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Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established in Clinical Trial P05714 (Care Program)(P05715) (Care)

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ClinicalTrials.gov Identifier: NCT00702234
Recruitment Status : Completed
First Posted : June 20, 2008
Results First Posted : April 27, 2015
Last Update Posted : April 18, 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 Biological: Corifollitropin alfa
Biological: GnRH antagonist
Biological: (rec)hCG
Biological: FSH
Drug: Progesterone
Enrollment 268
Recruitment Details Of 272 participants with ongoing pregnancy at 10 weeks after fresh embryo transfer (ET) in base study P05714 (NCT00696878), 268 enrolled in this follow-up study P05715. A participant could enter follow-up study without meeting formal definition for "Completion" of base study.
Pre-assignment Details To complete base study P05714 (NCT00696878), a participant must have embryo transfer in the 3rd Controlled Ovarian Stimulation (COS) cycle (Treatment Cycle 3). For this follow-up trial P05715, study completion for participant (expectant mother) or live born infant was defined as completion of infant follow-up visit at 4-12 weeks after delivery.
Arm/Group Title Women/Expectant Mothers - Corifollitropin Alfa 150 µg Fetuses Present at 10 Weeks After Fresh ET in Base Study
Hide Arm/Group Description In base study P05714 (NCT00696878), up to 3 COS cycles were performed, each including the following treatments: 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 cycles (up to 3 after each COS cycle) could occur. Participants with confirmed pregnancy at least 10 weeks after fresh ET in the base study were eligible for this follow-up study. In this follow-up study P05715, no study drugs were administered. This group includes fetuses associated with expectant mothers who were administered corifollitropin alfa in base study P05714 (NCT00696878) who were enrolled in this follow-up study P05715. The fetuses were present at 10 weeks after fresh ET in base study P05714 and/or at enrollment of the expectant mother in this follow-up study P05715.
Period Title: Base Study (NCT00696878)
Started 682 0
Completed 178 0
Not Completed 504 0
Period Title: Follow-up Study: Expectant Mothers
Started 268 [1] 0
Completed 246 0
Not Completed 22 0
[1]
A participant could enter follow-up study without meeting definition for "Completion" of base study
Period Title: Follow-up Study: Fetuses/Infants
Started 0 315 [1]
Live Born Infants 0 304 [2]
Completed 0 288 [3]
Not Completed 0 27
[1]
Fetuses present 10 weeks after fresh ET and/or at enrollment of expectant mother in follow-up study
[2]
Of the 11 that were not live born infants, outcome is known for 8 (fetus was lost) and unknown for 3
[3]
All 288 who completed were live born infants
Arm/Group Title Expectant Mothers - Corifollitropin Alfa 150 µg
Hide Arm/Group Description In base study P05714 (NCT00696878), up to 3 COS cycles were performed, each including the following treatments: 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, Frozen-Thawed Embryo Transfer cycles (up to 3 after each COS cycle) could occur. Participants with confirmed pregnancy at least 10 weeks after fresh ET in the base study were eligible for this follow-up study. In this follow-up study P05715, no study drugs were administered.
Overall Number of Baseline Participants 268
Hide Baseline Analysis Population Description
Individuals who participated in base study P05714 (NCT00696878) and received at least one dose of corifollitropin alfa, who had an ongoing pregnancy confirmed by ultrasound at least 10 weeks after fresh ET in base study P05714 and were able and willing to give written informed consent to be enrolled in the follow-up study.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 268 participants
32.8  (3.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 268 participants
Female
268
 100.0%
Male
0
   0.0%
1.Primary Outcome
Title Percentage of Women With Ongoing Pregnancy After a Corifollitropin Alfa COS Cycle in Base Study and ≥1 Live Born Infant During Follow-up (Live Birth Rate)
Hide Description The live birth rate was defined as the number of participants who had an ongoing pregnancy after a corifollitropin alfa COS cycle in base study P05714 (NCT00696878) and who had at least one live born infant during follow-up, divided by the number of participants treated in the base study. For this analysis, it was assumed that any participants with ongoing pregnancy after a COS cycle in base study who did not enroll in follow-up study P05715 had no live born infants.
