitropin alfa and had ET
Arm/Group Title Corifollitropin Alfa 150 µg
Hide Arm/Group Description:
Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
Overall Number of Participants Analyzed 642
Mean (Standard Deviation)
Unit of Measure: percentage of embryos
Cycle 1 (n=616) 21.2  (36.2)
Cycle 2 (n=340) 16.6  (31.0)
Cycle 3 (n=178) 16.3  (30.0)
48.Secondary Outcome
Title Number of Participants With Biochemical Pregnancy, Clinical Pregnancy, Vital Pregnancy and Ongoing Pregnancy in Any of Treatment Cycles 1, 2 or 3
Hide Description Biochemical pregnancy: Pregnancy proven by a biochemical pregnancy test using urine samples or serum samples collected at least 14 days after ET. Participants not having a positive biochemical pregnancy test result, but with an ultrasound scan showing at least one gestational sac were counted as having a biochemical pregnancy. Clinical pregnancy: Presence of at least one gestational sac as assessed by ultrasound scan. Vital pregnancy: Presence of at least one fetus with heart activity as assessed by ultrasound scan. Ongoing pregnancy: Presence of at least one fetus with heart activity as assessed by ultrasound scan at least 10 weeks after ET, or confirmed by live birth.
Time Frame ≥14 days (for biochemical pregnancy), 5-6 weeks (for clinical pregnancy), 5-6 weeks to 10 weeks (for vital pregnancy) and 10 weeks up to 9 months (for ongoing pregnancy) after ET, within a treatment cycle
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received corifollitropin alfa
Arm/Group Title Corifollitropin Alfa 150 µg
Hide Arm/Group Description:
Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
Overall Number of Participants Analyzed 682
Measure Type: Number
Unit of Measure: participants
Biochemical pregnancy 340
Clinical pregnancy 303
Vital pregnancy 278
Ongoing pregnancy 272
49.Secondary Outcome
Title Number of Participants With Singleton and Multiple Ongoing Pregnancy in Any of Treatment Cycles 1, 2 or 3
Hide Description Singleton pregnancy is a pregnancy in which one fetus develops in the uterus. Multiple pregnancy is a pregnancy in which more than one fetus develops simultaneously in the uterus. Ongoing pregnancy: Presence of at least one fetus with heart activity as assessed by ultrasound scan at least 10 weeks after ET, or confirmed by live birth.
Time Frame 10 weeks up to 9 months after ET, within a treatment cycle
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received corifollitropin alfa and had ongoing pregnancy in any of Treatment Cycles 1, 2 or 3
Arm/Group Title Corifollitropin Alfa 150 µg
Hide Arm/Group Description:
Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
Overall Number of Participants Analyzed 272
Measure Type: Number
Unit of Measure: participants
Singleton ongoing pregnancy 226
Multiple ongoing pregnancy 46
50.Secondary Outcome
Title Number of Participants With Miscarriage Among Participants With Clinical Pregnancy in Any of Treatment Cycles 1, 2 or 3
Hide Description Miscarriage: Loss of the fetus without induction or instrumentation, also known as “spontaneous abortion.” Clinical pregnancy: Presence of at least one gestational sac as assessed by ultrasound scan.
Time Frame 5-6 weeks up to 9 months after ET, within a treatment cycle
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received corifollitropin alfa and had clinical pregnancy in any of Treatment Cycles 1, 2 or 3
Arm/Group Title Corifollitropin Alfa 150 µg
Hide Arm/Group Description:
Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
Overall Number of Participants Analyzed 303
Measure Type: Number
Unit of Measure: participants
37
51.Secondary Outcome
Title Number of Participants With Miscarriage Among Participants With Vital Pregnancy in Any of Treatment Cycles 1, 2 or 3
Hide Description Miscarriage: Loss of the fetus without induction or instrumentation, also known as “spontaneous abortion.” Vital pregnancy: Presence of at least one fetus with heart activity as assessed by ultrasound scan.
