Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established in Clinical Trial P05787 (P05712)

• Sponsor: Organon and Co (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00703014
• Collaborator: (none)
• Enrollment: 541
• Actual Duration (Months): 32.1

Study Details

Study Description

Brief Summary

The objective of this trial was to evaluate whether Corifollitropin Alfa treatment for the induction of multifollicular growth in women undergoing controlled ovarian stimulation (COS) prior to in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) was safe for pregnant participants and their offspring. The primary endpoint was the take-home baby rate calculated as the number of participants with an ongoing pregnancy in Base Trial P05787 (NCT00696800) with at least one live born infant relative to the number of participants in the Base Trial, and to the number of participants in the Base Trial with Embryo Transfer (ET).

Condition or Disease	Intervention/Treatment	Phase
Pregnancy; Neonates	Drug: Corifollitropin Alfa 150 μg; Biological: 200 IU RecFSH/Follitropin beta (Days 1 to 7); Drug: Placebo for Corifollitropin Alfa; Drug: Placebo for RecFSH/Follitropin beta; Biological: 200 IU RecFSH/Follitropin beta (Days 8 to hCG); Drug: Ganirelix; Biological: hCG; Biological: Progesterone

Detailed Description

This is a follow-up protocol to prospectively monitor pregnancy, delivery, and neonatal outcome of all women who were treated with Corifollitropin Alfa or recFSH and became pregnant during Base Trial P05787 (NCT00696800). For this trial, no study specific assessments are required, but information as obtained in standard practice will be used.

Study Design

• Study Type: Observational
• Actual Enrollment: 541 participants
• Observational Model: Other
• Time Perspective: Prospective
• Official Title: Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established After Controlled Ovarian Stimulation in Clinical Trial 38819 for Org 36286 (Corifollitropin Alfa)
• Actual Study Start Date: Jul 13, 2006
• Actual Primary Completion Date: Apr 18, 2008
• Actual Study Completion Date: Mar 15, 2009

Arms and Interventions

Arm	Intervention/Treatment
Mothers Corifollitropin Alfa 150 µg Participants from the Base Trial P05787 who received a single subcutaneous (SC) injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recombinant Follicle Stimulating Hormone (recFSH); followed by daily SC injections with 200 IU recFSH up to the day of human chorionogonadotropin (hCG); multiple daily SC injections of Ganirelix from Stimulation Day 5 to the day of hCG; a single dose of hCG (5000 or 10,000 IU/USP) was administered when 3 follicles >= 17 mm were observed; and on the day of oocyte pick up (OPU) daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the Base Trial were enrolled in Follow Up Trial P05712, where no study treatments were given, and pregnancy, delivery and neonatal outcome were monitored.	Drug: Corifollitropin Alfa 150 μg; In the Base Trial P05787, on the morning of day 2 or 3 of the menstrual cycle (Stimulation Day 1), a single SC injection of 150 μg (0.5 mL) Corifollitropin Alfa was administered in the abdominal wall.; Drug: Placebo for RecFSH/Follitropin beta; In the Base Trial P05787, daily SC injections of an identical ready-for-use solution, but without the active ingredient, supplied in cartridges for SC injection with the Follistim Pen, were started on Stimulation Day 1 and continued up to and including Stimulation Day 7.; Biological: 200 IU RecFSH/Follitropin beta (Days 8 to hCG); In the Base Trial P05787, from Stimulation Day 8 onwards a daily SC dose of 200 IU recFSH was administered up to and including the Day of hCG.; Drug: Ganirelix; In the Base Trial P05787, on Stimulation Day 5 a daily SC injection of 0.25 mg was started, which continued up to and including the day of hCG.; Biological: hCG; In the Base Trial P05787, when 3 follicles >= 17 mm were observed by USS, a single dose of 10,000 IU/USP hCG was administered; or, for those at risk for Ovarian Hyperstimulation Syndrome (OHSS), a lower dose of 5,000 IU/USP; Biological: Progesterone; In the Base Trial P05787, on the day of OPU, luteal phase support was started by administering micronized progesterone of at least 600 mg/day vaginally, or at least 50 mg/day intramuscular (IM), which continued for at least 6 weeks, or up to menses.
Mothers recFSH 200 IU Participants from the Base Trial P05787 who received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix from Stimulation Day 5 to the day of hCG; a single dose of hCG (5000 or 10,000 IU/USP) was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the Base Trial were enrolled in Follow Up Trial P05712, where no study treatments were given, and pregnancy, delivery and neonatal outcome were monitored.	Biological: 200 IU RecFSH/Follitropin beta (Days 1 to 7); In the Base Trial P05787, daily SC injections with 200 IU fixed dose recFSH were started on Stimulation Day 1 and continued up to and including Stimulation Day 7.; Other Names: follitropin beta Puregon® Follistim® ; Drug: Placebo for Corifollitropin Alfa; In the Base Trial P05787, on the morning of day 2 or 3 of the menstrual cycle (Stimulation Day 1), a single SC injection from a pre-filled syringe containing an identical solution when compared to Corifollitropin Alfa was administered in the abdominal wall.; Biological: 200 IU RecFSH/Follitropin beta (Days 8 to hCG); In the Base Trial P05787, from Stimulation Day 8 onwards a daily SC dose of 200 IU recFSH was administered up to and including the Day of hCG.; Drug: Ganirelix; In the Base Trial P05787, on Stimulation Day 5 a daily SC injection of 0.25 mg was started, which continued up to and including the day of hCG.; Biological: hCG; In the Base Trial P05787, when 3 follicles >= 17 mm were observed by USS, a single dose of 10,000 IU/USP hCG was administered; or, for those at risk for Ovarian Hyperstimulation Syndrome (OHSS), a lower dose of 5,000 IU/USP; Biological: Progesterone; In the Base Trial P05787, on the day of OPU, luteal phase support was started by administering micronized progesterone of at least 600 mg/day vaginally, or at least 50 mg/day intramuscular (IM), which continued for at least 6 weeks, or up to menses.

Outcome Measures

Primary Outcome Measures

1. Number of Mothers in Current Follow Up Trial Experiencing Adverse Events (AEs) [Up to one day following delivery (up to 1 year)]

   An AE is any untoward medical occurrence in a trial participant administered a pharmaceutical product, and which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including laboratory finding), symptom, or disease temporally associated with the use of investigational medicinal product.

2. Number of Mothers in Current Follow Up Trial Experiencing Serious AEs (SAEs) [Up to one day following delivery (up to 1 year)]

   A SAE is any untoward medical occurrence that at any dose resulted in the following: death, was life threatening, required in-patient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, or was a congenital anomaly/birth defect.

3. Number of Infants Born in Current Follow Up Trial Experiencing AEs [Up to 12 weeks following delivery (up to 1 year)]

   An AE is any untoward medical occurrence in a trial participant administered a pharmaceutical product, and which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including laboratory finding), symptom, or disease temporally associated with the use of investigational medicinal product.

4. Number of Infants in Current Follow Up Trial Experiencing SAEs [Up to 12 weeks following delivery (up to 1 year)]

   A SAE is any untoward medical occurrence that at any dose resulted in the following: death, was life threatening, required in-patient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, or was a congenital anomaly/birth defect.

5. Percentage of Mothers From the Base Trial P05787 With at Least One Live Born Infant (Take-home Baby Rate) Relative to the Number of Participants in the Base Trial. [At least 10 weeks after embryo transfer in Base Trial P05787 up to birth in current follow up Trial (up to 1 year)]

   The take-home baby rate is 100 X the number of participants with an ongoing pregnancy in Base Trial P05787 (NCT00696800), from the Intent-to-Treat (ITT) group, with at least one live born infant relative to the number of participants in the Base Trial.

