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Analysis of Two Therapeutic With Cetrotide® in Polycystic Ovarian (PCO) Women in Assisted Reproductive Technology (ART) (ATTAC-PCO)

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ClinicalTrials.gov Identifier: NCT01185704
Recruitment Status : Completed
First Posted : August 20, 2010
Results First Posted : July 3, 2013
Last Update Posted : February 13, 2014
Sponsor:
Collaborator:
Merck Serono S.A.S, France
Information provided by (Responsible Party):
Merck KGaA, Darmstadt, Germany

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Polycystic Ovarian Syndrome
Interventions Drug: Cetrorelix acetate
Drug: Recombinant Human Choriogonadotropin (r-hCG)
Drug: Recombinant human follicle stimulating hormone (r-hFSH)
Enrollment 136
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Day 1 Protocol Day 7 Protocol
Hide Arm/Group Description Cetrotide® 0.25 milligram (mg) was administered subcutaneously once daily from Day 1 (Day 0 of stimulation period [S0]) along with Recombinant human follicle stimulating hormone (r-hFSH) at a dose between 75 and 187.5 international unit (IU) subcutaneously once daily from Day 2 (Day 1 of stimulation period [S1]) until recombinant human chorionic gonadotropin (r-hCG) administration day (at least 2 follicles greater than or equal to (>=) 17 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously. Cetrotide® 0.25 mg was administered subcutaneously once daily from Day 7 (Day 6 of stimulation period [S6]) along with r-hFSH at a dose between 75 and 187.5 IU subcutaneously once daily from Day 2 (S1) until r-hCG administration day (at least 2 follicles >= 19 mm). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
Period Title: Overall Study
Started 68 68
Treated 65 65
Completed 55 60
Not Completed 13 8
Reason Not Completed
Randomized but not treated             3             3
Lack of ovarian response             5             1
Ovarian hyperstimulation syndrome risk             5             3
Ectopic pregnancy             0             1
Arm/Group Title Day 1 Protocol Day 7 Protocol Total
Hide Arm/Group Description Cetrotide® 0.25 milligram (mg) was administered subcutaneously once daily from Day 1 (Day 0 of stimulation period [S0]) along with Recombinant human follicle stimulating hormone (r-hFSH) at a dose between 75 and 187.5 international unit (IU) subcutaneously once daily from Day 2 (Day 1 of stimulation period [S1]) until recombinant human chorionic gonadotropin (r-hCG) administration day (at least 2 follicles greater than or equal to (>=) 17 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously. Cetrotide® 0.25 mg was administered subcutaneously once daily from Day 7 (Day 6 of stimulation period [S6]) along with r-hFSH at a dose between 75 and 187.5 IU subcutaneously once daily from Day 2 (S1) until r-hCG administration day (at least 2 follicles >= 19 mm). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously. Total of all reporting groups
Overall Number of Baseline Participants 65 65 130
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 65 participants 65 participants 130 participants
29.7  (2.9) 29.7  (3.3) 29.7  (3.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 65 participants 65 participants 130 participants
Female
65
 100.0%
65
 100.0%
130
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Estradiol (E2) Levels on r-hCG Day
Hide Description [Not Specified]
Time Frame r-hCG day (end of stimulation cycle [approximately 15 days])
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat (ITT) population included all randomized participants who had received at least 1 dose of the study medication. N" (number of participants analyzed) signifies those participants who were evaluable for this measure.
