NCT00702195

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 29 (actual)
• Sponsor: Organon and Co · Industry
• Sex: Female
• Age: 18 Years – 39 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pregnancy

Interventions

Type	Name	Description
DRUG	Org 36286 (corifollitropin alfa)	single dose of Org 36286 (corifollitropin alfa) administered under protocol 38805/38807
DRUG	Placebo	single dose of placebo (administered under protocol 38805)
DRUG	recFSH	150 IU recFSH daily (reference group administered under protocol 38807)

Timeline

• Start date: 2002-01-01
• Primary completion: 2003-09-15
• Completion: 2003-09-15
• First posted: 2008-06-20
• Last updated: 2024-08-15