6. Percentage of Mothers From the Base Trial P05787 With at Least One Live Born Infant (Take-home Baby Rate) Relative to the Number of Participants From the Base Trial With Embryo Transfer. [At least 10 weeks after embryo transfer in Base Trial P05787 up to birth in current Follow Up Trial (up to 1 year)]

   The take-home baby rate is 100 X the number of participants with an ongoing pregnancy in Base Trial P05787 (NCT00696800), from the ITT group, with at least one live born infant relative to the number of participants from the Base Trial with embryo transfer.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 36 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Participants who received at least one dose of either Corifollitropin Alfa or

Puregon®/Follistim® AQ Cartridge in Base Trial P05787 (NCT00696800);

• Ongoing pregnancy confirmed by ultrasound at least 10 weeks after embryo transfer in Base Trial P05787 (NCT00696800);

• Able and willing to give written informed consent.

Exclusion Criteria:

• None

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Organon and Co

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Organon and Co
• ClinicalTrials.gov Identifier: NCT00703014
• Other Study ID Numbers: P05712; 2004-004772-36; 38821; MK-8962-005
• First Posted: Jun 20, 2008
• Last Update Posted: Feb 3, 2022
• Last Verified: Feb 1, 2022

• Keywords provided by Organon and Co: Neonatal outcome; Congenital malformations; In-Vitro fertilization; Controlled ovarian stimulation; Follow-up
• Additional relevant MeSH terms: Progesterone; Follicle Stimulating Hormone; Ganirelix

Study Results

Participant Flow

Pre-assignment Detail	Period one consists of mothers from the Base Trial P05787 (NCT00696800), randomized to treatment groups Corifollitropin Alfa (Org 36286) or recombinant Follicle Stimulating Hormone (recFSH). Period two consists of mothers (N = 541) who enrolled in trial P05712. Period three consists of miscarried/stillborn fetuses and infants born in trial P05712.

Arm/Group Title	Mothers Corifollitropin Alfa 150 µg	Mothers recFSH 200 IU	Fetuses/Infants Corifollitropin Alfa 150 µg	Fetuses/Infants recFSH 200 IU
Arm/Group Description	Participants from the Base Trial P05787 (NCT00696800) who received a subcutaneous (SC) injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of human Chorion Gonadotropin (hCG); multiple daily SC injections of Ganirelix from Stimulation Day 5 to the day of hCG; a single dose of hCG (10,000 or 5,000 IU/USP) was administered when 3 follicles >= 17 mm were observed; and on the day of oocyte pick-up (OPU) daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the Base Trial were enrolled in Follow Up Trial P05712, where no study treatments were given, and pregnancy, delivery and neonatal outcome were monitored.	Participants from the Base Trial P05787 (NCT00696800) who received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix from Stimulation Day 5 to the day of hCG; single dose of hCG (10,000 or 5,000 IU/USP) was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the Base Trial were enrolled in Follow Up Trial P05712, where no study treatments were given, and pregnancy, delivery and neonatal outcome were monitored.	Fetuses and infants born in Follow Up Trial P05712 to mothers treated with Corifollitropin Alfa 150 µg in Base Trial P05787 (NCT00696800)	Fetuses and infants born in Follow Up Trial P05712 to mothers treated with recFSH 200 IU in Base Trial P05787 (NCT00696800)
Period Title: Mothers Base Trial P05787 (NCT00696800)
STARTED	757	752	0	0
Treated	756	750	0	0
Embryo Transfer	672	704	0	0
COMPLETED	295	286	0	0
NOT COMPLETED	462	466	0	0
Period Title: Mothers Base Trial P05787 (NCT00696800)
STARTED	274	267	0	0
COMPLETED	241	235	0	0
NOT COMPLETED	33	32	0	0
Period Title: Mothers Base Trial P05787 (NCT00696800)
STARTED	0	0	352	326
Live Born Infants	0	0	344	315
COMPLETED	0	0	305	284
NOT COMPLETED	0	0	47	42

Baseline Characteristics

Arm/Group Title	Mothers Corifollitropin Alfa 150 µg	Mothers recFSH 200 IU	Total
Arm/Group Description	Participants from the Base Trial P05787 (NCT00696800) who received a SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix from Stimulation Day 5 to the day of hCG; a single dose of hCG (10,000 or 5,000 IU/USP) was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the Base Trial were enrolled in Follow Up Trial P05712, where no study treatments were given, and pregnancy, delivery and neonatal outcome were monitored.	Participants from the Base Trial P05787 (NCT00696800) who received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix from Stimulation Day 5 to the day of hCG; single dose of hCG (10,000 or 5,000 IU/USP) was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the Base Trial were enrolled in Follow Up Trial P05712, where no study treatments were given, and pregnancy, delivery and neonatal outcome were monitored.	Total of all reporting groups
Overall Participants	274	267	541
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	31.4 (3.2)	31.3 (3.5)	31.3 (3.3)
Sex: Female, Male (Count of Participants)
Female	274 100%	267 100%	541 100%
Male	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

Title	Number of Mothers in Current Follow Up Trial Experiencing Adverse Events (AEs)
Description	An AE is any untoward medical occurrence in a trial participant administered a pharmaceutical product, and which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including laboratory finding), symptom, or disease temporally associated with the use of investigational medicinal product.
Time Frame	Up to one day following delivery (up to 1 year)

Outcome Measure Data

Analysis Population Description

Eligible Mothers from the Base Trial P05787 (NCT00696800) who enrolled in the Follow Up Trial P05712. Infants from Follow Up Trial P05712 were not analyzed in this outcome measure.

Arm/Group Title	Mothers Corifollitropin Alfa 150 µg	Mothers recFSH 200 IU
Arm/Group Description	Participants from the Base Trial P05787 (NCT00696800) who received a SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix from Stimulation Day 5 to the day of hCG; a single dose of hCG (10,000 or 5,000 IU/USP) was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the Base Trial were enrolled in Follow Up Trial P05712, where no study treatments were given, and pregnancy, delivery and neonatal outcome were monitored.	Participants from the Base Trial P05787 (NCT00696800) who received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix from Stimulation Day 5 to the day of hCG; single dose of hCG (10,000 or 5,000 IU/USP) was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the Base Trial were enrolled in Follow Up Trial P05712, where no study treatments were given, and pregnancy, delivery and neonatal outcome were monitored.
Measure Participants	274	267
Number [Participants]	222 81%	214 80.1%

2. Primary Outcome

Title	Number of Mothers in Current Follow Up Trial Experiencing Serious AEs (SAEs)
Description	A SAE is any untoward medical occurrence that at any dose resulted in the following: death, was life threatening, required in-patient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, or was a congenital anomaly/birth defect.
Time Frame	Up to one day following delivery (up to 1 year)

Outcome Measure Data

Analysis Population Description

Eligible Mothers from the Base Trial P05787 (NCT00696800) who enrolled in the Follow Up Trial P05712. Infants from Follow Up Trial P05712 were not analyzed in this outcome measure.

Arm/Group Title	Mothers Corifollitropin Alfa 150 µg	Mothers recFSH 200 IU
Arm/Group Description	Participants from the Base Trial P05787 (NCT00696800) who received a SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix from Stimulation Day 5 to the day of hCG; a single dose of hCG (10,000 or 5,000 IU/USP) was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the Base Trial were enrolled in Follow Up Trial P05712, where no study treatments were given, and pregnancy, delivery and neonatal outcome were monitored.	Participants from the Base Trial P05787 (NCT00696800) who received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix from Stimulation Day 5 to the day of hCG; single dose of hCG (10,000 or 5,000 IU/USP) was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the Base Trial were enrolled in Follow Up Trial P05712, where no study treatments were given, and pregnancy, delivery and neonatal outcome were monitored.
Measure Participants	274	267
Number [Participants]	129 47.1%	117 43.8%

3. Primary Outcome

Title	Number of Infants Born in Current Follow Up Trial Experiencing AEs
Description	An AE is any untoward medical occurrence in a trial participant administered a pharmaceutical product, and which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including laboratory finding), symptom, or disease temporally associated with the use of investigational medicinal product.
Time Frame	Up to 12 weeks following delivery (up to 1 year)

Outcome Measure Data

Analysis Population Description

Infants born in Follow Up Trial P05712. Mothers were not analyzed in this outcome measure.