Arm/Group Title Day 1 Protocol Day 7 Protocol
Hide Arm/Group Description:
Cetrotide® 0.25 milligram (mg) was administered subcutaneously once daily from Day 1 (Day 0 of stimulation period [S0]) along with Recombinant human follicle stimulating hormone (r-hFSH) at a dose between 75 and 187.5 international unit (IU) subcutaneously once daily from Day 2 (Day 1 of stimulation period [S1]) until recombinant human chorionic gonadotropin (r-hCG) administration day (at least 2 follicles greater than or equal to (>=) 17 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
Cetrotide® 0.25 mg was administered subcutaneously once daily from Day 7 (Day 6 of stimulation period [S6]) along with r-hFSH at a dose between 75 and 187.5 IU subcutaneously once daily from Day 2 (S1) until r-hCG administration day (at least 2 follicles >= 19 mm). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
Overall Number of Participants Analyzed 58 62
Mean (Standard Deviation)
Unit of Measure: picogram/milliliter (pg/mL)
1668.86  (862.62) 1672.80  (835.49)
2.Secondary Outcome
Title Serum Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH) Levels
Hide Description [Not Specified]
Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants who had received at least 1 dose of the study medication. N" (number of participants analyzed) signifies those participants who were evaluable for this measure. Here "n" signifies those participants who were evaluated for specified category.
Arm/Group Title Day 1 Protocol Day 7 Protocol
Hide Arm/Group Description:
Cetrotide® 0.25 milligram (mg) was administered subcutaneously once daily from Day 1 (Day 0 of stimulation period [S0]) along with Recombinant human follicle stimulating hormone (r-hFSH) at a dose between 75 and 187.5 international unit (IU) subcutaneously once daily from Day 2 (Day 1 of stimulation period [S1]) until recombinant human chorionic gonadotropin (r-hCG) administration day (at least 2 follicles greater than or equal to (>=) 17 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
Cetrotide® 0.25 mg was administered subcutaneously once daily from Day 7 (Day 6 of stimulation period [S6]) along with r-hFSH at a dose between 75 and 187.5 IU subcutaneously once daily from Day 2 (S1) until r-hCG administration day (at least 2 follicles >= 19 mm). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
Overall Number of Participants Analyzed 58 62
Mean (Standard Deviation)
Unit of Measure: International unit/liter (IU/L)
LH levels (n=58, 62) 4.87  (4.62) 6.84  (3.99)
FSH levels (n=57, 59) 4.98  (1.54) 6.69  (10.29)
3.Secondary Outcome
Title Serum Estradiol (E2) Levels
Hide Description [Not Specified]
Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants who had received at least 1 dose of the study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
Arm/Group Title Day 1 Protocol Day 7 Protocol
Hide Arm/Group Description:
Cetrotide® 0.25 milligram (mg) was administered subcutaneously once daily from Day 1 (Day 0 of stimulation period [S0]) along with Recombinant human follicle stimulating hormone (r-hFSH) at a dose between 75 and 187.5 international unit (IU) subcutaneously once daily from Day 2 (Day 1 of stimulation period [S1]) until recombinant human chorionic gonadotropin (r-hCG) administration day (at least 2 follicles greater than or equal to (>=) 17 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
Cetrotide® 0.25 mg was administered subcutaneously once daily from Day 7 (Day 6 of stimulation period [S6]) along with r-hFSH at a dose between 75 and 187.5 IU subcutaneously once daily from Day 2 (S1) until r-hCG administration day (at least 2 follicles >= 19 mm). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
Overall Number of Participants Analyzed 60 63
Mean (Standard Deviation)
Unit of Measure: pg/mL
30.42  (14.06) 68.79  (116.09)
4.Secondary Outcome
Title Serum Progesterone (P4) Levels
Hide Description [Not Specified]
Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants who had received at least 1 dose of the study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
Arm/Group Title Day 1 Protocol Day 7 Protocol
Hide Arm/Group Description:
