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Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established in Clinical Trial P05690 (Care Program) (P05710) (Care)

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ClinicalTrials.gov Identifier: NCT00702624
Recruitment Status : Completed
First Posted : June 20, 2008
Results First Posted : April 30, 2015
Last Update Posted : March 21, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Observational
Study Design Observational Model: Other;   Time Perspective: Prospective
Conditions Pregnancy
Neonates
Interventions Drug: Corifollitropin alfa
Biological: recFSH (follitropin beta)
Drug: gonadatropin releasing hormone (GnRH) antagonist ganirelix
Biological: human chorion gonadotropin (hCG)
Biological: progesterone
Drug: placebo-recFSH (follitropin beta)
Drug: placebo-corifollitropin alfa
Biological: open-label recFSH (follitropin beta)
Enrollment 113
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Corifollitropin Alfa 100 μg Women/Expectant Mothers recFSH 150 IU Women/Expectant Mothers Corifollitropin Alfa 100 μg Fetuses at 10 Weeks After ET recFSH 150 IU Fetuses at 10 Weeks After ET
Hide Arm/Group Description Participants in base study P05690 received single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of menstrual cycle and daily placebo recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including Day of hCG (10,000 or 5,000 IU/USP); and progesterone (at least 600 mg/day vaginally or 50 mg/day by intramuscular [IM] injection), starting on day of OPU and continuing at least 6 weeks or up to menses. Eligible participants from base study were enrolled in follow up study P05710, but no study treatments were given. Participants in the reference group in base study P05690 received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the Day of hCG administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the Day of OPU and continuing for at least 6 weeks or up to menses. Eligible participants from the base study were enrolled in follow up study P05710, but no study treatments were given. This group includes fetuses of expectant mothers who were administered corifollitropin alfa in base study P05690 (NCT00702845). The fetuses were present at 10 weeks after embryo transfer (ET) in the base study, and expectant mothers were eligible for enrollment in follow up study P05710. This group includes fetuses of expectant mothers who were administered recFSH on base study P05690 (NCT00702845). The fetuses were present at 10 weeks after ET in the base study, and expectant mothers were eligible for enrollment in follow up study P05710.
Period Title: Base Study P05690 (NCT00702845)
Started 268 128 0 0
Completed 246 [1] 121 [1] 0 0
Not Completed 22 7 0 0
[1]
To complete study, participants from the base study P05690 (NCT00702845) had embryos transferred.
Period Title: Expectant Mother Follow-up
Started 68 45 0 0
Completed 61 [1] 45 [1] 0 0
Not Completed 7 0 0 0
[1]
To complete the study, participants must have completed a follow-up visit at 4-12 weeks postpartum.
Period Title: Fetuses/Infant Follow-up
Started 0 0 88 55
Live Born Infants 0 0 80 [1] 55 [2]
Completed 0 0 78 [3] 55 [3]
Not Completed 0 0 10 0
[1]
Infants born to eligible mothers were followed for safety and efficacy
[2]
Infants born to eligible mothers were followed for safety and efficacy.
[3]
To complete the study, infants must have completed a follow-up visit at 4-12 weeks postpartum.
Arm/Group Title Corifollitropin Alfa 100 μg Expectant Mothers recFSH 150 IU Expectant Mothers Total
Hide Arm/Group Description Participants in base study P05690 received single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of menstrual cycle and daily placebo recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including Day of hCG (10,000 or 5,000 IU/USP); and progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on day of OPU and continuing at least 6 weeks or up to menses. Eligible participants from base study were enrolled in follow up study P05710, but no study treatments were given. Participants in the reference group in base study P05690 received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the Day of hCG administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the Day of OPU and continuing for at least 6 weeks or up to menses. Eligible participants from the base study were enrolled in follow up study P05710, but no study treatments were given. Total of all reporting groups
Overall Number of Baseline Participants 68 45 113
Hide Baseline Analysis Population Description
Individuals who participated in base study P05690 (NCT00702845) and received at least one dose of either corifollitropin alfa or recFSH, who had an ongoing pregnancy confirmed by ultrasound at least 10 weeks after ET in base study P05690 and were able and willing to give written informed consent.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 68 participants 45 participants 113 participants
30.5  (3.3) 31.3  (3.1) 30.8  (3.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 68 participants 45 participants 113 participants
Female
68
 100.0%
45
 100.0%
113
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Percentage of Women With ≥1 Live Born Infant During Follow-up (Take-Home Baby Rate)
Hide Description The Take-Home Baby Rate was defined as the number of participants with an ongoing pregnancy in base study P05690 with at least one live born infant during follow up relative to the number of participants treated in base study.