Arm/Group Title	Infants Corifollitropin Alfa 150 µg	Infants recFSH 200 IU
Arm/Group Description	Infants born in Follow Up Trial P05712 to mothers treated with Corifollitropin Alfa 150 µg in Base Trial P05787 (NCT00696800)	Infants born in Follow Up Trial P05712 to mothers treated with recFSH 200 IU in Base Trial P05787 (NCT00696800)
Measure Participants	344	315
Number [Participants]	164 59.9%	161 60.3%

4. Primary Outcome

Title	Number of Infants in Current Follow Up Trial Experiencing SAEs
Description	A SAE is any untoward medical occurrence that at any dose resulted in the following: death, was life threatening, required in-patient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, or was a congenital anomaly/birth defect.
Time Frame	Up to 12 weeks following delivery (up to 1 year)

Outcome Measure Data

Analysis Population Description

Infants born in Follow Up Trial P05712. Mothers were not analyzed in this outcome measure.

Arm/Group Title	Infants Corifollitropin Alfa 150 µg	Infants recFSH 200 IU
Arm/Group Description	Infants born in Follow Up Trial P05712 to mothers treated with Corifollitropin Alfa 150 µg in Base Trial P05787 (NCT00696800)	Infants born in Follow Up Trial P05712 to mothers treated with recFSH 200 IU in Base Trial P05787 (NCT00696800)
Measure Participants	344	315
Number [Participants]	106 38.7%	94 35.2%

5. Primary Outcome

Title	Percentage of Mothers From the Base Trial P05787 With at Least One Live Born Infant (Take-home Baby Rate) Relative to the Number of Participants in the Base Trial.
Description	The take-home baby rate is 100 X the number of participants with an ongoing pregnancy in Base Trial P05787 (NCT00696800), from the Intent-to-Treat (ITT) group, with at least one live born infant relative to the number of participants in the Base Trial.
Time Frame	At least 10 weeks after embryo transfer in Base Trial P05787 up to birth in current follow up Trial (up to 1 year)

Outcome Measure Data

Analysis Population Description

Mothers from the ITT group of the Base Trial P05787 (NCT00696800). Infants from Follow Up Trial P05712 were not analyzed in this outcome measure.

Arm/Group Title	Mothers Corifollitropin Alfa 150 µg	Mothers recFSH 200 IU
Arm/Group Description	Participants from the Base Trial P05787 (NCT00696800) who received a SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix from Stimulation Day 5 to the day of hCG; a single dose of hCG (10,000 or 5,000 IU/USP) was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the Base Trial were enrolled in Follow Up Trial P05712, where no study treatments were given, and pregnancy, delivery and neonatal outcome were monitored.	Participants from the Base Trial P05787 (NCT00696800) who received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix from Stimulation Day 5 to the day of hCG; single dose of hCG (10,000 or 5,000 IU/USP) was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the Base Trial were enrolled in Follow Up Trial P05712, where no study treatments were given, and pregnancy, delivery and neonatal outcome were monitored.
Measure Participants	756	750
Number [Percentage of Participants]	35.6 13%	34.4 12.9%

6. Primary Outcome

Title	Percentage of Mothers From the Base Trial P05787 With at Least One Live Born Infant (Take-home Baby Rate) Relative to the Number of Participants From the Base Trial With Embryo Transfer.
Description	The take-home baby rate is 100 X the number of participants with an ongoing pregnancy in Base Trial P05787 (NCT00696800), from the ITT group, with at least one live born infant relative to the number of participants from the Base Trial with embryo transfer.
Time Frame	At least 10 weeks after embryo transfer in Base Trial P05787 up to birth in current Follow Up Trial (up to 1 year)

Outcome Measure Data

Analysis Population Description

Mothers from the ITT group of the Base Trial P05787 (NCT00696800) who had ET. Infants from Follow Up Trial P05712 were not analyzed in this outcome measure.

Arm/Group Title	Mothers Corifollitropin Alfa 150 µg	Mothers recFSH 200 IU
Arm/Group Description	Participants from the Base Trial P05787 (NCT00696800) who received a SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix from Stimulation Day 5 to the day of hCG; a single dose of hCG (10,000 or 5,000 IU/USP) was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the Base Trial were enrolled in Follow Up Trial P05712, where no study treatments were given, and pregnancy, delivery and neonatal outcome were monitored.	Participants from the Base Trial P05787 (NCT00696800) who received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix from Stimulation Day 5 to the day of hCG; single dose of hCG (10,000 or 5,000 IU/USP) was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the Base Trial were enrolled in Follow Up Trial P05712, where no study treatments were given, and pregnancy, delivery and neonatal outcome were monitored.
Measure Participants	672	704
Number [Percentage of Participants]	40.0 14.6%	36.6 13.7%