Cetrotide® 0.25 milligram (mg) was administered subcutaneously once daily from Day 1 (Day 0 of stimulation period [S0]) along with Recombinant human follicle stimulating hormone (r-hFSH) at a dose between 75 and 187.5 international unit (IU) subcutaneously once daily from Day 2 (Day 1 of stimulation period [S1]) until recombinant human chorionic gonadotropin (r-hCG) administration day (at least 2 follicles greater than or equal to (>=) 17 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
Cetrotide® 0.25 mg was administered subcutaneously once daily from Day 7 (Day 6 of stimulation period [S6]) along with r-hFSH at a dose between 75 and 187.5 IU subcutaneously once daily from Day 2 (S1) until r-hCG administration day (at least 2 follicles >= 19 mm). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
Overall Number of Participants Analyzed 59 62
Mean (Standard Deviation)
Unit of Measure: nanomolar/liter (nmol/L)
0.83  (0.72) 0.97  (1.82)
5.Secondary Outcome
Title Anti Mullerian Hormone (AMH) Levels
Hide Description [Not Specified]
Time Frame Day 0
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants who had received at least 1 dose of the study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
Arm/Group Title Day 1 Protocol Day 7 Protocol
Hide Arm/Group Description:
Cetrotide® 0.25 milligram (mg) was administered subcutaneously once daily from Day 1 (Day 0 of stimulation period [S0]) along with Recombinant human follicle stimulating hormone (r-hFSH) at a dose between 75 and 187.5 international unit (IU) subcutaneously once daily from Day 2 (Day 1 of stimulation period [S1]) until recombinant human chorionic gonadotropin (r-hCG) administration day (at least 2 follicles greater than or equal to (>=) 17 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
Cetrotide® 0.25 mg was administered subcutaneously once daily from Day 7 (Day 6 of stimulation period [S6]) along with r-hFSH at a dose between 75 and 187.5 IU subcutaneously once daily from Day 2 (S1) until r-hCG administration day (at least 2 follicles >= 19 mm). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
Overall Number of Participants Analyzed 63 64
Mean (Standard Deviation)
Unit of Measure: nanogram/milliliter (ng/mL)
6.27  (4.40) 7.18  (4.11)
6.Secondary Outcome
Title Number of Follicles Greater Than or Equal (>=) to 17 mm (For Day 1 Protocol) or 19 mm (For Day 7 Protocol) on r-hCG Day
Hide Description [Not Specified]
Time Frame r-hCG day (end of stimulation cycle [approximately 15 days])
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants who had received at least 1 dose of the study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
Arm/Group Title Day 1 Protocol Day 7 Protocol
Hide Arm/Group Description:
Cetrotide® 0.25 milligram (mg) was administered subcutaneously once daily from Day 1 (Day 0 of stimulation period [S0]) along with Recombinant human follicle stimulating hormone (r-hFSH) at a dose between 75 and 187.5 international unit (IU) subcutaneously once daily from Day 2 (Day 1 of stimulation period [S1]) until recombinant human chorionic gonadotropin (r-hCG) administration day (at least 2 follicles greater than or equal to (>=) 17 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
Cetrotide® 0.25 mg was administered subcutaneously once daily from Day 7 (Day 6 of stimulation period [S6]) along with r-hFSH at a dose between 75 and 187.5 IU subcutaneously once daily from Day 2 (S1) until r-hCG administration day (at least 2 follicles >= 19 mm). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
Overall Number of Participants Analyzed 58 61
Mean (Standard Deviation)
Unit of Measure: follicles
3.55  (2.20) 2.49  (1.99)
7.Secondary Outcome
Title Number and Quality of Oocytes Retrieved
Hide Description Oocyte retrieval is a technique used in in-vitro fertilization (IVF) in order to remove oocytes from the ovary of the female participant, enabling fertilization outside the body. Oocytes were classified into 4 different categories based on their quality: mature, fractured, immature and inseminated oocytes.
Time Frame Oocytes retrieval day (36 +/- 2 hours post r-hCG day [end of stimulation cycle {approximately 15 days}])
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants who had received at least 1 dose of the study medication.