Time Frame 5-6 weeks up to 9 months after ET, within a treatment cycle
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received corifollitropin alfa and had vital pregnancy in any of Treatment Cycles 1, 2 or 3
Arm/Group Title Corifollitropin Alfa 150 µg
Hide Arm/Group Description:
Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
Overall Number of Participants Analyzed 278
Measure Type: Number
Unit of Measure: participants
5
52.Secondary Outcome
Title Number of Participants With Ectopic Pregnancy Among Participants With Biochemical Pregnancy in Any of Treatment Cycles 1, 2 or 3
Hide Description Ectopic pregnancy: A pregnancy in which the embryo attaches itself in a place other than inside the uterus. The most common site for an ectopic pregnancy is within one of the two fallopian tubes. Biochemical pregnancy: Pregnancy proven by a biochemical pregnancy test using urine samples or serum samples collected at least 14 days after ET. Participants not having a positive biochemical pregnancy test result, but with an ultrasound scan showing at least one gestational sac were counted as having a biochemical pregnancy.
Time Frame From 2 weeks up to approximately 5-6 weeks after ET, within a treatment cycle
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received corifollitropin alfa and had biochemical pregnancy in any of Treatment Cycles 1, 2 or 3
Arm/Group Title Corifollitropin Alfa 150 µg
Hide Arm/Group Description:
Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
Overall Number of Participants Analyzed 340
Measure Type: Number
Unit of Measure: participants
9
53.Secondary Outcome
Title Number of Participants With Ongoing Pregnancy in Any FTET Cycle
Hide Description After the first and after the second treatment cycle (i.e., a cycle in which corifollitropin alfa was administered for ovarian stimulation), participants could continue with a maximum of three FTET cycles before starting the following treatment cycle. This measure summarizes the number of participants with ongoing pregnancy following ET within an FTET cycle. Ongoing pregnancy: Presence of at least one fetus with heart activity as assessed by ultrasound scan at least 10 weeks after ET, or confirmed by live birth.
Time Frame 10 weeks up to 9 months after ET within an FTET cycle
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received corifollitropin alfa and had ET in any FTET cycle
Arm/Group Title Corifollitropin Alfa 150 µg
Hide Arm/Group Description:
Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
Overall Number of Participants Analyzed 209
Measure Type: Number
Unit of Measure: participants
48
54.Secondary Outcome
Title Cumulative Ongoing Pregnancy Rate: Percentage of Participants With Ongoing Pregnancy in Treatment Cycles 1, 2 or 3, or in Any FTET Cycle, or Who Had Ongoing Pregnancy That Was a Spontaneous Pregnancy
Hide Description The ongoing pregnancy rate, cumulative over the entire study (in percent), is defined as 100 times the number of participants who had an ongoing pregnancy in Treatment Cycles 1, 2 or 3, or in any FTET cycle, or who had a spontaneous ongoing pregnancy, divided by the total number of participants who were administered corifollitropin alfa in the study. A participant could only be represented once in the count of ongoing pregnancies for determination of cumulative ongoing pregnancy rate. After the first and after the second treatment cycle (i.e., a cycle in which corifollitropin alfa was administered for ovarian stimulation), participants could continue with a maximum of three FTET cycles before starting the following treatment cycle. A spontaneous pregnancy is a pregnancy that was not considered to have resulted from ET in a treatment cycle or FTET cycle.
Time Frame Up to approximately 26 months after first dose of corifollitropin alfa
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received corifollitropin alfa
Arm/Group Title Corifollitropin Alfa 150 µg
Hide Arm/Group Description:
Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
Overall Number of Participants Analyzed 682
Measure Type: Number
Unit of Measure: percentage of participants
50.6
55.Secondary Outcome
Title Serum Follicle Stimulating Hormone (FSH) Levels in Treatment Cycle 1
Hide Description Blood samples for assessment of serum FSH were taken pre-dose (Stimulation Day 1), Stimulation Day 5 or 6 (prior to first GnRH antagonist administration), Stimulation Day 8, day of (rec)hCG administration, day of ET and 2 weeks after ET.