Adverse Events

Time Frame	Mothers: up to one day after delivery; Fetuses and Infants: up to 12 weeks after birth
Adverse Event Reporting Description	All study treatments were considered to be administered to the mother.
Arm/Group Title	Mothers Corifollitropin Alfa 150 µg		Mothers recFSH 200 IU		Fetuses/Infants Corifollitropin Alfa 150 µg		Fetuses/Infants recFSH 200 IU
Arm/Group Description	Participants from the Base Trial P05787 (NCT00696800) who received a SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix from Stimulation Day 5 to the day of hCG; a single dose of hCG (10,000 or 5,000 IU/USP) was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the Base Trial were enrolled in Follow Up Trial P05712, where no study treatments were given, and pregnancy, delivery and neonatal outcome were monitored.		Participants from the Base Trial P05787 (NCT00696800) who received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix from Stimulation Day 5 to the day of hCG; single dose of hCG (10,000 or 5,000 IU/USP) was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the Base Trial were enrolled in Follow Up Trial P05712, where no study treatments were given, and pregnancy, delivery and neonatal outcome were monitored.		Fetuses and infants born in Follow Up Trial P05712 to mothers treated with Corifollitropin Alfa 150 µg in Base Trial P05787 (NCT00696800)		Fetuses and infants born in Follow Up Trial P05712 to mothers treated with recFSH 200 IU in Base Trial P05787 (NCT00696800)
All Cause Mortality
	Mothers Corifollitropin Alfa 150 µg		Mothers recFSH 200 IU		Fetuses/Infants Corifollitropin Alfa 150 µg		Fetuses/Infants recFSH 200 IU
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Mothers Corifollitropin Alfa 150 µg		Mothers recFSH 200 IU		Fetuses/Infants Corifollitropin Alfa 150 µg		Fetuses/Infants recFSH 200 IU
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	129/274 (47.1%)		117/267 (43.8%)		106/352 (30.1%)		94/326 (28.8%)
Blood and lymphatic system disorders
Anaemia neonatal	0/274 (0%)	0	0/267 (0%)	0	6/352 (1.7%)	6	3/326 (0.9%)	3
Haemorrhagic anaemia	1/274 (0.4%)	1	0/267 (0%)	0	0/352 (0%)	0	0/326 (0%)	0
Placental transfusion syndrome	0/274 (0%)	0	2/267 (0.7%)	2	0/352 (0%)	0	0/326 (0%)	0
Splenomegaly	0/274 (0%)	0	0/267 (0%)	0	0/352 (0%)	0	1/326 (0.3%)	1
Thrombocytopenia	0/274 (0%)	0	1/267 (0.4%)	1	0/352 (0%)	0	0/326 (0%)	0
Thrombocytopenia neonatal	0/274 (0%)	0	0/267 (0%)	0	1/352 (0.3%)	1	1/326 (0.3%)	1
Cardiac disorders
Bradycardia foetal	1/274 (0.4%)	1	1/267 (0.4%)	1	0/352 (0%)	0	0/326 (0%)	0
Bradycardia neonatal	0/274 (0%)	0	0/267 (0%)	0	0/352 (0%)	0	3/326 (0.9%)	3
Cardiac arrest	0/274 (0%)	0	0/267 (0%)	0	1/352 (0.3%)	1	0/326 (0%)	0
Cardiac hypertrophy	0/274 (0%)	0	0/267 (0%)	0	0/352 (0%)	0	1/326 (0.3%)	1
Cardio-respiratory arrest neonatal	0/274 (0%)	0	0/267 (0%)	0	1/352 (0.3%)	1	0/326 (0%)	0
Myocardial ischaemia	0/274 (0%)	0	0/267 (0%)	0	1/352 (0.3%)	1	0/326 (0%)	0
Nodal rhythm	0/274 (0%)	0	0/267 (0%)	0	0/352 (0%)	0	1/326 (0.3%)	1
Pulmonary valve stenosis	0/274 (0%)	0	0/267 (0%)	0	0/352 (0%)	0	1/326 (0.3%)	1
Tachycardia	0/274 (0%)	0	0/267 (0%)	0	1/352 (0.3%)	1	0/326 (0%)	0
Tachycardia foetal	1/274 (0.4%)	1	2/267 (0.7%)	2	0/352 (0%)	0	0/326 (0%)	0
Congenital, familial and genetic disorders
Abnormal palmar/planta creases	0/274 (0%)	0	0/267 (0%)	0	1/352 (0.3%)	1	0/326 (0%)	0
Accessory auricle	0/274 (0%)	0	0/267 (0%)	0	1/352 (0.3%)	1	1/326 (0.3%)	1
Ankyloglossia congenital	0/274 (0%)	0	0/267 (0%)	0	1/352 (0.3%)	1	1/326 (0.3%)	1
Atrial septal defect	0/274 (0%)	0	0/267 (0%)	0	5/352 (1.4%)	5	11/326 (3.4%)	11
Atrioventricular septal defect	0/274 (0%)	0	0/267 (0%)	0	0/352 (0%)	0	1/326 (0.3%)	1
Bat ear	0/274 (0%)	0	0/267 (0%)	0	1/352 (0.3%)	1	1/326 (0.3%)	1
Cervical rib	0/274 (0%)	0	0/267 (0%)	0	1/352 (0.3%)	1	0/326 (0%)	0
Chondrodystrophy	0/274 (0%)	0	0/267 (0%)	0	0/352 (0%)	0	1/326 (0.3%)	1
Cleft lip	0/274 (0%)	0	0/267 (0%)	0	1/352 (0.3%)	1	0/326 (0%)	0
Cleft palate	0/274 (0%)	0	0/267 (0%)	0	2/352 (0.6%)	2	1/326 (0.3%)	1
Cleft uvula	0/274 (0%)	0	0/267 (0%)	0	0/352 (0%)	0	1/326 (0.3%)	1
Clinodactyly	0/274 (0%)	0	0/267 (0%)	0	1/352 (0.3%)	1	0/326 (0%)	0
Congenital anaemia	0/274 (0%)	0	0/267 (0%)	0	1/352 (0.3%)	1	0/326 (0%)	0
Congenital aortic anomaly	0/274 (0%)	0	0/267 (0%)	0	1/352 (0.3%)	1	0/326 (0%)	0
Congenital aortic stenosis	0/274 (0%)	0	0/267 (0%)	0	1/352 (0.3%)	1	0/326 (0%)	0
Congenital aortic valve stenosis	0/274 (0%)	0	0/267 (0%)	0	1/352 (0.3%)	1	0/326 (0%)	0
Congenital central nervous system anomaly	0/274 (0%)	0	0/267 (0%)	0	3/352 (0.9%)	3	0/326 (0%)	0
Congenital cerebral cyst	0/274 (0%)	0	0/267 (0%)	0	1/352 (0.3%)	1	0/326 (0%)	0
Congenital choroid plexus cyst	0/274 (0%)	0	0/267 (0%)	0	0/352 (0%)	0	3/326 (0.9%)	3
Congenital coronary artery malformation	0/274 (0%)	0	0/267 (0%)	0	0/352 (0%)	0	1/326 (0.3%)	1
Congenital cyst	0/274 (0%)	0	0/267 (0%)	0	0/352 (0%)	0	1/326 (0.3%)	1
Congenital eyelid malformation	0/274 (0%)	0	0/267 (0%)	0	1/352 (0.3%)	1	1/326 (0.3%)	1
Congenital foot malformation	0/274 (0%)	0	0/267 (0%)	0	0/352 (0%)	0	1/326 (0.3%)	1
Congenital hand malformation	0/274 (0%)	0	0/267 (0%)	0	0/352 (0%)	0	1/326 (0.3%)	1
