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

Study Overview
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Brief Summary
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The objective of this follow-up study is to evaluate whether corifollitropin alfa (Org 36286) 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) is safe for pregnant participants and their offspring.

Detailed Description
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This is a follow-up protocol to prospectively monitor pregnancy, delivery, and neonatal outcome of women who were treated with corifollitropin alfa or recFSH and became pregnant during the base study P05690 (NCT00702845). For this trial no study specific assessments are required, but information as obtained in standard practice will be used.

Official Title
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Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established After Controlled Ovarian Stimulation in Clinical Trial 107012 for the Development of Org 36286 (Corifollitropin Alfa)

Conditions
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Pregnancy, Neonates

Intervention / Treatment
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* 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)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants who participated in base study P05690 (NCT00702845) and received at least one dose of either corifollitropin alfa (Org 36286) or recFSH in base study P05690; Ongoing pregnancy confirmed by ultrasound at least 10 weeks after embryo transfer in base study P05690; Able and willing to give written informed consent. Exclusion Criteria: None

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 36 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Corifollitropin alfa 100 μg<br>In follow-up study, no medication or investigational product was administered. In base study P05690 (NCT00702845), participants received single subcutaneous (SC) injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of menstrual cycle and daily placebo-recombinant Follicle Stimulating Hormone (recFSH) injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants in base study P05690 also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of Human Chorion Gonadotropin (hCG) administration. Participants also received Gonadotropin Releasing Hormone (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). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day by intramuscular [IM] injection), starting on day of oocyte pick-up (OPU) and continuing for at least 6 weeks or up to menses. | Drug: Corifollitropin alfa<br>* Single injection of 100 μg corifollitropin alfa administered under protocol P05690<br>* Other names: MK-8962;Drug: gonadatropin releasing hormone (GnRH) antagonist ganirelix<br>* GnRH antagonist ganirelix administered SC at a dose of 0.25 mg/day under protocol P05690<br>Biological: human chorion gonadotropin (hCG)<br>* hCG 5,000 IU/USP or 10,000 IU/USP administered under protocol P05690<br>Biological: progesterone<br>* Under protocol P05690, progesterone was started on the day of oocyte pick-up (OPU) and continued for at least 6 weeks or up to menses. Participants received at least 600 mg/day vaginally or 50 mg/day IM.<br>Drug: placebo-recFSH (follitropin beta)<br>* Placebo-recFSH at the equivalent volume of 150 IU/day administered under protocol P05690<br>Biological: open-label recFSH (follitropin beta)<br>* Open-label recFSH up to a maximum dose of 200 IU/day, administered under protocol P05690<br>|
| recFSH 150 IU<br>In follow-up study, no medication or investigational product was administered. In base study P05690 (NCT00702845), participants in the reference group 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 Day of hCG (10,000 or 5,000 IU/USP) 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. 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. | Biological: recFSH (follitropin beta)<br>* Daily recFSH administered under protocol P05690<br>* Other names: Follistim®;Drug: gonadatropin releasing hormone (GnRH) antagonist ganirelix<br>* GnRH antagonist ganirelix administered SC at a dose of 0.25 mg/day under protocol P05690<br>Biological: human chorion gonadotropin (hCG)<br>* hCG 5,000 IU/USP or 10,000 IU/USP administered under protocol P05690<br>Biological: progesterone<br>* Under protocol P05690, progesterone was started on the day of oocyte pick-up (OPU) and continued for at least 6 weeks or up to menses. Participants received at least 600 mg/day vaginally or 50 mg/day IM.<br>Drug: placebo-corifollitropin alfa<br>* Single SC injection of placebo-corifollitropin alfa on Day 2 or 3 of the menstrual cycle, administered under protocol P05690<br>Biological: open-label recFSH (follitropin beta)<br>* Open-label recFSH up to a maximum dose of 200 IU/day, administered under protocol P05690<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Women With ≥1 Live Born Infant During Follow-up (Take-Home Baby Rate) | 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. | From approximately 10 weeks after ET in base study P05690 up to birth of infant (up to approximately 6 months) | 
| Number of Expectant Mothers Experiencing Adverse Events (AEs) | 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. | From approximately 10 weeks after ET in base study P05690 up to birth of infant (up to approximately 6 months) | 
| Number of Expectant Mothers Experiencing Serious AEs (SAEs) | 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. | From approximately 10 weeks after ET in base study P05690 up to birth of infant (up to approximately 6 months) | 
| Number of Infants Experiencing AEs | 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. | Up to 12 weeks after birth | 
| Number of Infants Experiencing SAEs | 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. | Up to 12 weeks after birth | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neonatal outcome, Congenital malformations, In-Vitro fertilization, Controlled ovarian stimulation, Follow-up