Arm/Group Title Day 1 Protocol Day 7 Protocol
Hide Arm/Group Description:
Cetrotide® 0.25 milligram (mg) was administered subcutaneously once daily from Day 1 (Day 0 of stimulation period [S0]) along with Recombinant human follicle stimulating hormone (r-hFSH) at a dose between 75 and 187.5 international unit (IU) subcutaneously once daily from Day 2 (Day 1 of stimulation period [S1]) until recombinant human chorionic gonadotropin (r-hCG) administration day (at least 2 follicles greater than or equal to (>=) 17 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
Cetrotide® 0.25 mg was administered subcutaneously once daily from Day 7 (Day 6 of stimulation period [S6]) along with r-hFSH at a dose between 75 and 187.5 IU subcutaneously once daily from Day 2 (S1) until r-hCG administration day (at least 2 follicles >= 19 mm). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
Overall Number of Participants Analyzed 65 65
Mean (Standard Deviation)
Unit of Measure: oocytes
Total number of oocytes 7.48  (5.21) 8.11  (5.55)
Mature oocytes 2.52  (4.07) 3.72  (4.43)
Fractured oocytes 0.09  (0.34) 0.11  (0.44)
Immature oocytes 0.98  (2.29) 1.38  (2.55)
Inseminated oocytes 3.06  (4.14) 4.52  (4.66)
8.Secondary Outcome
Title Total Dose of Recombinant Human Follicle Stimulating Hormone (r-hFSH)
Hide Description [Not Specified]
Time Frame Day 1 up to r-hCG day (end of stimulation cycle [approximately 15 days])
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants who had received at least 1 dose of the study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
Arm/Group Title Day 1 Protocol Day 7 Protocol
Hide Arm/Group Description:
Cetrotide® 0.25 milligram (mg) was administered subcutaneously once daily from Day 1 (Day 0 of stimulation period [S0]) along with Recombinant human follicle stimulating hormone (r-hFSH) at a dose between 75 and 187.5 international unit (IU) subcutaneously once daily from Day 2 (Day 1 of stimulation period [S1]) until recombinant human chorionic gonadotropin (r-hCG) administration day (at least 2 follicles greater than or equal to (>=) 17 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
Cetrotide® 0.25 mg was administered subcutaneously once daily from Day 7 (Day 6 of stimulation period [S6]) along with r-hFSH at a dose between 75 and 187.5 IU subcutaneously once daily from Day 2 (S1) until r-hCG administration day (at least 2 follicles >= 19 mm). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
Overall Number of Participants Analyzed 64 65
Mean (Standard Deviation)
Unit of Measure: international unit (IU)
1462.50  (537.85) 1221.35  (478.31)
9.Secondary Outcome
Title Percentage of Fertilized Oocytes Retrieved
Hide Description Oocytes were fertilized using Intra-cytoplasmic Sperm Injection (ICSI) technique which is an IVF procedure in which a single sperm is injected directly into an egg under a microscope.
Time Frame Oocytes retrieval day (36 +/- 2 hours post r-hCG day [end of stimulation cycle {approximately 15 days}])
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants who had received at least 1 dose of the study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
Arm/Group Title Day 1 Protocol Day 7 Protocol
Hide Arm/Group Description:
Cetrotide® 0.25 milligram (mg) was administered subcutaneously once daily from Day 1 (Day 0 of stimulation period [S0]) along with Recombinant human follicle stimulating hormone (r-hFSH) at a dose between 75 and 187.5 international unit (IU) subcutaneously once daily from Day 2 (Day 1 of stimulation period [S1]) until recombinant human chorionic gonadotropin (r-hCG) administration day (at least 2 follicles greater than or equal to (>=) 17 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
Cetrotide® 0.25 mg was administered subcutaneously once daily from Day 7 (Day 6 of stimulation period [S6]) along with r-hFSH at a dose between 75 and 187.5 IU subcutaneously once daily from Day 2 (S1) until r-hCG administration day (at least 2 follicles >= 19 mm). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
Overall Number of Participants Analyzed 56 61
Mean (Standard Deviation)
Unit of Measure: percent fertilized oocytes
46.22  (30.66) 46.86  (30.54)
10.Secondary Outcome
Title Number of Embryos
Hide Description Embryo is defined as the product of the zygote, two or three days after fertilization of the oocytes.