Congenital hearing disorder	0/274 (0%)	0	0/267 (0%)	0	1/352 (0.3%)	1	0/326 (0%)	0
Congenital hip deformity	0/274 (0%)	0	0/267 (0%)	0	0/352 (0%)	0	3/326 (0.9%)	3
Congenital hydrocephalus	0/274 (0%)	0	0/267 (0%)	0	1/352 (0.3%)	1	1/326 (0.3%)	1
Congenital inguinal hernia	0/274 (0%)	0	0/267 (0%)	0	1/352 (0.3%)	1	0/326 (0%)	0
Congenital labia pudendi adhesions	0/274 (0%)	0	0/267 (0%)	0	0/352 (0%)	0	1/326 (0.3%)	1
Congenital mitral valve stenosis	0/274 (0%)	0	0/267 (0%)	0	1/352 (0.3%)	1	0/326 (0%)	0
Congenital naevus	0/274 (0%)	0	0/267 (0%)	0	0/352 (0%)	0	3/326 (0.9%)	3
Congenital nose malformation	0/274 (0%)	0	0/267 (0%)	0	0/352 (0%)	0	1/326 (0.3%)	1
Congenital optic nerve anomaly	0/274 (0%)	0	0/267 (0%)	0	1/352 (0.3%)	1	0/326 (0%)	0
Congenital ovarian anomaly	0/274 (0%)	0	0/267 (0%)	0	0/352 (0%)	0	1/326 (0.3%)	1
Congenital pyelocaliectasis	0/274 (0%)	0	0/267 (0%)	0	0/352 (0%)	0	2/326 (0.6%)	2
Congenital spinal cord anomaly	0/274 (0%)	0	0/267 (0%)	0	1/352 (0.3%)	1	0/326 (0%)	0
Congenital torticollis	0/274 (0%)	0	0/267 (0%)	0	0/352 (0%)	0	1/326 (0.3%)	1
Congenital tracheomalacia	0/274 (0%)	0	0/267 (0%)	0	0/352 (0%)	0	1/326 (0.3%)	1
Craniotabes	0/274 (0%)	0	0/267 (0%)	0	0/352 (0%)	0	1/326 (0.3%)	1
Cryptorchism	0/274 (0%)	0	0/267 (0%)	0	1/352 (0.3%)	1	2/326 (0.6%)	2
Dacryostenosis congenital	0/274 (0%)	0	0/267 (0%)	0	3/352 (0.9%)	3	4/326 (1.2%)	4
Duodenal atresia	0/274 (0%)	0	0/267 (0%)	0	0/352 (0%)	0	1/326 (0.3%)	1
Exomphalos	0/274 (0%)	0	0/267 (0%)	0	7/352 (2%)	7	3/326 (0.9%)	3
Eyelid ptosis congenital	0/274 (0%)	0	0/267 (0%)	0	1/352 (0.3%)	1	0/326 (0%)	0
Fallot's tetralogy	0/274 (0%)	0	0/267 (0%)	0	1/352 (0.3%)	1	0/326 (0%)	0
Gastrointestinal malformation	0/274 (0%)	0	0/267 (0%)	0	0/352 (0%)	0	1/326 (0.3%)	1
Haemangioma congenital	0/274 (0%)	0	0/267 (0%)	0	4/352 (1.1%)	4	3/326 (0.9%)	3
Heart disease congenital	0/274 (0%)	0	0/267 (0%)	0	1/352 (0.3%)	1	0/326 (0%)	0
Hip dysplasia	0/274 (0%)	0	0/267 (0%)	0	4/352 (1.1%)	4	1/326 (0.3%)	1
Hypertelorism of orbit	0/274 (0%)	0	0/267 (0%)	0	1/352 (0.3%)	1	0/326 (0%)	0
Hypospadias	0/274 (0%)	0	0/267 (0%)	0	1/352 (0.3%)	1	1/326 (0.3%)	1
Immunodeficiency congenital	0/274 (0%)	0	0/267 (0%)	0	0/352 (0%)	0	1/326 (0.3%)	1
Patent ductus arteriosus	0/274 (0%)	0	0/267 (0%)	0	5/352 (1.4%)	5	6/326 (1.8%)	6
Phimosis	0/274 (0%)	0	0/267 (0%)	0	1/352 (0.3%)	1	0/326 (0%)	0
Pilonidal cyst congenital	0/274 (0%)	0	0/267 (0%)	0	3/352 (0.9%)	3	2/326 (0.6%)	2
Plagiocephaly	0/274 (0%)	0	0/267 (0%)	0	2/352 (0.6%)	2	1/326 (0.3%)	1
Pulmonary artery stenosis congenital	0/274 (0%)	0	0/267 (0%)	0	2/352 (0.6%)	2	1/326 (0.3%)	1
Pulmonary valve stenosis congenital	0/274 (0%)	0	0/267 (0%)	0	2/352 (0.6%)	2	1/326 (0.3%)	1
Pyloric stenosis	0/274 (0%)	0	0/267 (0%)	0	2/352 (0.6%)	2	1/326 (0.3%)	1
Rhesus haemolytic disease of newborn	0/274 (0%)	0	0/267 (0%)	0	0/352 (0%)	0	1/326 (0.3%)	1
Single umbilical artery	0/274 (0%)	0	0/267 (0%)	0	1/352 (0.3%)	1	0/326 (0%)	0
Skull malformation	0/274 (0%)	0	0/267 (0%)	0	1/352 (0.3%)	1	1/326 (0.3%)	1
Strabismus congenital	0/274 (0%)	0	0/267 (0%)	0	0/352 (0%)	0	1/326 (0.3%)	1
Supernumerary nipple	0/274 (0%)	0	0/267 (0%)	0	1/352 (0.3%)	1	0/326 (0%)	0
Syndactyly	0/274 (0%)	0	0/267 (0%)	0	2/352 (0.6%)	2	0/326 (0%)	0
Talipes	0/274 (0%)	0	0/267 (0%)	0	1/352 (0.3%)	1	2/326 (0.6%)	2
Tracheo-oesophageal fistula	0/274 (0%)	0	0/267 (0%)	0	1/352 (0.3%)	1	0/326 (0%)	0
Trisomy 21	0/274 (0%)	0	0/267 (0%)	0	0/352 (0%)	0	2/326 (0.6%)	2
Ventricular septal defect	0/274 (0%)	0	0/267 (0%)	0	0/352 (0%)	0	6/326 (1.8%)	6
Ear and labyrinth disorders
Hearing impaired	0/274 (0%)	0	0/267 (0%)	0	0/352 (0%)	0	1/326 (0.3%)	1
Hypoacusis	0/274 (0%)	0	0/267 (0%)	0	1/352 (0.3%)	1	0/326 (0%)	0
Endocrine disorders
Secondary hypogonadism	0/274 (0%)	0	0/267 (0%)	0	1/352 (0.3%)	1	0/326 (0%)	0
Eye disorders
Dacryostenosis acquired	0/274 (0%)	0	0/267 (0%)	0	5/352 (1.4%)	5	2/326 (0.6%)	2
Eye disorder	0/274 (0%)	0	1/267 (0.4%)	1	0/352 (0%)	0	0/326 (0%)	0
Lacrimal cyst	0/274 (0%)	0	0/267 (0%)	0	1/352 (0.3%)	1	0/326 (0%)	0
Retinopathy of prematurity	0/274 (0%)	0	0/267 (0%)	0	2/352 (0.6%)	2	1/326 (0.3%)	1
Gastrointestinal disorders
Anal stenosis	0/274 (0%)	0	0/267 (0%)	0	1/352 (0.3%)	1	0/326 (0%)	0
Diarrhoea	0/274 (0%)	0	1/267 (0.4%)	1	0/352 (0%)	0	0/326 (0%)	0
Dysphagia	0/274 (0%)	0	0/267 (0%)	0	1/352 (0.3%)	1	0/326 (0%)	0
Gastrooesophageal reflux disease	0/274 (0%)	0	0/267 (0%)	0	1/352 (0.3%)	1	1/326 (0.3%)	1
Inguinal hernia	0/274 (0%)	0	0/267 (0%)	0	1/352 (0.3%)	1	1/326 (0.3%)	1
Intestinal perforation	0/274 (0%)	0	0/267 (0%)	0	1/352 (0.3%)	1	0/326 (0%)	0
Necrotising enterocolitis neonatal	0/274 (0%)	0	0/267 (0%)	0	0/352 (0%)	0	2/326 (0.6%)	2
Short-bowel syndrome	0/274 (0%)	0	0/267 (0%)	0	0/352 (0%)	0	1/326 (0.3%)	1
General disorders
Death	0/274 (0%)	0	0/267 (0%)	0	0/352 (0%)	0	1/326 (0.3%)	1
Drug withdrawal syndrome neonatal	0/274 (0%)	0	0/267 (0%)	0	0/352 (0%)	0	1/326 (0.3%)	1
Fever neonatal	0/274 (0%)	0	0/267 (0%)	0	1/352 (0.3%)	1	1/326 (0.3%)	1
Inflammation	0/274 (0%)	0	0/267 (0%)	0	1/352 (0.3%)	1	0/326 (0%)	0
Neonatal multi-organ faillure	0/274 (0%)	0	0/267 (0%)	0	0/352 (0%)	0	1/326 (0.3%)	1