Time Frame Pre-dose (Stimulation Day 1) through 2 weeks after ET in Treatment Cycle 1
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received corifollitropin alfa and (rec)hCG injection in Treatment Cycle 1
Arm/Group Title Corifollitropin Alfa 150 µg
Hide Arm/Group Description:
Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
Overall Number of Participants Analyzed 658
Mean (Standard Deviation)
Unit of Measure: International Units (IU)/L
Stimulation Day 1 (pre-dose) (n=651) 7.18  (2.34)
Stimulation Day 5 or 6 (n=648) 24.00  (6.36)
Stimulation Day 8 (n=634) 13.23  (3.40)
Day of (rec)hCG injection (n=643) 13.63  (3.69)
Day of embryo transfer (n=593) 3.21  (1.68)
2 weeks after embryo transfer (n=611) 4.84  (3.51)
56.Secondary Outcome
Title Serum FSH Levels in Treatment Cycle 2
Hide Description Blood samples for assessment of serum FSH were taken pre-dose (Stimulation Day 1), Stimulation Day 5 or 6 (prior to first GnRH antagonist administration), Stimulation Day 8, day of (rec)hCG administration, day of ET and 2 weeks after ET.
Time Frame Pre-dose (Stimulation Day 1) through 2 weeks after ET in Treatment Cycle 2
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received corifollitropin alfa and (rec)hCG injection in Treatment Cycle 2
Arm/Group Title Corifollitropin Alfa 150 µg
Hide Arm/Group Description:
Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
Overall Number of Participants Analyzed 364
Mean (Standard Deviation)
Unit of Measure: IU/L
Stimulation Day 1 (pre-dose) (n=357) 7.17  (2.17)
Stimulation Day 5 or 6 (n=358) 24.24  (5.75)
Stimulation Day 8 (n=346) 13.38  (3.35)
Day of (rec)hCG injection (n=358) 13.78  (3.74)
Day of embryo transfer (n=326) 3.20  (1.45)
2 weeks after embryo transfer (n=333) 5.07  (3.33)
57.Secondary Outcome
Title Serum FSH Levels in Treatment Cycle 3
Hide Description Blood samples for assessment of serum FSH were taken pre-dose (Stimulation Day 1), Stimulation Day 5 or 6 (prior to first GnRH antagonist administration), Stimulation Day 8, day of (rec)hCG administration, day of ET and 2 weeks after ET.
Time Frame Pre-dose (Stimulation Day 1) through 2 weeks after ET in Treatment Cycle 3
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received corifollitropin alfa and (rec)hCG injection in Treatment Cycle 3
Arm/Group Title Corifollitropin Alfa 150 µg
Hide Arm/Group Description:
Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
Overall Number of Participants Analyzed 190
Mean (Standard Deviation)
Unit of Measure: IU/L
Stimulation Day 1 (pre-dose) (n=185) 7.50  (5.24)
Stimulation Day 5 or 6 (n=186) 24.51  (5.93)
Stimulation Day 8 (n=184) 13.56  (3.35)
Day of (rec)hCG injection (n=183) 13.62  (3.49)
Day of embryo transfer (n=168) 3.17  (1.55)
2 weeks after embryo transfer (n=173) 5.01  (3.40)
58.Secondary Outcome
Title Serum Luteinizing Hormone (LH) Levels in Treatment Cycle 1
Hide Description Blood samples for assessment of serum LH were taken pre-dose (Stimulation Day 1), Stimulation Day 5 or 6 (prior to first GnRH antagonist administration), Stimulation Day 8, day of (rec)hCG administration, day of ET and 2 weeks after ET.