Time Frame Day 2-3 post oocytes retrieval day (36 +/- 2 hours post r-hCG day [end of stimulation cycle {approximately 15 days}])
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants who had received at least 1 dose of the study medication.
Arm/Group Title Day 1 Protocol Day 7 Protocol
Hide Arm/Group Description:
Cetrotide® 0.25 milligram (mg) was administered subcutaneously once daily from Day 1 (Day 0 of stimulation period [S0]) along with Recombinant human follicle stimulating hormone (r-hFSH) at a dose between 75 and 187.5 international unit (IU) subcutaneously once daily from Day 2 (Day 1 of stimulation period [S1]) until recombinant human chorionic gonadotropin (r-hCG) administration day (at least 2 follicles greater than or equal to (>=) 17 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
Cetrotide® 0.25 mg was administered subcutaneously once daily from Day 7 (Day 6 of stimulation period [S6]) along with r-hFSH at a dose between 75 and 187.5 IU subcutaneously once daily from Day 2 (S1) until r-hCG administration day (at least 2 follicles >= 19 mm). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
Overall Number of Participants Analyzed 65 65
Mean (Standard Deviation)
Unit of Measure: embryos
3.18  (3.18) 3.60  (3.27)
11.Secondary Outcome
Title Number of Blastocysts
Hide Description Blastocyst is an embryo, five or six days after fertilization, with an inner cell mass, outer layer of trophectoderm and a fluid-filled blastocoele cavity.
Time Frame Day 5-6 post oocytes retrieval day (36 +/- 2 hours post r-hCG day [end of stimulation cycle {approximately 15 days}])
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants who had received at least 1 dose of the study medication.
Arm/Group Title Day 1 Protocol Day 7 Protocol
Hide Arm/Group Description:
Cetrotide® 0.25 milligram (mg) was administered subcutaneously once daily from Day 1 (Day 0 of stimulation period [S0]) along with Recombinant human follicle stimulating hormone (r-hFSH) at a dose between 75 and 187.5 international unit (IU) subcutaneously once daily from Day 2 (Day 1 of stimulation period [S1]) until recombinant human chorionic gonadotropin (r-hCG) administration day (at least 2 follicles greater than or equal to (>=) 17 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
Cetrotide® 0.25 mg was administered subcutaneously once daily from Day 7 (Day 6 of stimulation period [S6]) along with r-hFSH at a dose between 75 and 187.5 IU subcutaneously once daily from Day 2 (S1) until r-hCG administration day (at least 2 follicles >= 19 mm). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
Overall Number of Participants Analyzed 65 65
Mean (Standard Deviation)
Unit of Measure: blastocysts
0.26  (1.05) 0.20  (0.90)
12.Secondary Outcome
Title Number of Transferred Embryos
Hide Description Embryo transfer is the procedure in which one or more embryos are placed in the uterus.
Time Frame Day 2-3 post Oocytes retrieval day (36 +/- 2 hours post r-hCG day [end of stimulation cycle {approximately 15 days}])
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants who had received at least 1 dose of the study medication.
Arm/Group Title Day 1 Protocol Day 7 Protocol
Hide Arm/Group Description:
Cetrotide® 0.25 milligram (mg) was administered subcutaneously once daily from Day 1 (Day 0 of stimulation period [S0]) along with Recombinant human follicle stimulating hormone (r-hFSH) at a dose between 75 and 187.5 international unit (IU) subcutaneously once daily from Day 2 (Day 1 of stimulation period [S1]) until recombinant human chorionic gonadotropin (r-hCG) administration day (at least 2 follicles greater than or equal to (>=) 17 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
Cetrotide® 0.25 mg was administered subcutaneously once daily from Day 7 (Day 6 of stimulation period [S6]) along with r-hFSH at a dose between 75 and 187.5 IU subcutaneously once daily from Day 2 (S1) until r-hCG administration day (at least 2 follicles >= 19 mm). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
Overall Number of Participants Analyzed 65 65
Mean (Standard Deviation)
Unit of Measure: transferred embryos
0.95  (0.74) 1.02  (0.74)
13.Secondary Outcome
Title Implantation Rate
Hide Description Implantation rate per reporting group was measured as the number of gestational sacs observed, divided by the number of embryos transferred multiplied by 100.