Time Frame From approximately 10 weeks after ET in base study P05690 up to birth of infant (up to approximately 6 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) group from base study P05690 (NCT00702845), which consisted of randomized participants who were treated with corifollitropin alfa or recFSH.
Arm/Group Title Corifollitropin Alfa 100 μg Women recFSH 150 IU Women
Hide Arm/Group Description:
Participants in base study P05690 received single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of menstrual cycle and daily placebo recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including Day of hCG (10,000 or 5,000 IU/USP); and progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on day of OPU and continuing at least 6 weeks or up to menses. Eligible participants from base study were enrolled in follow up study P05710, but no study treatments were given.
Participants in the reference group in base study P05690 received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the Day of hCG administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the Day of OPU and continuing for at least 6 weeks or up to menses. Eligible participants from the base study were enrolled in follow up study P05710, but no study treatments were given.
Overall Number of Participants Analyzed 268 128
Measure Type: Number
Unit of Measure: Percentage of participants
23.5 34.4
2.Primary Outcome
Title Number of Expectant Mothers Experiencing Adverse Events (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 From approximately 10 weeks after ET in base study P05690 up to birth of infant (up to approximately 6 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Follow-up safety analysis was performed on expectant mothers who received corifollitropin alfa or recFSH on base study P05690 (NCT00702845) and who enrolled on the follow-up study.
Arm/Group Title Corifollitropin Alfa 100 μg Expectant Mothers recFSH 150 IU Expectant Mothers
Hide Arm/Group Description:
Participants in base study P05690 received single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of menstrual cycle and daily placebo recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including Day of hCG (10,000 or 5,000 IU/USP); and progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on day of OPU and continuing at least 6 weeks or up to menses. Eligible participants from base study were enrolled in follow up study P05710, but no study treatments were given.
Participants in the reference group in base study P05690 received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the Day of hCG administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the Day of OPU and continuing for at least 6 weeks or up to menses. Eligible participants from the base study were enrolled in follow up study P05710, but no study treatments were given.
Overall Number of Participants Analyzed 68 45
Measure Type: Number
Unit of Measure: Participants
48 35
3.Primary Outcome
Title Number of Expectant Mothers Experiencing 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.
Time Frame From approximately 10 weeks after ET in base study P05690 up to birth of infant (up to approximately 6 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Follow-up safety analysis was performed on expectant mothers who received corifollitropin alfa or recFSH on base study P05690 (NCT00702845) and who enrolled on the follow-up study.
Arm/Group Title Corifollitropin Alfa 100 μg Expectant Mothers recFSH 150 IU Expectant Mothers
Hide Arm/Group Description:
Participants in base study P05690 received single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of menstrual cycle and daily placebo recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including Day of hCG (10,000 or 5,000 IU/USP); and progesterone (at least 600 mg/day vaginally or 50 mg/day by intramuscular [IM] injection), starting on day of OPU and continuing at least 6 weeks or up to menses. Eligible participants from base study were enrolled in follow up study P05710, but no study treatments were given.
Participants in the reference group in base study P05690 received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the Day of hCG administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the Day of OPU and continuing for at least 6 weeks or up to menses. Eligible participants from the base study were enrolled in follow up study P05710, but no study treatments were given.
Overall Number of Participants Analyzed 68 45
Measure Type: Number
Unit of Measure: Participants
38 21
4.Primary Outcome
Title Number of Infants Experiencing 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 can 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 12 weeks after birth
Hide Outcome Measure Data
Hide Analysis Population Description
Follow-up safety analysis was performed on live born infants delivered by expectant mothers who received corifollitropin alfa or recFSH on base study P05690 (NCT00702845) and who enrolled on the follow-up study.
Arm/Group Title Corifollitropin Alfa 100 μg Follow-Up Infants recFSH 150 IU Follow-Up Infants
Hide Arm/Group Description:
Infants that were born to eligible mothers who received SC corifollitropin alfa plus hCG on base study P05690 (NCT00702845) were followed for safety and efficacy on the current follow-up study (P05710) according to standard practice.
Infants that were born to eligible mothers who received SC recFSH plus hCG on base study P05690 (NCT00702845) were followed for safety and efficacy on the current follow-up study (P05710) according to standard practice.