Time Frame Pre-dose (Stimulation Day 1) through 2 weeks after ET in Treatment Cycle 1
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received corifollitropin alfa and (rec)hCG injection in Treatment Cycle 1
Arm/Group Title Corifollitropin Alfa 150 µg
Hide Arm/Group Description:
Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
Overall Number of Participants Analyzed 658
Mean (Standard Deviation)
Unit of Measure: IU/L
Stimulation Day 1 (pre-dose) (n=651) 5.07  (1.86)
Stimulation Day 5 or 6 (n=648) 4.86  (5.39)
Stimulation Day 8 (n=634) 1.34  (1.55)
Day of (rec)hCG injection (n=643) 1.53  (1.98)
Day of embryo transfer (n=593) NA [1]   (NA)
2 weeks after embryo transfer (n=611) 3.27  (2.57)
[1]
If more than 1/3 of the values per assessment day were smaller than the lower limit of quantitation (LLOQ) of the analytical method (0.6 IU/L), mean and SD are reported as missing.
59.Secondary Outcome
Title Serum LH Levels in Treatment Cycle 2
Hide Description Blood samples for assessment of serum LH were taken pre-dose (Stimulation Day 1), Stimulation Day 5 or 6 (prior to first GnRH antagonist administration), Stimulation Day 8, day of (rec)hCG administration, day of ET and 2 weeks after ET.
Time Frame Pre-dose (Stimulation Day 1) through 2 weeks after ET in Treatment Cycle 2
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received corifollitropin alfa and (rec)hCG injection in Treatment Cycle 2
Arm/Group Title Corifollitropin Alfa 150 µg
Hide Arm/Group Description:
Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
Overall Number of Participants Analyzed 364
Mean (Standard Deviation)
Unit of Measure: IU/L
Stimulation Day 1 (pre-dose) (n=357) 5.13  (1.86)
Stimulation Day 5 or 6 (n=358) 4.78  (5.18)
Stimulation Day 8 (n=346) 1.35  (1.77)
Day of (rec)hCG injection (n=358) 1.67  (2.15)
Day of embryo transfer (n=326) NA [1]   (NA)
2 weeks after embryo transfer (n=333) 3.41  (2.48)
[1]
If more than 1/3 of the values per assessment day were smaller than the LLOQ of the analytical method (0.6 IU/L), mean and SD are reported as missing.
60.Secondary Outcome
Title Serum LH Levels in Treatment Cycle 3
Hide Description Blood samples for assessment of serum LH were taken pre-dose (Stimulation Day 1), Stimulation Day 5 or 6 (prior to first GnRH antagonist administration), Stimulation Day 8, day of (rec)hCG administration, day of ET and 2 weeks after ET.
Time Frame Pre-dose (Stimulation Day 1) through 2 weeks after ET in Treatment Cycle 3
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received corifollitropin alfa and (rec)hCG injection in Treatment Cycle 3
Arm/Group Title Corifollitropin Alfa 150 µg
Hide Arm/Group Description:
Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
Overall Number of Participants Analyzed 190
Mean (Standard Deviation)
Unit of Measure: IU/L
Stimulation Day 1 (pre-dose) (n=185) 5.05  (1.97)
Stimulation Day 5 or 6 (n=186) 4.84  (5.39)
Stimulation Day 8 (n=184) 1.36  (1.50)
Day of (rec)hCG injection (n=183) 1.79  (2.71)
Day of embryo transfer (n=168) NA [1]   (NA)
2 weeks after embryo transfer (n=173) 3.57  (3.13)
[1]
If more than 1/3 of the values per assessment day were smaller than the LLOQ of the analytical method (0.6 IU/L), mean and SD are reported as missing.
61.Secondary Outcome
Title Serum Estradiol Levels in Treatment Cycle 1
Hide Description Blood samples for assessment of serum estradiol were taken pre-dose (Stimulation Day 1), Stimulation Day 5 or 6 (prior to first GnRH antagonist administration), Stimulation Day 8, day of (rec)hCG administration, day of ET and 2 weeks after ET.