Time Frame Up to approximately 32 months after first dose of corifollitropin alfa in base study P05714 (NCT00696878)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants administered corifollitropin alfa in base study P05714 (NCT00696878)
Arm/Group Title Women - Corifollitropin Alfa 150 µg
Hide Arm/Group Description:
In base study P05714 (NCT00696878), up to 3 COS cycles were performed, each including the following treatments: 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, Frozen-Thawed Embryo Transfer cycles (up to 3 after each COS cycle) could occur. Participants with confirmed pregnancy at least 10 weeks after fresh ET in the base study were eligible for this follow-up study. In this follow-up study P05715, no study drugs were administered.
Overall Number of Participants Analyzed 682
Measure Type: Number
Unit of Measure: percentage of participants
37.8
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 fresh ET in base study P05714 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 in base study P05714 (NCT00696878) and who enrolled in the follow-up study.
Arm/Group Title Expectant Mothers - Corifollitropin Alfa 150 µg
Hide Arm/Group Description:
In base study P05714 (NCT00696878), up to 3 COS cycles were performed, each including the following treatments: 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, Frozen-Thawed Embryo Transfer cycles (up to 3 after each COS cycle) could occur. Participants with confirmed pregnancy at least 10 weeks after fresh ET in the base study were eligible for this follow-up study. In this follow-up study P05715, no study drugs were administered.
Overall Number of Participants Analyzed 268
Measure Type: Number
Unit of Measure: participants
203
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 fresh ET in base study P05714 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 in base study P05714 (NCT00696878) and who enrolled in the follow-up study.
Arm/Group Title Expectant Mothers - Corifollitropin Alfa 150 µg
Hide Arm/Group Description:
In base study P05714 (NCT00696878), up to 3 COS cycles were performed, each including the following treatments: 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, Frozen-Thawed Embryo Transfer cycles (up to 3 after each COS cycle) could occur. Participants with confirmed pregnancy at least 10 weeks after fresh ET in the base study were eligible for this follow-up study. In this follow-up study P05715, no study drugs were administered.
Overall Number of Participants Analyzed 268
Measure Type: Number
Unit of Measure: participants
145
4.Primary Outcome
Title Number of Live Born 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 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 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 in base study P05714 (NCT00696878) and who enrolled in the follow-up study.
Arm/Group Title Live Born Infants
Hide Arm/Group Description:
This group includes infants born to mothers who were administered corifollitropin alfa in base study P05714 (NCT00696878) and who were enrolled in this follow-up study P05715. These infants, whose gestation outcome was live birth, are a subgroup of the total number of fetuses that were present at 10 weeks after fresh ET in base study P05714 and/or at enrollment of the expectant mother in this follow-up study P05715. Fetuses not born alive or with unknown outcome are not included in this reporting group.
Overall Number of Participants Analyzed 304
Measure Type: Number
Unit of Measure: participants
99
5.Primary Outcome
Title Number of Live Born 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 in base study P05714 (NCT00696878) and who enrolled in the follow-up study.
Arm/Group Title Live Born Infants
Hide Arm/Group Description:
This group includes infants born to mothers who were administered corifollitropin alfa in base study P05714 (NCT00696878) and who were enrolled in this follow-up study P05715. These infants, whose gestation outcome was live birth, are a subgroup of the total number of fetuses that were present at 10 weeks after fresh ET in base study P05714 and/or at enrollment of the expectant mother in this follow-up study P05715. Fetuses not born alive or with unknown outcome are not included in this reporting group.
Overall Number of Participants Analyzed 304
Measure Type: Number
Unit of Measure: participants
79
Time Frame From approximately 10 weeks after fresh ET in base study P05714 (NCT00696878) 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 Expectant Mothers - Corifollitropin Alfa 150 µg Fetuses Present at 10 Weeks After Fresh ET in Base Study
Hide Arm/Group Description In base study P05714 (NCT00696878), up to 3 COS cycles were performed, each including the following treatments: 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, Frozen-Thawed Embryo Transfer cycles (up to 3 after each COS cycle) could occur. Participants with confirmed pregnancy at least 10 weeks after fresh ET in the base study were eligible for this follow-up study. In this follow-up study P05715, no study drugs were administered. This group includes fetuses associated with expectant mothers who were administered corifollitropin alfa in base study P05714 (NCT00696878) who were enrolled in this follow-up study P05715. The fetuses were present at 10 weeks after fresh ET in base study P05714 and/or at enrollment of the expectant mother in this follow-up study P05715.