Sudden infant death syndrome	0/274 (0%)	0	0/267 (0%)	0	1/352 (0.3%)	1	1/326 (0.3%)	1
Hepatobiliary disorders
Hyperbilirubinaemia neonatal	0/274 (0%)	0	0/267 (0%)	0	9/352 (2.6%)	9	8/326 (2.5%)	8
Jaundice cholestatic	0/274 (0%)	0	0/267 (0%)	0	0/352 (0%)	0	1/326 (0.3%)	1
Neonatal cholestasis	0/274 (0%)	0	0/267 (0%)	0	1/352 (0.3%)	1	0/326 (0%)	0
Immune system disorders
Anaphylactic shock	1/274 (0.4%)	1	0/267 (0%)	0	0/352 (0%)	0	0/326 (0%)	0
Infections and infestations
Appendicitis	1/274 (0.4%)	1	0/267 (0%)	0	0/352 (0%)	0	0/326 (0%)	0
Bacterial sepsis	0/274 (0%)	0	0/267 (0%)	0	1/352 (0.3%)	1	0/326 (0%)	0
Genital herpes	1/274 (0.4%)	1	0/267 (0%)	0	0/352 (0%)	0	0/326 (0%)	0
Klebsiella sepsis	0/274 (0%)	0	0/267 (0%)	0	1/352 (0.3%)	1	0/326 (0%)	0
Incision site infection	1/274 (0.4%)	1	0/267 (0%)	0	0/352 (0%)	0	0/326 (0%)	0
Infection	0/274 (0%)	0	1/267 (0.4%)	1	0/352 (0%)	0	0/326 (0%)	0
Lobar pneumonia	1/274 (0.4%)	1	0/267 (0%)	0	0/352 (0%)	0	0/326 (0%)	0
Meningitis streptococcal	0/274 (0%)	0	0/267 (0%)	0	0/352 (0%)	0	1/326 (0.3%)	1
Neonatal infection	0/274 (0%)	0	0/267 (0%)	0	1/352 (0.3%)	1	1/326 (0.3%)	1
Neonatal pneumonia	0/274 (0%)	0	0/267 (0%)	0	0/352 (0%)	0	1/326 (0.3%)	1
Oral candidiasis	0/274 (0%)	0	0/267 (0%)	0	0/352 (0%)	0	1/326 (0.3%)	1
Respiratory syncytial virus bronchiolitis	0/274 (0%)	0	0/267 (0%)	0	1/352 (0.3%)	1	0/326 (0%)	0
Respiratory syncytial virus infection	0/274 (0%)	0	0/267 (0%)	0	0/352 (0%)	0	2/326 (0.6%)	2
Sepsis	0/274 (0%)	0	0/267 (0%)	0	0/352 (0%)	0	1/326 (0.3%)	1
Sepsis neonatal	0/274 (0%)	0	0/267 (0%)	0	7/352 (2%)	7	5/326 (1.5%)	5
Upper respiratory tract infection	0/274 (0%)	0	0/267 (0%)	0	0/352 (0%)	0	1/326 (0.3%)	1
Urinary tract infection	1/274 (0.4%)	1	1/267 (0.4%)	1	0/352 (0%)	0	0/326 (0%)	0
Viral infection	0/274 (0%)	0	0/267 (0%)	0	0/352 (0%)	0	1/326 (0.3%)	1
Injury, poisoning and procedural complications
Fall	1/274 (0.4%)	1	0/267 (0%)	0	0/352 (0%)	0	0/326 (0%)	0
Joint dislocation	1/274 (0.4%)	1	0/267 (0%)	0	0/352 (0%)	0	0/326 (0%)	0
Post procedural haemorrhage	0/274 (0%)	0	1/267 (0.4%)	1	0/352 (0%)	0	0/326 (0%)	0
Rib fracture	0/274 (0%)	0	0/267 (0%)	0	0/352 (0%)	0	1/326 (0.3%)	1
Investigations
Acoustic stimulation tests abnormal	0/274 (0%)	0	0/267 (0%)	0	0/352 (0%)	0	2/326 (0.6%)	2
Amniotic fluid volume decreased	1/274 (0.4%)	1	0/267 (0%)	0	0/352 (0%)	0	0/326 (0%)	0
Blood glucose decreased	0/274 (0%)	0	0/267 (0%)	0	0/352 (0%)	0	1/326 (0.3%)	1
Blood glucose fluctuation	0/274 (0%)	0	0/267 (0%)	0	0/352 (0%)	0	1/326 (0.3%)	1
Blood sodium increased	0/274 (0%)	0	0/267 (0%)	0	1/352 (0.3%)	1	0/326 (0%)	0
Body temperature decreased	0/274 (0%)	0	0/267 (0%)	0	1/352 (0.3%)	1	0/326 (0%)	0
C-reactive protein increased	0/274 (0%)	0	0/267 (0%)	0	2/352 (0.6%)	2	0/326 (0%)	0
Cardiac murmur	0/274 (0%)	0	0/267 (0%)	0	6/352 (1.7%)	6	3/326 (0.9%)	3
Cytomegalovirus antibody positive	0/274 (0%)	0	0/267 (0%)	0	0/352 (0%)	0	1/326 (0.3%)	1
Foetal heart rate abnormal	3/274 (1.1%)	3	2/267 (0.7%)	2	2/352 (0.6%)	2	0/326 (0%)	0
Foetal heart rate decreased	1/274 (0.4%)	1	2/267 (0.7%)	2	0/352 (0%)	0	0/326 (0%)	0
Haemoglobin Barts present	0/274 (0%)	0	0/267 (0%)	0	0/352 (0%)	0	1/326 (0.3%)	1
Heart rate decreased	0/274 (0%)	0	0/267 (0%)	0	1/352 (0.3%)	1	0/326 (0%)	0
Hepatic enzyme increased	1/274 (0.4%)	1	0/267 (0%)	0	0/352 (0%)	0	0/326 (0%)	0
Metabolism and nutrition disorders
Cow's milk intolerance	0/274 (0%)	0	0/267 (0%)	0	1/352 (0.3%)	1	0/326 (0%)	0
Dehydration	0/274 (0%)	0	0/267 (0%)	0	0/352 (0%)	0	1/326 (0.3%)	1
Fatty acid deficiency	0/274 (0%)	0	0/267 (0%)	0	0/352 (0%)	0	1/326 (0.3%)	1
Gestational diabetes	1/274 (0.4%)	1	0/267 (0%)	0	0/352 (0%)	0	0/326 (0%)	0
Hyperglycaemia	0/274 (0%)	0	0/267 (0%)	0	0/352 (0%)	0	3/326 (0.9%)	3
Hypermagnesaemia	0/274 (0%)	0	0/267 (0%)	0	0/352 (0%)	0	3/326 (0.9%)	3
Hypocalcaemia	0/274 (0%)	0	0/267 (0%)	0	0/352 (0%)	0	1/326 (0.3%)	1
Hypoglycaemia neonatal	0/274 (0%)	0	0/267 (0%)	0	3/352 (0.9%)	3	3/326 (0.9%)	3
Loctose intolerance	0/274 (0%)	0	0/267 (0%)	0	0/352 (0%)	0	1/326 (0.3%)	1
Metabolic acidosis	0/274 (0%)	0	0/267 (0%)	0	1/352 (0.3%)	1	0/326 (0%)	0
Neonatal hyponatraemia	0/274 (0%)	0	0/267 (0%)	0	0/352 (0%)	0	3/326 (0.9%)	3
Musculoskeletal and connective tissue disorders
Back pain	1/274 (0.4%)	1	0/267 (0%)	0	0/352 (0%)	0	0/326 (0%)	0
Head deformity	0/274 (0%)	0	0/267 (0%)	0	1/352 (0.3%)	1	0/326 (0%)	0
Hypotonia neonatal	0/274 (0%)	0	0/267 (0%)	0	0/352 (0%)	0	1/326 (0.3%)	1
Joint range of motion decreased	0/274 (0%)	0	0/267 (0%)	0	2/352 (0.6%)	2	0/326 (0%)	0
Osteopenia	0/274 (0%)	0	0/267 (0%)	0	0/352 (0%)	0	1/326 (0.3%)	1
Positional plagiocephaly	0/274 (0%)	0	0/267 (0%)	0	1/352 (0.3%)	1	0/326 (0%)	0
Posture abnormal	0/274 (0%)	0	0/267 (0%)	0	1/352 (0.3%)	1	0/326 (0%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma	0/274 (0%)	0	0/267 (0%)	0	0/352 (0%)	0	1/326 (0.3%)	1
Haemangioma of skin	0/274 (0%)	0	0/267 (0%)	0	0/352 (0%)	0	1/326 (0.3%)	1
Lymphangioma	0/274 (0%)	0	0/267 (0%)	0	0/352 (0%)	0	1/326 (0.3%)	1
Nervous system disorders
Brain oedema	0/274 (0%)	0	0/267 (0%)	0	0/352 (0%)	0	1/326 (0.3%)	1
Cerebral haemorrhage neonatal	0/274 (0%)	0	0/267 (0%)	0	1/352 (0.3%)	1	0/326 (0%)	0
