NCT00702988

Pregnancy & Neonatal Follow-up of Ongoing Pregnancies Established During Clinical Trial 38826 (Study 38827)(P06056)(COMPLETED)

Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established During Clinical Trial 38826 for the Development of Org 36286 (Corifollitropin Alfa).

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 44 (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 for the induction of multifollicular growth in women undergoing controlled ovarian stimulation (COS) for in vitro fertilization (IVF) or intracytoplasmatic sperm injection (ICSI) is safe for pregnant subjects and their offspring.

Detailed description

This was an open, prospective follow-up trial to monitor pregnancy, delivery, and neonatal outcome of women who became pregnant during Trial 38826. For this trial, no study specific assessments were required, but information obtained in standard practice was used.

Conditions

• Pregnancy
• Neonates

Interventions

Type	Name	Description
DRUG	Org 36286	single dose of 60, 120, or 180 μg Org 36286 (experimental group administered under protocol 38826)
DRUG	recFSH	150 IU recFSH daily (reference group administered under protocol 38826)

Timeline

• Start date: 2003-10-01
• Primary completion: 2005-02-28
• Completion: 2005-02-28
• First posted: 2008-06-20
• Last updated: 2022-02-03