Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established During Phase II Clinical Trials of Org 36286 (Study 38817)(P06054)(COMPLETED)

Study Overview
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Brief Summary
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The objective of this trial was to evaluate whether Org 36286 treatment in any Phase IIa clinical development trial of Org 36286 for OI or COH in assisted reproductive treatment programs was safe for pregnant subjects and their offspring. Data from subjects who participated in Trials 38805 and 38807 and became pregnant were evaluated.

Detailed Description
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This was an open prospective follow-up trial to monitor pregnancy, delivery, and neonatal outcome of women who became pregnant during any Phase IIa clinical trial of Org 36286 for OI or COH for IVF. For this trial, no study specific assessments were required, but information obtained in standard practice was used.

Official Title
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Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established During Phase II Clinical Trials for the Development of Org 36286 (Corifollitropin Alfa).

Conditions
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Pregnancy

Intervention / Treatment
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* Drug: Org 36286 (corifollitropin alfa)
* Drug: Placebo
* Drug: recFSH


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects taking part in any clinical development trial of Org 36286 for OI or COH for IVF in Phase IIa; Ongoing pregnancy confirmed by ultrasonography (USS) at or beyond 12 weeks of gestation; 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: 39 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 |
| --- | --- |
| Experimental Group 1<br>all doses of Org 36286 (corifollitropin alfa) from trial 38805 (7.5 μg, 15 μg, 30 μg and 60 μg) | Drug: Org 36286 (corifollitropin alfa)<br>* single dose of Org 36286 (corifollitropin alfa) administered under protocol 38805/38807<br>* Other names: corifollitropin alfa;|
| Experimental Group 2<br>Placebo | Drug: Placebo<br>* single dose of placebo (administered under protocol 38805)<br>|
| Experimental Group 3<br>all doses of Org 36286 (corifollitropin alfa) from trial 38807 (120 μg, 180 μg and 240 μg) | Drug: Org 36286 (corifollitropin alfa)<br>* single dose of Org 36286 (corifollitropin alfa) administered under protocol 38805/38807<br>* Other names: corifollitropin alfa;|
| Experimental Group 4<br>150 IU Puregon® | Drug: recFSH<br>* 150 IU recFSH daily (reference group administered under protocol 38807)<br>* Other names: Follistim®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pregnancy status at 20 weeks of gestation; Take-home baby rate |  | one pregnancy period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pregnancy follow-up; Delivery follow-up; Neonatal outcome; Infant follow-up; Congenital Malformations and Chromosomal Abnormalities |  | one pregnancy period | 

 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, Ovulation Induction, Neonates