Time Frame Pre-dose (Stimulation Day 1) through 2 weeks after ET in Treatment Cycle 1
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received corifollitropin alfa and (rec)hCG injection in Treatment Cycle 1
Arm/Group Title Corifollitropin Alfa 150 µg
Hide Arm/Group Description:
Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
Overall Number of Participants Analyzed 658
Mean (Standard Deviation)
Unit of Measure: pmol/L
Stimulation Day 1 (pre-dose) (n=651) 126.07  (74.36)
Stimulation Day 5 or 6 (n=648) 2246.72  (1479.01)
Stimulation Day 8 (n=633) 3224.72  (2013.62)
Day of (rec)hCG injection (n=642) 5602.90  (3400.47)
Day of embryo transfer (n=593) 2972.22  (1758.83)
2 weeks after embryo transfer (n=611) 1064.92  (2006.31)
62.Secondary Outcome
Title Serum Estradiol Levels in Treatment Cycle 2
Hide Description Blood samples for assessment of serum estradiol were taken pre-dose (Stimulation Day 1), Stimulation Day 5 or 6 (prior to first GnRH antagonist administration), Stimulation Day 8, day of (rec)hCG administration, day of ET and 2 weeks after ET.
Time Frame Pre-dose (Stimulation Day 1) through 2 weeks after ET in Treatment Cycle 2
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received corifollitropin alfa and (rec)hCG injection in Treatment Cycle 2
Arm/Group Title Corifollitropin Alfa 150 µg
Hide Arm/Group Description:
Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
Overall Number of Participants Analyzed 364
Mean (Standard Deviation)
Unit of Measure: pmol/L
Stimulation Day 1 (pre-dose) (n=357) 120.80  (43.73)
Stimulation Day 5 or 6 (n=357) 2116.13  (1362.31)
Stimulation Day 8 (n=346) 3197.12  (2098.53)
Day of (rec)hCG injection (n=358) 5444.89  (2992.37)
Day of embryo transfer (n=324) 2988.11  (1823.81)
2 weeks after embryo transfer (n=333) 929.24  (1861.04)
63.Secondary Outcome
Title Serum Estradiol Levels in Treatment Cycle 3
Hide Description Blood samples for assessment of serum estradiol were taken pre-dose (Stimulation Day 1), Stimulation Day 5 or 6 (prior to first GnRH antagonist administration), Stimulation Day 8, day of (rec)hCG administration, day of ET and 2 weeks after ET.
Time Frame Pre-dose (Stimulation Day 1) through 2 weeks after ET in Treatment Cycle 3
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received corifollitropin alfa and (rec)hCG injection in Treatment Cycle 3
Arm/Group Title Corifollitropin Alfa 150 µg
Hide Arm/Group Description:
Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
Overall Number of Participants Analyzed 190
Mean (Standard Deviation)
Unit of Measure: pmol/L
Stimulation Day 1 (pre-dose) (n=185) 117.5  (42.10)
Stimulation Day 5 or 6 (n=185) 1993.66  (1372.67)
Stimulation Day 8 (n=184) 3164.08  (2214.33)
Day of (rec)hCG injection (n=183) 5605.89  (3687.99)
Day of embryo transfer (n=168) 3065.47  (1988.36)
2 weeks after embryo transfer (n=172) 746.52  (1249.66)
64.Secondary Outcome
Title Serum Progesterone Levels in Treatment Cycle 1
Hide Description Blood samples for assessment of serum progesterone were taken pre-dose (Stimulation Day 1), Stimulation Day 5 or 6 (prior to first GnRH antagonist administration), Stimulation Day 8, day of (rec)hCG administration, day of ET and 2 weeks after ET.