Overall Number of Participants Analyzed 80 55
Measure Type: Number
Unit of Measure: Live born infants
37 27
5.Primary Outcome
Title Number of Infants Experiencing 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.
Time Frame Up to 12 weeks after birth
Hide Outcome Measure Data
Hide Analysis Population Description
Follow-up safety analysis was performed on live born infants delivered by expectant mothers who received corifollitropin alfa or recFSH on base study P05690 (NCT00702845) and who enrolled on the follow-up study.
Arm/Group Title Corifollitropin Alfa 100 μg Follow-Up Infants recFSH 150 IU Follow-Up Infants
Hide Arm/Group Description:
Infants that were born to eligible mothers who received SC corifollitropin alfa plus hCG on base study P05690 (NCT00702845) were followed for safety and efficacy on the current follow-up study (P05710) according to standard practice.
Infants that were born to eligible mothers who received SC recFSH plus hCG on base study P05690 (NCT00702845) were followed for safety and efficacy on the current follow-up study (P05710) according to standard practice.
Overall Number of Participants Analyzed 80 55
Measure Type: Number
Unit of Measure: Live born infants
30 16
Time Frame From approximately 10 weeks after ET in base study P05690 (NCT00702845) up to 12 weeks after birth in current follow-up study (up to approximately 9 months)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Corifollitropin Alfa 100 μg Expectant Mothers recFSH 150 IU Expectant Mothers Corifollitropin Alfa 100 μg Fetuses at 10 Weeks After ET recFSH 150 IU Fetuses at 10 Weeks After ET
Hide Arm/Group Description Participants in base study P05690 received single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of menstrual cycle and daily placebo recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including Day of hCG (10,000 or 5,000 IU/USP); and progesterone (at least 600 mg/day vaginally or 50 mg/day by intramuscular [IM] injection), starting on day of OPU and continuing at least 6 weeks or up to menses. Eligible participants from base study were enrolled in follow up study P05710, but no study treatments were given. Participants in the reference group in base study P05690 received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the Day of hCG administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the Day of OPU and continuing for at least 6 weeks or up to menses. Eligible participants from the base study were enrolled in follow up study P05710, but no study treatments were given. This group includes fetuses of expectant mothers who were administered corifollitropin alfa in base study P05690 (NCT00702845). The fetuses were present at 10 weeks after embryo transfer (ET) in the base study, and expectant mothers were eligible for enrollment in follow up study P05710. This group includes fetuses of expectant mothers who were administered recFSH on base study P05690 (NCT00702845). The fetuses were present at 10 weeks after ET in the base study, and expectant mothers were eligible for enrollment in follow up study P05710.