Time Frame 5 weeks post oocytes retrieval day (36 +/- 2 hours post r-hCG day [end of stimulation cycle {approximately 15 days}])
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants who had received at least 1 dose of the study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
Arm/Group Title Day 1 Protocol Day 7 Protocol
Hide Arm/Group Description:
Cetrotide® 0.25 milligram (mg) was administered subcutaneously once daily from Day 1 (Day 0 of stimulation period [S0]) along with Recombinant human follicle stimulating hormone (r-hFSH) at a dose between 75 and 187.5 international unit (IU) subcutaneously once daily from Day 2 (Day 1 of stimulation period [S1]) until recombinant human chorionic gonadotropin (r-hCG) administration day (at least 2 follicles greater than or equal to (>=) 17 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
Cetrotide® 0.25 mg was administered subcutaneously once daily from Day 7 (Day 6 of stimulation period [S6]) along with r-hFSH at a dose between 75 and 187.5 IU subcutaneously once daily from Day 2 (S1) until r-hCG administration day (at least 2 follicles >= 19 mm). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
Overall Number of Participants Analyzed 46 48
Measure Type: Number
Unit of Measure: percent sacs per embryo
36.90 32.25
14.Secondary Outcome
Title Percentage of Participants With Clinical Pregnancy
Hide Description Clinical pregnancy was defined as pregnancy diagnosed by ultrasonographic visualization of one or more gestational sacs or definitive clinical signs of pregnancy. It excludes ectopic pregnancy.
Time Frame 10 weeks post r-hCG day (end of stimulation cycle [approximately 15 days])
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants who had received at least 1 dose of the study medication.
Arm/Group Title Day 1 Protocol Day 7 Protocol
Hide Arm/Group Description:
Cetrotide® 0.25 milligram (mg) was administered subcutaneously once daily from Day 1 (Day 0 of stimulation period [S0]) along with Recombinant human follicle stimulating hormone (r-hFSH) at a dose between 75 and 187.5 international unit (IU) subcutaneously once daily from Day 2 (Day 1 of stimulation period [S1]) until recombinant human chorionic gonadotropin (r-hCG) administration day (at least 2 follicles greater than or equal to (>=) 17 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
Cetrotide® 0.25 mg was administered subcutaneously once daily from Day 7 (Day 6 of stimulation period [S6]) along with r-hFSH at a dose between 75 and 187.5 IU subcutaneously once daily from Day 2 (S1) until r-hCG administration day (at least 2 follicles >= 19 mm). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
Overall Number of Participants Analyzed 65 65
Measure Type: Number
Unit of Measure: percentage of participants
20 20
15.Secondary Outcome
Title Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Hide Description An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered. A Serious Adverse Event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. To avoid the participant/event combination double-count AEs and SAEs are reported separately.
