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

Completed

• Conditions: Pregnancy
• Interventions: Drug: Org 36286 (corifollitropin alfa); Drug: Placebo; Drug: recFSH

• Registration Number: NCT00702195
• Lead Sponsor: Organon and Co

Brief Summary

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

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.

Study Timeline

• Study Start: 2002-01-01
• Primary Completion: 2003-09-15
• Study Completion: 2003-09-15
• Study First Submitted: 2008-06-18
• Study First Submitted QC: 2008-06-19
• Study First Posted: 2008-06-20
• Status Verified: 2022-02
• Last Update Submitted: 2024-08-13
• Last Update Posted: 2024-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 29

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Experimental Group 1	Org 36286 (corifollitropin alfa)	all doses of Org 36286 (corifollitropin alfa) from trial 38805 (7.5 μg, 15 μg, 30 μg and 60 μg)
Experimental Group 2	Placebo	Placebo
Experimental Group 3	Org 36286 (corifollitropin alfa)	all doses of Org 36286 (corifollitropin alfa) from trial 38807 (120 μg, 180 μg and 240 μg)
Experimental Group 4	recFSH	150 IU Puregon®

Primary Outcome Measures

Name	Time	Method
Pregnancy status at 20 weeks of gestation; Take-home baby rate	one pregnancy period

Secondary Outcome Measures

Name	Time	Method
Pregnancy follow-up; Delivery follow-up; Neonatal outcome; Infant follow-up; Congenital Malformations and Chromosomal Abnormalities	one pregnancy period