All-Cause Mortality
Corifollitropin Alfa 100 μg Expectant Mothers recFSH 150 IU Expectant Mothers Corifollitropin Alfa 100 μg Fetuses at 10 Weeks After ET recFSH 150 IU Fetuses at 10 Weeks After ET
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Corifollitropin Alfa 100 μg Expectant Mothers recFSH 150 IU Expectant Mothers Corifollitropin Alfa 100 μg Fetuses at 10 Weeks After ET recFSH 150 IU Fetuses at 10 Weeks After ET
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   38/68 (55.88%)      21/45 (46.67%)      31/88 (35.23%)      16/55 (29.09%)    
Blood and lymphatic system disorders         
Thrombocytopenia neonatal  1  0/68 (0.00%)  0 0/45 (0.00%)  0 1/88 (1.14%)  1 1/55 (1.82%)  1
Cardiac disorders         
Mitral valve prolapse  1  1/68 (1.47%)  1 0/45 (0.00%)  0 0/88 (0.00%)  0 0/55 (0.00%)  0
Bradycardia foetal  1  1/68 (1.47%)  1 0/45 (0.00%)  0 0/88 (0.00%)  0 0/55 (0.00%)  0
Tachycardia foetal  1  0/68 (0.00%)  0 1/45 (2.22%)  1 0/88 (0.00%)  0 0/55 (0.00%)  0
Pulmonary valve stenosis  1  0/68 (0.00%)  0 0/45 (0.00%)  0 0/88 (0.00%)  0 1/55 (1.82%)  1
Congenital, familial and genetic disorders         
Aplasia cutis congenita  1  0/68 (0.00%)  0 0/45 (0.00%)  0 1/88 (1.14%)  1 0/55 (0.00%)  0
Atrial septal defect  1  0/68 (0.00%)  0 0/45 (0.00%)  0 0/88 (0.00%)  0 3/55 (5.45%)  3
Congenital infection  1  0/68 (0.00%)  0 0/45 (0.00%)  0 1/88 (1.14%)  1 0/55 (0.00%)  0
Congenital pneumonia  1  0/68 (0.00%)  0 0/45 (0.00%)  0 2/88 (2.27%)  2 0/55 (0.00%)  0
Congenital pulmonary artery anomaly  1  0/68 (0.00%)  0 0/45 (0.00%)  0 1/88 (1.14%)  1 0/55 (0.00%)  0
Congenital pyelocaliectasis  1  0/68 (0.00%)  0 0/45 (0.00%)  0 0/88 (0.00%)  0 2/55 (3.64%)  2
Congenital syphilis  1  0/68 (0.00%)  0 0/45 (0.00%)  0 1/88 (1.14%)  1 0/55 (0.00%)  0
Haemangioma congenital  1  0/68 (0.00%)  0 0/45 (0.00%)  0 1/88 (1.14%)  1 0/55 (0.00%)  0
Patent ductus arteriosus  1  0/68 (0.00%)  0 0/45 (0.00%)  0 2/88 (2.27%)  2 2/55 (3.64%)  2
Pulmonary artery stenosis congenital  1  0/68 (0.00%)  0 0/45 (0.00%)  0 0/88 (0.00%)  0 1/55 (1.82%)  1
Pyloric stenosis  1  0/68 (0.00%)  0 0/45 (0.00%)  0 0/88 (0.00%)  0 1/55 (1.82%)  1
Renal dysplasia  1  0/68 (0.00%)  0 0/45 (0.00%)  0 1/88 (1.14%)  1 0/55 (0.00%)  0
Ventricular septal defect  1  0/68 (0.00%)  0 0/45 (0.00%)  0 0/88 (0.00%)  0 1/55 (1.82%)  1
Eye disorders         
Retinopathy of prematurity  1  0/68 (0.00%)  0 0/45 (0.00%)  0 0/88 (0.00%)  0 1/55 (1.82%)  1
Gastrointestinal disorders         
Dysphagia  1  0/68 (0.00%)  0 0/45 (0.00%)  0 1/88 (1.14%)  1 0/55 (0.00%)  0
General disorders         
Fever neonatal  1  0/68 (0.00%)  0 0/45 (0.00%)  0 1/88 (1.14%)  1 0/55 (0.00%)  0
Oedema neonatal  1  0/68 (0.00%)  0 0/45 (0.00%)  0 1/88 (1.14%)  1 0/55 (0.00%)  0
Hepatobiliary disorders         
Liver disorder  1  0/68 (0.00%)  0 1/45 (2.22%)  1 0/88 (0.00%)  0 0/55 (0.00%)  0
Hyperbilirubinaemia neonatal  1  0/68 (0.00%)  0 0/45 (0.00%)  0 8/88 (9.09%)  8 6/55 (10.91%)  6
Neonatal cholestasis  1  0/68 (0.00%)  0 0/45 (0.00%)  0 1/88 (1.14%)  1 0/55 (0.00%)  0