Time Frame Day 1 up to end of study (15 days post last administration of study drug)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Day 1 Protocol Day 7 Protocol
Hide Arm/Group Description:
Cetrotide® 0.25 milligram (mg) was administered subcutaneously once daily from Day 1 (Day 0 of stimulation period [S0]) along with Recombinant human follicle stimulating hormone (r-hFSH) at a dose between 75 and 187.5 international unit (IU) subcutaneously once daily from Day 2 (Day 1 of stimulation period [S1]) until recombinant human chorionic gonadotropin (r-hCG) administration day (at least 2 follicles greater than or equal to (>=) 17 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
Cetrotide® 0.25 mg was administered subcutaneously once daily from Day 7 (Day 6 of stimulation period [S6]) along with r-hFSH at a dose between 75 and 187.5 IU subcutaneously once daily from Day 2 (S1) until r-hCG administration day (at least 2 follicles >= 19 mm). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
Overall Number of Participants Analyzed 65 65
Measure Type: Number
Unit of Measure: participants
AEs 11 18
SAEs 2 4
Time Frame Day 1 up to end of study (15 days post last administration of study drug)
Adverse Event Reporting Description An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
 
Arm/Group Title Day 1 Protocol Day 7 Protocol
Hide Arm/Group Description Cetrotide® 0.25 milligram (mg) was administered subcutaneously once daily from Day 1 (Day 0 of stimulation period [S0]) along with Recombinant human follicle stimulating hormone (r-hFSH) at a dose between 75 and 187.5 international unit (IU) subcutaneously once daily from Day 2 (Day 1 of stimulation period [S1]) until recombinant human chorionic gonadotropin (r-hCG) administration day (at least 2 follicles greater than or equal to (>=) 17 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously. Cetrotide® 0.25 mg was administered subcutaneously once daily from Day 7 (Day 6 of stimulation period [S6]) along with r-hFSH at a dose between 75 and 187.5 IU subcutaneously once daily from Day 2 (S1) until r-hCG administration day (at least 2 follicles >= 19 mm). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
All-Cause Mortality
Day 1 Protocol Day 7 Protocol
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Day 1 Protocol Day 7 Protocol
Affected / at Risk (%) Affected / at Risk (%)
Total   2/65 (3.08%)   4/65 (6.15%) 
Pregnancy, puerperium and perinatal conditions     
Ectopic pregnancy * 1  0/65 (0.00%)  1/65 (1.54%) 
Reproductive system and breast disorders     
Ovarian Hyperstimulation syndrome * 1  2/65 (3.08%)  3/65 (4.62%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (Unspecified)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Day 1 Protocol Day 7 Protocol
Affected / at Risk (%) Affected / at Risk (%)
Total   9/65 (13.85%)   14/65 (21.54%) 
Gastrointestinal disorders     
Abdominal pain * 1  0/65 (0.00%)  1/65 (1.54%) 
Anal fissure * 1  1/65 (1.54%)  0/65 (0.00%) 
Nausea * 1  2/65 (3.08%)  1/65 (1.54%) 
General disorders     
Injection site erythema * 1  1/65 (1.54%)  1/65 (1.54%) 
Injection site irritation * 1  1/65 (1.54%)  0/65 (0.00%) 
Injection site burning * 1  1/65 (1.54%)  0/65 (0.00%) 
Injection site pruritus * 1  1/65 (1.54%)  1/65 (1.54%) 
Pyrexia * 1  1/65 (1.54%)  0/65 (0.00%) 
Injection site pain * 1  0/65 (0.00%)  1/65 (1.54%) 
Investigations     
Oestradiol increased * 1  1/65 (1.54%)  0/65 (0.00%) 
Nervous system disorders     
Headache * 1  6/65 (9.23%)  1/65 (1.54%) 
Reproductive system and breast disorders     
Ovarian Hyperstimulation syndrome * 1  0/65 (0.00%)  6/65 (9.23%) 
Pelvic pain * 1  4/65 (6.15%)  3/65 (4.62%) 
Metrorrhagia * 1  0/65 (0.00%)  1/65 (1.54%) 
Adnexa uterin pain * 1  1/65 (1.54%)  0/65 (0.00%) 
Vascular disorders     
Hot flush * 1  1/65 (1.54%)  0/65 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (Unspecified)
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.
 
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Merck KGaA Communication Center
Organization: Merck Serono, a division of Merck KGaA
Phone: +49-6151-72-5200
EMail: service@merckgroup.com
Layout table for additonal information
Responsible Party: Merck KGaA, Darmstadt, Germany
ClinicalTrials.gov Identifier: NCT01185704     History of Changes
Other Study ID Numbers: EMR200088-501
2007-007932-25 ( EudraCT Number )
INI 28091 ( Other Identifier: Merck KGaA )
First Submitted: August 10, 2010
First Posted: August 20, 2010
Results First Submitted: March 25, 2013
Results First Posted: July 3, 2013
Last Update Posted: February 13, 2014