Time Frame Pre-dose (Stimulation Day 1) through 2 weeks after ET in Treatment Cycle 1
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received corifollitropin alfa and (rec)hCG injection in Treatment Cycle 1
Arm/Group Title Corifollitropin Alfa 150 µg
Hide Arm/Group Description:
Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
Overall Number of Participants Analyzed 658
Mean (Standard Deviation)
Unit of Measure: nmol/L
Stimulation Day 1 (pre-dose) (n=651) 1.99  (2.40)
Stimulation Day 5 or 6 (n=648) 2.72  (11.85)
Stimulation Day 8 (n=633) 1.85  (2.00)
Day of (rec)hCG injection (n=643) 4.14  (23.37)
Day of embryo transfer (n=593) 331.16  (169.05)
2 weeks after embryo transfer (n=611) 100.31  (168.53)
65.Secondary Outcome
Title Serum Progesterone Levels in Treatment Cycle 2
Hide Description Blood samples for assessment of serum progesterone were taken pre-dose (Stimulation Day 1), Stimulation Day 5 or 6 (prior to first GnRH antagonist administration), Stimulation Day 8, day of (rec)hCG administration, day of ET and 2 weeks after ET.
Time Frame Pre-dose (Stimulation Day 1) through 2 weeks after ET in Treatment Cycle 2
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received corifollitropin alfa and (rec)hCG injection in Treatment Cycle 2
Arm/Group Title Corifollitropin Alfa 150 µg
Hide Arm/Group Description:
Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
Overall Number of Participants Analyzed 364
Mean (Standard Deviation)
Unit of Measure: nmol/L
Stimulation Day 1 (pre-dose) (n=357) 1.84  (1.64)
Stimulation Day 5 or 6 (n=358) 2.14  (1.13)
Stimulation Day 8 (n=346) 1.75  (1.09)
Day of (rec)hCG injection (n=358) 3.91  (9.14)
Day of embryo transfer (n=325) 316.28  (174.25)
2 weeks after embryo transfer (n=333) 88.21  (165.39)
66.Secondary Outcome
Title Serum Progesterone Levels in Treatment Cycle 3
Hide Description Blood samples for assessment of serum progesterone were taken pre-dose (Stimulation Day 1), Stimulation Day 5 or 6 (prior to first GnRH antagonist administration), Stimulation Day 8, day of (rec)hCG administration, day of ET and 2 weeks after ET.
Time Frame Pre-dose (Stimulation Day 1) through 2 weeks after ET in Treatment Cycle 3
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received corifollitropin alfa and (rec)hCG injection in Treatment Cycle 3
Arm/Group Title Corifollitropin Alfa 150 µg
Hide Arm/Group Description:
Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
Overall Number of Participants Analyzed 190
Mean (Standard Deviation)
Unit of Measure: nmol/L
Stimulation Day 1 (pre-dose) (n=185) 1.76  (0.74)
Stimulation Day 5 or 6 (n=186) 2.29  (3.37)
Stimulation Day 8 (n=184) 1.75  (0.74)
Day of (rec)hCG injection (n=183) 4.92  (14.81)
Day of embryo transfer (n=168) 311.64  (161.71)
2 weeks after embryo transfer (n=173) 79.03  (136.60)
67.Secondary Outcome
Title Serum Inhibin-B Levels in Treatment Cycle 1
Hide Description Blood samples for assessment of serum inhibin-B were taken pre-dose (Stimulation Day 1), Stimulation Day 5 or 6 (prior to first GnRH antagonist administration), Stimulation Day 8, day of (rec)hCG administration, day of ET and 2 weeks after ET.
Time Frame Pre-dose (Stimulation Day 1) through 2 weeks after ET in Treatment Cycle 1
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received corifollitropin alfa and (rec)hCG injection in Treatment Cycle 1
Arm/Group Title Corifollitropin Alfa 150 µg
Hide Arm/Group Description:
Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
Overall Number of Participants Analyzed 658
Mean (Standard Deviation)
Unit of Measure: pg/mL
Stimulation Day 1 (pre-dose) (n=652) 48.22  (29.91)
Stimulation Day 5 or 6 (n=648) 409.63  (299.19)
Stimulation Day 8 (n=634) 455.46  (372.09)
Day of (rec)hCG injection (n=643) 523.07  (464.36)
Day of embryo transfer (n=591) NA [1]   (NA)
2 weeks after embryo transfer (n=611) NA [1]   (NA)
[1]
If more than 1/3 of the values per assessment day were smaller than the LLOQ of the analytical method (10 pg/mL), mean and SD are reported as missing.