All-Cause Mortality
Expectant Mothers - Corifollitropin Alfa 150 µg Fetuses Present at 10 Weeks After Fresh ET in Base Study
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Expectant Mothers - Corifollitropin Alfa 150 µg Fetuses Present at 10 Weeks After Fresh ET in Base Study
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   145/268 (54.10%)      84/315 (26.67%)    
Blood and lymphatic system disorders     
Anaemia  1  1/268 (0.37%)  1 0/315 (0.00%)  0
Anaemia neonatal  1  0/268 (0.00%)  0 3/315 (0.95%)  3
Disseminated intravascular coagulation in newborn  1  0/268 (0.00%)  0 1/315 (0.32%)  1
Cardiac disorders     
Bradycardia foetal  1  1/268 (0.37%)  1 1/315 (0.32%)  1
Bradycardia neonatal  1  0/268 (0.00%)  0 1/315 (0.32%)  1
Cardio-respiratory arrest neonatal  1  0/268 (0.00%)  0 1/315 (0.32%)  1
Foetal heart rate disorder  1  1/268 (0.37%)  1 0/315 (0.00%)  0
Ventricular hypokinesia  1  0/268 (0.00%)  0 1/315 (0.32%)  1
Congenital, familial and genetic disorders     
Anal atresia  1  0/268 (0.00%)  0 2/315 (0.63%)  2
Ankyloglossia congenital  1  0/268 (0.00%)  0 1/315 (0.32%)  1
Anomaly of external ear congenital  1  0/268 (0.00%)  0 1/315 (0.32%)  1
Atrial septal defect  1  0/268 (0.00%)  0 4/315 (1.27%)  5
Cleft palate  1  0/268 (0.00%)  0 1/315 (0.32%)  1
Congenital cytomegalovirus infection  1  0/268 (0.00%)  0 1/315 (0.32%)  1
Congenital diaphragmatic hernia  1  0/268 (0.00%)  0 1/315 (0.32%)  1
Congenital hand malformation  1  0/268 (0.00%)  0 1/315 (0.32%)  1
Congenital hydrocephalus  1  0/268 (0.00%)  0 1/315 (0.32%)  1
Congenital infection  1  0/268 (0.00%)  0 1/315 (0.32%)  1
Congenital naevus  1  0/268 (0.00%)  0 1/315 (0.32%)  1
Congenital nose malformation  1  0/268 (0.00%)  0 1/315 (0.32%)  1
Congenital pulmonary artery anomaly  1  0/268 (0.00%)  0 1/315 (0.32%)  1
Congenital pulmonary hypertension  1  0/268 (0.00%)  0 1/315 (0.32%)  1
Congenital tongue anomaly  1  0/268 (0.00%)  0 1/315 (0.32%)  1
Congenital torticollis  1  0/268 (0.00%)  0 1/315 (0.32%)  1
Cryptorchism  1  0/268 (0.00%)  0 1/315 (0.32%)  1
Cystic lymphangioma  1  0/268 (0.00%)  0 1/315 (0.32%)  1
Duodenal atresia  1  0/268 (0.00%)  0 1/315 (0.32%)  1
Dysmorphism  1  0/268 (0.00%)  0 1/315 (0.32%)  1
Factor IX deficiency  1  0/268 (0.00%)  0 1/315 (0.32%)  1
Factor VIII deficiency  1  0/268 (0.00%)  0 2/315 (0.63%)  2
Fallot's tetralogy  1  0/268 (0.00%)  0 1/315 (0.32%)  1
Haemangioma congenital  1  0/268 (0.00%)  0 1/315 (0.32%)  1
Laryngomalacia  1  0/268 (0.00%)  0 1/315 (0.32%)  1
Oculoauriculovertebral dysplasia  1  0/268 (0.00%)  0 1/315 (0.32%)  1
Patent ductus arteriosus  1  0/268 (0.00%)  0 5/315 (1.59%)  5