Cerebral infarction	1/274 (0.4%)	1	0/267 (0%)	0	0/352 (0%)	0	0/326 (0%)	0
Cerebral ventricle dilatation	0/274 (0%)	0	0/267 (0%)	0	0/352 (0%)	0	1/326 (0.3%)	1
Convulsion neonatal	0/274 (0%)	0	0/267 (0%)	0	2/352 (0.6%)	2	0/326 (0%)	0
Dizziness	1/274 (0.4%)	1	0/267 (0%)	0	0/352 (0%)	0	0/326 (0%)	0
Encephalopathy neonatal	0/274 (0%)	0	0/267 (0%)	0	1/352 (0.3%)	1	0/326 (0%)	0
Intraventricular haemorrhage neonatal	0/274 (0%)	0	0/267 (0%)	0	0/352 (0%)	0	2/326 (0.6%)	2
Neurological symptom	0/274 (0%)	0	0/267 (0%)	0	1/352 (0.3%)	1	0/326 (0%)	0
Superior sagittal sinus thrombosis	1/274 (0.4%)	1	0/267 (0%)	0	0/352 (0%)	0	0/326 (0%)	0
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous	2/274 (0.7%)	2	2/267 (0.7%)	2	0/352 (0%)	0	0/326 (0%)	0
Antepartum haemorrhage	2/274 (0.7%)	2	0/267 (0%)	0	0/352 (0%)	0	0/326 (0%)	0
Arrested labour	12/274 (4.4%)	12	15/267 (5.6%)	15	0/352 (0%)	0	0/326 (0%)	0
Breech presentation	26/274 (9.5%)	26	23/267 (8.6%)	23	0/352 (0%)	0	0/326 (0%)	0
Caput succedaneum	0/274 (0%)	0	1/267 (0.4%)	1	0/352 (0%)	0	0/326 (0%)	0
Cephalo-pelvic disproportion	5/274 (1.8%)	5	3/267 (1.1%)	3	0/352 (0%)	0	0/326 (0%)	0
Cervical incompetence	4/274 (1.5%)	4	1/267 (0.4%)	1	0/352 (0%)	0	0/326 (0%)	0
Chorioamnionitis	1/274 (0.4%)	1	1/267 (0.4%)	1	0/352 (0%)	0	0/326 (0%)	0
Discordant twin	0/274 (0%)	0	0/267 (0%)	0	2/352 (0.6%)	2	2/326 (0.6%)	2
Face presentation	1/274 (0.4%)	1	1/267 (0.4%)	1	0/352 (0%)	0	0/326 (0%)	0
Failed induction of labour	4/274 (1.5%)	4	2/267 (0.7%)	2	0/352 (0%)	0	0/326 (0%)	0
Foetal distress syndrome	6/274 (2.2%)	6	13/267 (4.9%)	13	1/352 (0.3%)	1	2/326 (0.6%)	2
Foetal growth retardation	4/274 (1.5%)	4	1/267 (0.4%)	1	0/352 (0%)	0	0/326 (0%)	0
Foetal hypokinesia	1/274 (0.4%)	1	0/267 (0%)	0	0/352 (0%)	0	0/326 (0%)	0
Foetal macrosomia	0/274 (0%)	0	1/267 (0.4%)	1	0/352 (0%)	0	0/326 (0%)	0
Foetal malposition	0/274 (0%)	0	1/267 (0.4%)	1	0/352 (0%)	0	0/326 (0%)	0
Foetal malpresentation	4/274 (1.5%)	4	4/267 (1.5%)	4	0/352 (0%)	0	0/326 (0%)	0
HELLP syndrome	2/274 (0.7%)	2	0/267 (0%)	0	0/352 (0%)	0	0/326 (0%)	0
Hydrops foetalis	0/274 (0%)	0	0/267 (0%)	0	0/352 (0%)	0	1/326 (0.3%)	1
Hyperemesis gravidarum	0/274 (0%)	0	1/267 (0.4%)	1	0/352 (0%)	0	0/326 (0%)	0
Imminent abortion	1/274 (0.4%)	1	0/267 (0%)	0	0/352 (0%)	0	0/326 (0%)	0
Intrapartum haemorrhage	0/274 (0%)	0	1/267 (0.4%)	1	0/352 (0%)	0	0/326 (0%)	0
Jaundice neonatal	0/274 (0%)	0	0/267 (0%)	0	8/352 (2.3%)	8	8/326 (2.5%)	8
Meconium in amniotic fluid	0/274 (0%)	0	2/267 (0.7%)	2	0/352 (0%)	0	0/326 (0%)	0
Meconium stain	0/274 (0%)	0	2/267 (0.7%)	2	0/352 (0%)	0	0/326 (0%)	0
Multiple pregnancy	1/274 (0.4%)	1	0/267 (0%)	0	0/352 (0%)	0	0/326 (0%)	0
Oligohydramnios	1/274 (0.4%)	1	3/267 (1.1%)	3	0/352 (0%)	0	0/326 (0%)	0
Placenta accreta	0/274 (0%)	0	1/267 (0.4%)	1	0/352 (0%)	0	0/326 (0%)	0
Placenta praevia	5/274 (1.8%)	5	2/267 (0.7%)	2	0/352 (0%)	0	0/326 (0%)	0
Polyhydramnios	0/274 (0%)	0	1/267 (0.4%)	1	0/352 (0%)	0	0/326 (0%)	0
Postpartum haemorrhage	2/274 (0.7%)	2	0/267 (0%)	0	0/352 (0%)	0	0/326 (0%)	0
Pre-eclampsia	12/274 (4.4%)	12	10/267 (3.7%)	10	0/352 (0%)	0	0/326 (0%)	0
Pregnancy induced hypertension	4/274 (1.5%)	4	3/267 (1.1%)	3	0/352 (0%)	0	0/326 (0%)	0
Premature baby	0/274 (0%)	0	0/267 (0%)	0	56/352 (15.9%)	56	48/326 (14.7%)	48
Premature labour	37/274 (13.5%)	37	33/267 (12.4%)	33	0/352 (0%)	0	0/326 (0%)	0
Premature rupture of membranes	8/274 (2.9%)	8	6/267 (2.2%)	6	0/352 (0%)	0	0/326 (0%)	0
Premature separation of placenta	6/274 (2.2%)	6	1/267 (0.4%)	1	0/352 (0%)	0	0/326 (0%)	0
Previous caesarean section	3/274 (1.1%)	3	2/267 (0.7%)	2	0/352 (0%)	0	0/326 (0%)	0
Prolonged labour	2/274 (0.7%)	2	1/267 (0.4%)	1	0/352 (0%)	0	0/326 (0%)	0
Small for dates baby	0/274 (0%)	0	0/267 (0%)	0	3/352 (0.9%)	3	6/326 (1.8%)	6
Stillbirth	1/274 (0.4%)	1	2/267 (0.7%)	2	0/352 (0%)	0	0/326 (0%)	0
Threatened labour	10/274 (3.6%)	10	11/267 (4.1%)	11	0/352 (0%)	0	0/326 (0%)	0
Transverse presentation	3/274 (1.1%)	3	3/267 (1.1%)	3	0/352 (0%)	0	0/326 (0%)	0
Twin pregnancy	16/274 (5.8%)	16	15/267 (5.6%)	15	0/352 (0%)	0	0/326 (0%)	0
Umbilical cord abnormality	0/274 (0%)	0	1/267 (0.4%)	1	0/352 (0%)	0	0/326 (0%)	0
Umbilical cord around neck	0/274 (0%)	0	0/267 (0%)	0	0/352 (0%)	0	1/326 (0.3%)	1
Umbilical cord prolapse	1/274 (0.4%)	1	2/267 (0.7%)	2	0/352 (0%)	0	0/326 (0%)	0
Uterine contractions during pregnancy	1/274 (0.4%)	1	0/267 (0%)	0	0/352 (0%)	0	0/326 (0%)	0
Uterine hypotonus	0/274 (0%)	0	1/267 (0.4%)	1	0/352 (0%)	0	0/326 (0%)	0
Psychiatric disorders
Agitation neonatal	0/274 (0%)	0	0/267 (0%)	0	1/352 (0.3%)	1	0/326 (0%)	0
Post-traumatic stress disorder	1/274 (0.4%)	1	0/267 (0%)	0	0/352 (0%)	0	0/326 (0%)	0
Renal and urinary disorders
Haematuria	0/274 (0%)	0	0/267 (0%)	0	1/352 (0.3%)	1	0/326 (0%)	0
Renal colic	1/274 (0.4%)	1	1/267 (0.4%)	1	0/352 (0%)	0	0/326 (0%)	0
Renal failure neonatal	0/274 (0%)	0	0/267 (0%)	0	1/352 (0.3%)	1	1/326 (0.3%)	1
Renal tubular necrosis	0/274 (0%)	0	0/267 (0%)	0	0/352 (0%)	0	1/326 (0.3%)	1
Reproductive system and breast disorders
Cervix oedema	0/274 (0%)	0	1/267 (0.4%)	1	0/352 (0%)	0	0/326 (0%)	0