68.Secondary Outcome
Title Serum Inhibin-B Levels in Treatment Cycle 2
Hide Description Blood samples for assessment of serum inhibin-B were taken pre-dose (Stimulation Day 1), Stimulation Day 5 or 6 (prior to first GnRH antagonist administration), Stimulation Day 8, day of (rec)hCG administration, day of ET and 2 weeks after ET.
Time Frame Pre-dose (Stimulation Day 1) through 2 weeks after ET in Treatment Cycle 2
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received corifollitropin alfa and (rec)hCG injection in Treatment Cycle 2
Arm/Group Title Corifollitropin Alfa 150 µg
Hide Arm/Group Description:
Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
Overall Number of Participants Analyzed 364
Mean (Standard Deviation)
Unit of Measure: pg/mL
Stimulation Day 1 (pre-dose) (n=356) 48.88  (26.79)
Stimulation Day 5 or 6 (n=358) 406.29  (326.64)
Stimulation Day 8 (n=346) 443.32  (402.67)
Day of (rec)hCG injection (n=358) 505.02  (432.96)
Day of embryo transfer (n=325) 29.38  (34.99)
2 weeks after embryo transfer (n=333) 39.04  (33.74)
69.Secondary Outcome
Title Serum Inhibin-B Levels in Treatment Cycle 3
Hide Description Blood samples for assessment of serum inhibin-B were taken pre-dose (Stimulation Day 1), Stimulation Day 5 or 6 (prior to first GnRH antagonist administration), Stimulation Day 8, day of (rec)hCG administration, day of ET and 2 weeks after ET.
Time Frame Pre-dose (Stimulation Day 1) through 2 weeks after ET in Treatment Cycle 3
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received corifollitropin alfa and (rec)hCG injection in Treatment Cycle 3
Arm/Group Title Corifollitropin Alfa 150 µg
Hide Arm/Group Description:
Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
Overall Number of Participants Analyzed 190
Mean (Standard Deviation)
Unit of Measure: pg/mL
Stimulation Day 1 (pre-dose) (n=185) 50.49  (28.25)
Stimulation Day 5 or 6 (n=186) 406.14  (331.91)
Stimulation Day 8 (n=184) 439.83  (374.99)
Day of (rec)hCG injection (n=183) 504.03  (437.68)
Day of embryo transfer (n=168) 26.28  (25.03)
2 weeks after embryo transfer (n=173) 40.16  (34.05)
Time Frame Up to approximately 26 months after first dose of corifollitropin alfa
Adverse Event Reporting Description SAEs that occurred in fetuses or infants during the study period are included in the summary of SAEs, and are allocated to the associated study participant who was administered corifollitropin alfa.