Pulmonary artery stenosis congenital  1  0/268 (0.00%)  0 1/315 (0.32%)  1
Pulmonary malformation  1  0/268 (0.00%)  0 1/315 (0.32%)  1
Pulmonary sequestration  1  0/268 (0.00%)  0 1/315 (0.32%)  1
Pyloric stenosis  1  0/268 (0.00%)  0 1/315 (0.32%)  1
Renal dysplasia  1  0/268 (0.00%)  0 1/315 (0.32%)  1
Skull malformation  1  0/268 (0.00%)  0 1/315 (0.32%)  1
Solitary kidney  1  0/268 (0.00%)  0 1/315 (0.32%)  1
Strabismus congenital  1  0/268 (0.00%)  0 1/315 (0.32%)  1
Syndactyly  1  0/268 (0.00%)  0 1/315 (0.32%)  1
Talipes  1  0/268 (0.00%)  0 1/315 (0.32%)  1
Trisomy 18  1  0/268 (0.00%)  0 1/315 (0.32%)  1
Trisomy 21  1  0/268 (0.00%)  0 3/315 (0.95%)  3
VACTERL syndrome  1  0/268 (0.00%)  0 1/315 (0.32%)  1
Ventricular septal defect  1  0/268 (0.00%)  0 1/315 (0.32%)  1
Ear and labyrinth disorders     
Hypoacusis  1  0/268 (0.00%)  0 1/315 (0.32%)  1
Eye disorders     
Dacryostenosis acquired  1  0/268 (0.00%)  0 2/315 (0.63%)  2
Retinopathy of prematurity  1  0/268 (0.00%)  0 1/315 (0.32%)  1
Gastrointestinal disorders     
Abdominal pain  1  1/268 (0.37%)  1 0/315 (0.00%)  0
Dysphagia  1  0/268 (0.00%)  0 1/315 (0.32%)  1
Gastrooesophageal reflux disease  1  0/268 (0.00%)  0 2/315 (0.63%)  2
Haematemesis  1  0/268 (0.00%)  0 1/315 (0.32%)  1
Inguinal hernia  1  0/268 (0.00%)  0 1/315 (0.32%)  1
Rectal haemorrhage  1  0/268 (0.00%)  0 1/315 (0.32%)  1
General disorders     
Multi-organ failure  1  0/268 (0.00%)  0 1/315 (0.32%)  1
Hepatobiliary disorders     
Acute hepatic failure  1  0/268 (0.00%)  0 1/315 (0.32%)  1
Cholecystitis  1  1/268 (0.37%)  1 0/315 (0.00%)  0
Cholelithiasis  1  1/268 (0.37%)  1 0/315 (0.00%)  0
Cholestasis of pregnancy  1  3/268 (1.12%)  3 0/315 (0.00%)  0
Hyperbilirubinaemia neonatal  1  0/268 (0.00%)  0 10/315 (3.17%)  10
Immune system disorders     
Milk allergy  1  0/268 (0.00%)  0 1/315 (0.32%)  1
Infections and infestations     
Bronchiolitis  1  0/268 (0.00%)  0 1/315 (0.32%)  1
Bronchopneumonia  1  0/268 (0.00%)  0 1/315 (0.32%)  1
Endometritis  1  1/268 (0.37%)  1 0/315 (0.00%)  0
Neonatal infection  1  0/268 (0.00%)  0 2/315 (0.63%)  2
Rotavirus infection  1  0/268 (0.00%)  0 1/315 (0.32%)  1
Sepsis neonatal  1  0/268 (0.00%)  0 1/315 (0.32%)  1
Uterine infection  1  1/268 (0.37%)  1 0/315 (0.00%)  0
Injury, poisoning and procedural complications     
Concussion  1  0/268 (0.00%)  0 1/315 (0.32%)  1
Perineal laceration  1  1/268 (0.37%)  1 0/315 (0.00%)  0
Skull fracture  1  0/268 (0.00%)  0 1/315 (0.32%)  1
Traumatic haematoma  1  0/268 (0.00%)  0 1/315 (0.32%)  1
Investigations     
Amniotic fluid volume decreased  1  1/268 (0.37%)  1 0/315 (0.00%)  0
Blood bilirubin increased  1  0/268 (0.00%)  0 1/315 (0.32%)  1