Chordee	0/274 (0%)	0	0/267 (0%)	0	0/352 (0%)	0	1/326 (0.3%)	1
Haemorrhagic ovarian cyst	0/274 (0%)	0	1/267 (0.4%)	1	0/352 (0%)	0	0/326 (0%)	0
Ovarian enlargement	1/274 (0.4%)	1	0/267 (0%)	0	0/352 (0%)	0	0/326 (0%)	0
Ovarian hyperstimulation syndrome	1/274 (0.4%)	1	0/267 (0%)	0	0/352 (0%)	0	0/326 (0%)	0
Ovarian torsion	0/274 (0%)	0	1/267 (0.4%)	1	0/352 (0%)	0	0/326 (0%)	0
Pelvic pain	1/274 (0.4%)	1	0/267 (0%)	0	0/352 (0%)	0	0/326 (0%)	0
Shortened cervix	0/274 (0%)	0	2/267 (0.7%)	2	0/352 (0%)	0	0/326 (0%)	0
Uterine atony	1/274 (0.4%)	1	0/267 (0%)	0	0/352 (0%)	0	0/326 (0%)	0
Vaginal haemorrhage	1/274 (0.4%)	1	0/267 (0%)	0	0/352 (0%)	0	0/326 (0%)	0
Respiratory, thoracic and mediastinal disorders
Apnoea	0/274 (0%)	0	0/267 (0%)	0	1/352 (0.3%)	1	0/326 (0%)	0
Apparent life threatening event	0/274 (0%)	0	0/267 (0%)	0	1/352 (0.3%)	1	0/326 (0%)	0
Atelectasis neonatal	0/274 (0%)	0	0/267 (0%)	0	1/352 (0.3%)	1	0/326 (0%)	0
Bronchopulmonary dysplasia	0/274 (0%)	0	0/267 (0%)	0	0/352 (0%)	0	1/326 (0.3%)	1
Infantile apnoeic attack	0/274 (0%)	0	0/267 (0%)	0	2/352 (0.6%)	2	3/326 (0.9%)	3
Neonatal hypoxia	0/274 (0%)	0	0/267 (0%)	0	1/352 (0.3%)	1	1/326 (0.3%)	1
Neonatal respiratory distress syndrome	0/274 (0%)	0	0/267 (0%)	0	13/352 (3.7%)	13	12/326 (3.7%)	12
Neonatal respiratory failure	0/274 (0%)	0	0/267 (0%)	0	1/352 (0.3%)	1	4/326 (1.2%)	4
Neonatal tachypnoea	0/274 (0%)	0	0/267 (0%)	0	0/352 (0%)	0	1/326 (0.3%)	1
Pneumomediastinum	0/274 (0%)	0	0/267 (0%)	0	0/352 (0%)	0	1/326 (0.3%)	1
Pneumothorax	0/274 (0%)	0	0/267 (0%)	0	0/352 (0%)	0	2/326 (0.6%)	2
Pulmonary oedema	0/274 (0%)	0	2/267 (0.7%)	2	0/352 (0%)	0	0/326 (0%)	0
Respiratory disorder neonatal	0/274 (0%)	0	0/267 (0%)	0	1/352 (0.3%)	1	0/326 (0%)	0
Sleep apnoea syndrome	0/274 (0%)	0	0/267 (0%)	0	1/352 (0.3%)	1	0/326 (0%)	0
Transient tachypnoea of the newborn	0/274 (0%)	0	0/267 (0%)	0	0/352 (0%)	0	4/326 (1.2%)	4
Skin and subcutaneous tissue disorders
Hair growth abnormal	0/274 (0%)	0	0/267 (0%)	0	1/352 (0.3%)	1	0/326 (0%)	0
Pruritus	1/274 (0.4%)	1	0/267 (0%)	0	0/352 (0%)	0	0/326 (0%)	0
Surgical and medical procedures
Abortion induced	1/274 (0.4%)	1	1/267 (0.4%)	1	0/352 (0%)	0	0/326 (0%)	0
Appendicectomy	0/274 (0%)	0	0/267 (0%)	0	0/352 (0%)	0	1/326 (0.3%)	1
Caesarean section	0/274 (0%)	0	5/267 (1.9%)	5	0/352 (0%)	0	0/326 (0%)	0
Evacuation of retained products of conception	1/274 (0.4%)	1	0/267 (0%)	0	0/352 (0%)	0	0/326 (0%)	0
Labour induction	0/274 (0%)	0	1/267 (0.4%)	1	0/352 (0%)	0	0/326 (0%)	0
Selective abortion	0/274 (0%)	0	1/267 (0.4%)	1	0/352 (0%)	0	0/326 (0%)	0
Vascular disorders
Deep vein thrombosis	0/274 (0%)	0	1/267 (0.4%)	1	0/352 (0%)	0	0/326 (0%)	0
Hypertension neonatal	0/274 (0%)	0	0/267 (0%)	0	2/352 (0.6%)	2	0/326 (0%)	0
Hypoperfusion	0/274 (0%)	0	0/267 (0%)	0	0/352 (0%)	0	1/326 (0.3%)	1
Lymphocele	0/274 (0%)	0	0/267 (0%)	0	0/352 (0%)	0	1/326 (0.3%)	1
Neonatal hypotension	0/274 (0%)	0	0/267 (0%)	0	1/352 (0.3%)	1	1/326 (0.3%)	1
Other (Not Including Serious) Adverse Events
	Mothers Corifollitropin Alfa 150 µg		Mothers recFSH 200 IU		Fetuses/Infants Corifollitropin Alfa 150 µg		Fetuses/Infants recFSH 200 IU
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	112/274 (40.9%)		118/267 (44.2%)		37/352 (10.5%)		41/326 (12.6%)
Blood and lymphatic system disorders
Anaemia	20/274 (7.3%)	20	17/267 (6.4%)	17	0/352 (0%)	0	0/326 (0%)	0
Gastrointestinal disorders
Constipation	15/274 (5.5%)	16	22/267 (8.2%)	23	2/352 (0.6%)	2	8/326 (2.5%)	8
Dyspepsia	27/274 (9.9%)	31	22/267 (8.2%)	23	0/352 (0%)	0	0/326 (0%)	0
Gastrooesophageal reflux disease	6/274 (2.2%)	6	3/267 (1.1%)	3	16/352 (4.5%)	16	17/326 (5.2%)	17
Vomiting	20/274 (7.3%)	22	14/267 (5.2%)	15	0/352 (0%)	0	3/326 (0.9%)	3
Nausea	34/274 (12.4%)	38	27/267 (10.1%)	29	0/352 (0%)	0	2/326 (0.6%)	2
General disorders
Fatigue	17/274 (6.2%)	19	15/267 (5.6%)	17	0/352 (0%)	0	0/326 (0%)	0
Oedema Peripheral	21/274 (7.7%)	26	13/267 (4.9%)	16	0/352 (0%)	0	0/326 (0%)	0
Metabolism and nutrition disorders
Gestational diabetes	10/274 (3.6%)	10	14/267 (5.2%)	14	0/352 (0%)	0	0/326 (0%)	0
Musculoskeletal and connective tissue disorders
Back pain	25/274 (9.1%)	28	20/267 (7.5%)	25	0/352 (0%)	0	0/326 (0%)	0
Nervous system disorders
Headache	24/274 (8.8%)	31	31/267 (11.6%)	37	0/352 (0%)	0	0/326 (0%)	0
Pregnancy, puerperium and perinatal conditions
Antepartum haemorrhage	19/274 (6.9%)	21	14/267 (5.2%)	19	0/352 (0%)	0	0/326 (0%)	0
Jaundice neonatal	0/274 (0%)	0	0/267 (0%)	0	22/352 (6.3%)	22	20/326 (6.1%)	20
Threatened labour	18/274 (6.6%)	18	15/267 (5.6%)	15	0/352 (0%)	0	0/326 (0%)	0
Reproductive system and breast disorders
Pelvic pain	14/274 (5.1%)	18	10/267 (3.7%)	16	0/352 (0%)	0	0/326 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Any scientific paper, presentation, or other communication concerning the clinical trial will first be presented to the Sponsor, at least six weeks ahead of estimated publication or presentation, for written consent. The Sponsor shall have the right to make its consent conditional upon proper representation of the interpretation of both the Sponsor and the investigator(s) in the discussion of the data in such communications.