 
Arm/Group Title Corifollitropin Alfa 150 µg
Hide Arm/Group Description Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
All-Cause Mortality
Corifollitropin Alfa 150 µg
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Corifollitropin Alfa 150 µg
Affected / at Risk (%) # Events
Total   51/682 (7.48%)    
Congenital, familial and genetic disorders   
Autosomal chromosome anomaly  1  1/682 (0.15%)  2
Congenital arterial malformation  1  1/682 (0.15%)  1
Congenital uterine anomaly  1  1/682 (0.15%)  1
Cytogenetic abnormality  1  1/682 (0.15%)  1
Ectopia cordis  1  1/682 (0.15%)  1
Encephalocele  1  1/682 (0.15%)  1
Trisomy 15  1  1/682 (0.15%)  1
Eye disorders   
Conjunctivitis  1  1/682 (0.15%)  1
Gastrointestinal disorders   
Abdominal pain  1  1/682 (0.15%)  1
Peritoneal haemorrhage  1  1/682 (0.15%)  1
Hepatobiliary disorders   
Cholelithiasis  1  1/682 (0.15%)  1
Infections and infestations   
Appendicitis  1  1/682 (0.15%)  1
Post procedural infection  1  1/682 (0.15%)  1
Pyelonephritis  1  1/682 (0.15%)  1
Respiratory tract infection viral  1  1/682 (0.15%)  1
Injury, poisoning and procedural complications   
Head injury  1  1/682 (0.15%)  1
Musculoskeletal and connective tissue disorders   
Growth retardation  1  1/682 (0.15%)  1
Intervertebral disc protrusion  1  1/682 (0.15%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Teratoma  1  1/682 (0.15%)  1
Uterine leiomyoma  1  2/682 (0.29%)  2
Pregnancy, puerperium and perinatal conditions   
Abortion missed  1  3/682 (0.44%)  3
Abortion spontaneous  1  2/682 (0.29%)  2
Abortion threatened  1  1/682 (0.15%)  1
Arrested labour  1  1/682 (0.15%)  1
Breech presentation  1  1/682 (0.15%)  1
Ectopic pregnancy  1  8/682 (1.17%)  8
Foetal distress syndrome  1  1/682 (0.15%)  1
Heterotopic pregnancy  1  1/682 (0.15%)  1
Hyperemesis gravidarum  1  2/682 (0.29%)  2
Imminent abortion  1  2/682 (0.29%)  2
Placenta praevia haemorrhage  1  1/682 (0.15%)  1
Premature baby  1  3/682 (0.44%)  5
Premature labour  1  2/682 (0.29%)  2
Premature rupture of membranes  1  2/682 (0.29%)  2
Retroplacental haematoma  1  1/682 (0.15%)  1
Ruptured ectopic pregnancy  1  2/682 (0.29%)  2
Small for dates baby  1  1/682 (0.15%)  1
Twin pregnancy  1  1/682 (0.15%)  1
Psychiatric disorders   
Psychosomatic disease  1  1/682 (0.15%)  1
Reproductive system and breast disorders   
Endometriosis  1  2/682 (0.29%)  2
Fallopian tube disorder  1  1/682 (0.15%)  1
Ovarian haematoma  1  1/682 (0.15%)  1
Ovarian hyperstimulation syndrome  1  10/682 (1.47%)  10
Pelvic pain  1  1/682 (0.15%)  1
Uterine cervix stenosis  1  1/682 (0.15%)  1
Respiratory, thoracic and mediastinal disorders   
Pulmonary embolism  1  1/682 (0.15%)  1
Surgical and medical procedures   
Gastric stapling reversal  1  1/682 (0.15%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Corifollitropin Alfa 150 µg
Affected / at Risk (%) # Events
Total   239/682 (35.04%)    
Injury, poisoning and procedural complications   
Procedural pain  1  121/682 (17.74%)  163
Nervous system disorders   
Headache  1  62/682 (9.09%)  91
Pregnancy, puerperium and perinatal conditions   
Abortion spontaneous  1  48/682 (7.04%)  51
Reproductive system and breast disorders   
Pelvic discomfort  1  35/682 (5.13%)  39
Pelvic pain  1  51/682 (7.48%)  60
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Publications must be based on data validated and released by the Sponsor. Any scientific paper, presentation, or other communication concerning the study must first be submitted to the Sponsor, at least 6 weeks prior to estimated publication or presentation, for written consent. Sponsor has the right to make its consent conditional upon proper representation of the interpretation of both the Sponsor and the Investigator in the discussion of the data in such communications.
Results Point of Contact
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00696878     History of Changes
Other Study ID Numbers: P05714
MK-8962-007 ( Other Identifier: Merck Study Number )
38825 ( Other Identifier: Merck Study Number )
2004-004966-34 ( EudraCT Number )
First Submitted: June 11, 2008
First Posted: June 13, 2008
Results First Submitted: April 6, 2015
Results First Posted: April 23, 2015
Last Update Posted: September 3, 2018