Foetal heart rate abnormal  1  1/268 (0.37%)  1 0/315 (0.00%)  0
Foetal heart rate increased  1  1/268 (0.37%)  1 0/315 (0.00%)  0
Metabolism and nutrition disorders     
Gestational diabetes  1  1/268 (0.37%)  1 0/315 (0.00%)  0
Hypoglycaemia neonatal  1  0/268 (0.00%)  0 3/315 (0.95%)  3
Malnutrition  1  0/268 (0.00%)  0 1/315 (0.32%)  1
Metabolic acidosis  1  0/268 (0.00%)  0 1/315 (0.32%)  1
Musculoskeletal and connective tissue disorders     
Delayed fontanelle closure  1  0/268 (0.00%)  0 1/315 (0.32%)  1
Torticollis  1  0/268 (0.00%)  0 1/315 (0.32%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Haemangioma  1  0/268 (0.00%)  0 1/315 (0.32%)  1
Malignant melanoma  1  1/268 (0.37%)  1 0/315 (0.00%)  0
Nervous system disorders     
Cerebral haemorrhage  1  0/268 (0.00%)  0 1/315 (0.32%)  1
Cerebral haemorrhage neonatal  1  0/268 (0.00%)  0 1/315 (0.32%)  1
Pregnancy, puerperium and perinatal conditions     
Abortion spontaneous  1  3/268 (1.12%)  3 0/315 (0.00%)  0
Abortion threatened  1  1/268 (0.37%)  1 0/315 (0.00%)  0
Antepartum haemorrhage  1  4/268 (1.49%)  5 0/315 (0.00%)  0
Arrested labour  1  18/268 (6.72%)  18 0/315 (0.00%)  0
Breech presentation  1  17/268 (6.34%)  17 0/315 (0.00%)  0
Cephalo-pelvic disproportion  1  5/268 (1.87%)  5 0/315 (0.00%)  0
Cervical incompetence  1  2/268 (0.75%)  2 0/315 (0.00%)  0
Delayed delivery  1  1/268 (0.37%)  1 0/315 (0.00%)  0
Failed induction of labour  1  2/268 (0.75%)  2 0/315 (0.00%)  0
Foetal acidosis  1  0/268 (0.00%)  0 2/315 (0.63%)  2
Foetal distress syndrome  1  10/268 (3.73%)  10 0/315 (0.00%)  0
Foetal growth retardation  1  3/268 (1.12%)  3 1/315 (0.32%)  1
Foetal macrosomia  1  2/268 (0.75%)  2 0/315 (0.00%)  0
Foetal malposition  1  1/268 (0.37%)  1 0/315 (0.00%)  0
Foetal malpresentation  1  2/268 (0.75%)  2 0/315 (0.00%)  0
HELLP syndrome  1  2/268 (0.75%)  2 0/315 (0.00%)  0
High risk pregnancy  1  1/268 (0.37%)  1 0/315 (0.00%)  0
Intra-uterine death  1  3/268 (1.12%)  3 0/315 (0.00%)  0
Jaundice neonatal  1  0/268 (0.00%)  0 11/315 (3.49%)  11
Meconium in amniotic fluid  1  1/268 (0.37%)  1 0/315 (0.00%)  0
Multiple pregnancy  1  2/268 (0.75%)  2 0/315 (0.00%)  0
Oligohydramnios  1  3/268 (1.12%)  3 0/315 (0.00%)  0
Placenta praevia  1  4/268 (1.49%)  4 0/315 (0.00%)  0
Postpartum haemorrhage  1  5/268 (1.87%)  5 0/315 (0.00%)  0
Pre-eclampsia  1  10/268 (3.73%)  10 0/315 (0.00%)  0
Pregnancy induced hypertension  1  7/268 (2.61%)  7 0/315 (0.00%)  0
Premature baby  1  0/268 (0.00%)  0 50/315 (15.87%)  50
Premature labour  1  22/268 (8.21%)  22 0/315 (0.00%)  0
Premature rupture of membranes  1  17/268 (6.34%)  17 0/315 (0.00%)  0
Premature separation of placenta  1  5/268 (1.87%)  5 0/315 (0.00%)  0