Infections and infestations         
Intrauterine infection  1  1/68 (1.47%)  1 0/45 (0.00%)  0 0/88 (0.00%)  0 0/55 (0.00%)  0
Tuberculosis  1  1/68 (1.47%)  1 0/45 (0.00%)  0 0/88 (0.00%)  0 0/55 (0.00%)  0
Urinary tract infection bacterial  1  0/68 (0.00%)  0 1/45 (2.22%)  1 0/88 (0.00%)  0 0/55 (0.00%)  0
Oral fungal infection  1  0/68 (0.00%)  0 0/45 (0.00%)  0 0/88 (0.00%)  0 1/55 (1.82%)  1
Pneumonia chlamydial  1  0/68 (0.00%)  0 0/45 (0.00%)  0 1/88 (1.14%)  1 0/55 (0.00%)  0
Pneumonia viral  1  0/68 (0.00%)  0 0/45 (0.00%)  0 0/88 (0.00%)  0 1/55 (1.82%)  1
Pulmonary sepsis  1  0/68 (0.00%)  0 0/45 (0.00%)  0 1/88 (1.14%)  1 0/55 (0.00%)  0
Sepsis neonatal  1  0/68 (0.00%)  0 0/45 (0.00%)  0 1/88 (1.14%)  1 0/55 (0.00%)  0
Staphylococcal infection  1  0/68 (0.00%)  0 0/45 (0.00%)  0 1/88 (1.14%)  1 0/55 (0.00%)  0
Injury, poisoning and procedural complications         
Transfusion-related acute lung injury  1  1/68 (1.47%)  1 0/45 (0.00%)  0 0/88 (0.00%)  0 0/55 (0.00%)  0
Investigations         
Cardiac murmur functional  1  0/68 (0.00%)  0 0/45 (0.00%)  0 1/88 (1.14%)  1 0/55 (0.00%)  0
Metabolism and nutrition disorders         
Dehydration  1  0/68 (0.00%)  0 0/45 (0.00%)  0 0/88 (0.00%)  0 1/55 (1.82%)  1
Hypoglycaemia neonatal  1  0/68 (0.00%)  0 0/45 (0.00%)  0 1/88 (1.14%)  1 0/55 (0.00%)  0
Hypokalaemia  1  0/68 (0.00%)  0 0/45 (0.00%)  0 1/88 (1.14%)  1 0/55 (0.00%)  0
Metabolic acidosis  1  0/68 (0.00%)  0 0/45 (0.00%)  0 1/88 (1.14%)  1 0/55 (0.00%)  0
Metabolic alkalosis  1  0/68 (0.00%)  0 0/45 (0.00%)  0 1/88 (1.14%)  1 0/55 (0.00%)  0
Neonatal hyponatraemia  1  0/68 (0.00%)  0 0/45 (0.00%)  0 1/88 (1.14%)  1 0/55 (0.00%)  0
Nervous system disorders         
Cerebral infarction foetal  1  0/68 (0.00%)  0 0/45 (0.00%)  0 1/88 (1.14%)  1 0/55 (0.00%)  0
Intraventricular haemorrhage neonatal  1  0/68 (0.00%)  0 0/45 (0.00%)  0 1/88 (1.14%)  1 0/55 (0.00%)  0
Pregnancy, puerperium and perinatal conditions         
Abortion missed  1  1/68 (1.47%)  1 0/45 (0.00%)  0 0/88 (0.00%)  0 0/55 (0.00%)  0
Abortion spontaneous  1  1/68 (1.47%)  1 0/45 (0.00%)  0 0/88 (0.00%)  0 0/55 (0.00%)  0
Antepartum haemorrhage  1  1/68 (1.47%)  1 1/45 (2.22%)  2 0/88 (0.00%)  0 0/55 (0.00%)  0
Arrested labour  1  0/68 (0.00%)  0 1/45 (2.22%)  1 0/88 (0.00%)  0 0/55 (0.00%)  0
Breech presentation  1  2/68 (2.94%)  2 2/45 (4.44%)  2 0/88 (0.00%)  0 0/55 (0.00%)  0
Cephalo-pelvic disproportion  1  2/68 (2.94%)  2 1/45 (2.22%)  1 0/88 (0.00%)  0 0/55 (0.00%)  0
Cervical incompetence  1  3/68 (4.41%)  3 0/45 (0.00%)  0 0/88 (0.00%)  0 0/55 (0.00%)  0
Cervix dystocia  1  1/68 (1.47%)  1 0/45 (0.00%)  0 0/88 (0.00%)  0 0/55 (0.00%)  0
Chorioamnionitis  1  1/68 (1.47%)  1 2/45 (4.44%)  2 0/88 (0.00%)  0 0/55 (0.00%)  0
Complication of delivery  1  0/68 (0.00%)  0 1/45 (2.22%)  1 0/88 (0.00%)  0 0/55 (0.00%)  0
Failed induction of labour  1  1/68 (1.47%)  1 0/45 (0.00%)  0 0/88 (0.00%)  0 0/55 (0.00%)  0
Foetal distress syndrome  1  2/68 (2.94%)  2 1/45 (2.22%)  1 0/88 (0.00%)  0 0/55 (0.00%)  0