Previous caesarean section  1  1/268 (0.37%)  1 0/315 (0.00%)  0
Prolonged labour  1  5/268 (1.87%)  5 0/315 (0.00%)  0
Retained placenta or membranes  1  1/268 (0.37%)  1 0/315 (0.00%)  0
Small for dates baby  1  0/268 (0.00%)  0 7/315 (2.22%)  7
Threatened labour  1  3/268 (1.12%)  3 0/315 (0.00%)  0
Transverse presentation  1  3/268 (1.12%)  3 0/315 (0.00%)  0
Twin pregnancy  1  15/268 (5.60%)  15 0/315 (0.00%)  0
Umbilical cord abnormality  1  1/268 (0.37%)  1 0/315 (0.00%)  0
Umbilical cord prolapse  1  1/268 (0.37%)  1 0/315 (0.00%)  0
Uterine contractions abnormal  1  1/268 (0.37%)  1 0/315 (0.00%)  0
Psychiatric disorders     
Mental disorder  1  1/268 (0.37%)  1 0/315 (0.00%)  0
Renal and urinary disorders     
Proteinuria  1  1/268 (0.37%)  1 0/315 (0.00%)  0
Reproductive system and breast disorders     
Perineal fistula  1  0/268 (0.00%)  0 1/315 (0.32%)  1
Vaginal laceration  1  1/268 (0.37%)  1 0/315 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Asthmatic crisis  1  1/268 (0.37%)  1 0/315 (0.00%)  0
Bronchial obstruction  1  1/268 (0.37%)  1 0/315 (0.00%)  0
Immature respiratory system  1  0/268 (0.00%)  0 1/315 (0.32%)  1
Infantile apnoeic attack  1  0/268 (0.00%)  0 4/315 (1.27%)  4
Neonatal asphyxia  1  1/268 (0.37%)  1 0/315 (0.00%)  0
Neonatal aspiration  1  0/268 (0.00%)  0 1/315 (0.32%)  1
Neonatal respiratory distress syndrome  1  0/268 (0.00%)  0 12/315 (3.81%)  12
Pneumothorax  1  0/268 (0.00%)  0 2/315 (0.63%)  2
Respiratory failure  1  0/268 (0.00%)  0 1/315 (0.32%)  1
Skin and subcutaneous tissue disorders     
Cafe au lait spots  1  0/268 (0.00%)  0 1/315 (0.32%)  1
Seborrhoeic dermatitis  1  0/268 (0.00%)  0 1/315 (0.32%)  1
Surgical and medical procedures     
Abortion induced  1  2/268 (0.75%)  2 0/315 (0.00%)  0
Caesarean section  1  3/268 (1.12%)  3 0/315 (0.00%)  0
Selective abortion  1  1/268 (0.37%)  1 0/315 (0.00%)  0
Vascular disorders     
Hypotension  1  0/268 (0.00%)  0 1/315 (0.32%)  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%
Expectant Mothers - Corifollitropin Alfa 150 µg Fetuses Present at 10 Weeks After Fresh ET in Base Study
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/268 (0.00%)      0/315 (0.00%)    
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
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: NCT00702234     History of Changes
Other Study ID Numbers: P05715
2004-004967-30 ( EudraCT Number )
38829 ( Other Identifier: Organon )
MK-8962-008 ( Other Identifier: Merck )
First Submitted: June 18, 2008
First Posted: June 20, 2008
Results First Submitted: April 9, 2015
Results First Posted: April 27, 2015
Last Update Posted: April 18, 2017