Foetal hypokinesia  1  1/68 (1.47%)  1 0/45 (0.00%)  0 0/88 (0.00%)  0 0/55 (0.00%)  0
Foetal macrosomia  1  1/68 (1.47%)  1 0/45 (0.00%)  0 0/88 (0.00%)  0 0/55 (0.00%)  0
Foetal malposition  1  1/68 (1.47%)  1 0/45 (0.00%)  0 0/88 (0.00%)  0 0/55 (0.00%)  0
Foetal malpresentation  1  3/68 (4.41%)  3 0/45 (0.00%)  0 0/88 (0.00%)  0 0/55 (0.00%)  0
Intra-uterine death  1  1/68 (1.47%)  1 0/45 (0.00%)  0 0/88 (0.00%)  0 0/55 (0.00%)  0
Multiple pregnancy  1  1/68 (1.47%)  1 0/45 (0.00%)  0 0/88 (0.00%)  0 0/55 (0.00%)  0
Oligohydramnios  1  1/68 (1.47%)  1 0/45 (0.00%)  0 0/88 (0.00%)  0 0/55 (0.00%)  0
Placenta praevia  1  2/68 (2.94%)  2 6/45 (13.33%)  6 0/88 (0.00%)  0 0/55 (0.00%)  0
Pre-eclampsia  1  0/68 (0.00%)  0 1/45 (2.22%)  1 0/88 (0.00%)  0 0/55 (0.00%)  0
Pregnancy induced hypertension  1  0/68 (0.00%)  0 1/45 (2.22%)  1 0/88 (0.00%)  0 0/55 (0.00%)  0
Premature labour  1  14/68 (20.59%)  14 5/45 (11.11%)  5 0/88 (0.00%)  0 0/55 (0.00%)  0
Premature rupture of membranes  1  7/68 (10.29%)  7 4/45 (8.89%)  4 0/88 (0.00%)  0 0/55 (0.00%)  0
Premature separation of placenta  1  0/68 (0.00%)  0 1/45 (2.22%)  1 0/88 (0.00%)  0 0/55 (0.00%)  0
Prolonged labour  1  1/68 (1.47%)  1 0/45 (0.00%)  0 0/88 (0.00%)  0 0/55 (0.00%)  0
Stillbirth  1  3/68 (4.41%)  4 0/45 (0.00%)  0 0/88 (0.00%)  0 0/55 (0.00%)  0
Threatened labour  1  5/68 (7.35%)  5 1/45 (2.22%)  1 0/88 (0.00%)  0 0/55 (0.00%)  0
Twin pregnancy  1  9/68 (13.24%)  9 3/45 (6.67%)  3 0/88 (0.00%)  0 0/55 (0.00%)  0
Uterine contractions during pregnancy  1  1/68 (1.47%)  1 1/45 (2.22%)  2 0/88 (0.00%)  0 0/55 (0.00%)  0
Uterine hypotonus  1  1/68 (1.47%)  1 0/45 (0.00%)  0 0/88 (0.00%)  0 0/55 (0.00%)  0
Hypothermia neonatal  1  0/68 (0.00%)  0 0/45 (0.00%)  0 1/88 (1.14%)  1 0/55 (0.00%)  0
Jaundice neonatal  1  0/68 (0.00%)  0 0/45 (0.00%)  0 3/88 (3.41%)  3 5/55 (9.09%)  5
Premature baby  1  0/68 (0.00%)  0 0/45 (0.00%)  0 20/88 (22.73%)  20 9/55 (16.36%)  9
Small for dates baby  1  0/68 (0.00%)  0 0/45 (0.00%)  0 4/88 (4.55%)  4 2/55 (3.64%)  2
Hydrops foetalis  1  0/68 (0.00%)  0 0/45 (0.00%)  0 1/88 (1.14%)  1 0/55 (0.00%)  0
Renal and urinary disorders         
Nephrocalcinosis  1  0/68 (0.00%)  0 0/45 (0.00%)  0 1/88 (1.14%)  1 0/55 (0.00%)  0
Pyelocaliectasis  1  0/68 (0.00%)  0 0/45 (0.00%)  0 0/88 (0.00%)  0 1/55 (1.82%)  1
Reproductive system and breast disorders         
Ovarian cyst  1  0/68 (0.00%)  0 0/45 (0.00%)  0 0/88 (0.00%)  0 1/55 (1.82%)  1
Respiratory, thoracic and mediastinal disorders         
Acute respiratory distress syndrome  1  1/68 (1.47%)  1 0/45 (0.00%)  0 0/88 (0.00%)  0 0/55 (0.00%)  0
Bronchopulmonary dysplasia  1  0/68 (0.00%)  0 0/45 (0.00%)  0 1/88 (1.14%)  1 0/55 (0.00%)  0
Hypoventilation neonatal  1  0/68 (0.00%)  0 0/45 (0.00%)  0 2/88 (2.27%)  2 0/55 (0.00%)  0
Infantile apnoeic attack  1  0/68 (0.00%)  0 0/45 (0.00%)  0 0/88 (0.00%)  0 2/55 (3.64%)  2
Neonatal respiratory distress syndrome  1  0/68 (0.00%)  0 0/45 (0.00%)  0 4/88 (4.55%)  4 3/55 (5.45%)  3
Pneumothorax  1  0/68 (0.00%)  0 0/45 (0.00%)  0 2/88 (2.27%)  2 0/55 (0.00%)  0
Pulmonary hypertensive crisis  1  0/68 (0.00%)  0 0/45 (0.00%)  0 1/88 (1.14%)  1 0/55 (0.00%)  0
Respiratory disorder neonatal  1  0/68 (0.00%)  0 0/45 (0.00%)  0 0/88 (0.00%)  0 1/55 (1.82%)  1
Transient tachypnoea of the newborn  1  0/68 (0.00%)  0 0/45 (0.00%)  0 5/88 (5.68%)  5 3/55 (5.45%)  3
Wheezing  1  0/68 (0.00%)  0 0/45 (0.00%)  0 1/88 (1.14%)  1 0/55 (0.00%)  0
Surgical and medical procedures         
Cervix cerclage procedure  1  1/68 (1.47%)  1 0/45 (0.00%)  0 0/88 (0.00%)  0 0/55 (0.00%)  0
Vascular disorders         
Neonatal hypotension  1  0/68 (0.00%)  0 0/45 (0.00%)  0 1/88 (1.14%)  1 0/55 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Corifollitropin Alfa 100 μg Expectant Mothers recFSH 150 IU Expectant Mothers Corifollitropin Alfa 100 μg Fetuses at 10 Weeks After ET recFSH 150 IU Fetuses at 10 Weeks After ET
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   13/68 (19.12%)      17/45 (37.78%)      9/88 (10.23%)      5/55 (9.09%)    
Blood and lymphatic system disorders         
Anaemia  1  5/68 (7.35%)  5 6/45 (13.33%)  6 0/88 (0.00%)  0 0/55 (0.00%)  0
General disorders         
Pyrexia  1  4/68 (5.88%)  4 0/45 (0.00%)  0 0/88 (0.00%)  0 2/55 (3.64%)  2
Hepatobiliary disorders         
Hyperbilirubinaemia neonatal  1  0/68 (0.00%)  0 0/45 (0.00%)  0 5/88 (5.68%)  5 0/55 (0.00%)  0
Pregnancy, puerperium and perinatal conditions         
Abnormal labour  1  0/68 (0.00%)  0 3/45 (6.67%)  3 0/88 (0.00%)  0 0/55 (0.00%)  0
Antepartum haemorrhage  1  3/68 (4.41%)  3 4/45 (8.89%)  4 0/88 (0.00%)  0 0/55 (0.00%)  0
Placenta praevia  1  0/68 (0.00%)  0 3/45 (6.67%)  3 0/88 (0.00%)  0 0/55 (0.00%)  0
Threatened labour  1  1/68 (1.47%)  1 4/45 (8.89%)  4 0/88 (0.00%)  0 0/55 (0.00%)  0
Jaundice neonatal  1  0/68 (0.00%)  0 0/45 (0.00%)  0 4/88 (4.55%)  6 3/55 (5.45%)  3
Respiratory, thoracic and mediastinal disorders         
Cough  1  5/68 (7.35%)  5 0/45 (0.00%)  0 0/88 (0.00%)  0 2/55 (3.64%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.0
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.
The Sponsor recognizes the right of the investigator(s) to publish, but all publications must be based on data validated and released by the Sponsor. Any such scientific paper, presentation, or other communication concerning the clinical trial described in this protocol will first be submitted to Sponsor, at least six weeks ahead of estimated publication or presentation, for written consent, which shall not be withheld unreasonably.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
EMail: ClinicalTrialsDisclosure@merck.com
Layout table for additonal information
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00702624     History of Changes
Other Study ID Numbers: P05710
2006-003812-23 ( EudraCT Number )
107014 ( Other Identifier: Organon )
MK-8962-003 ( Other Identifier: Merck )
First Submitted: June 18, 2008
First Posted: June 20, 2008
Results First Submitted: April 13, 2015
Results First Posted: April 30, 2015
Last Update Posted: March 21, 2017