NCT00702624

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

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)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 113 (actual)
• Sponsor: Organon and Co · Industry
• Sex: Female
• Age: 18 Years – 36 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Pregnancy
• Neonates

Interventions

Type	Name	Description
DRUG	Corifollitropin alfa	Single injection of 100 μg corifollitropin alfa administered under protocol P05690
BIOLOGICAL	recFSH (follitropin beta)	Daily recFSH administered under protocol P05690
DRUG	gonadatropin releasing hormone (GnRH) antagonist ganirelix	GnRH antagonist ganirelix administered SC at a dose of 0.25 mg/day under protocol P05690
BIOLOGICAL	human chorion gonadotropin (hCG)	hCG 5,000 IU/USP or 10,000 IU/USP administered under protocol P05690
BIOLOGICAL	progesterone	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.
DRUG	placebo-recFSH (follitropin beta)	Placebo-recFSH at the equivalent volume of 150 IU/day administered under protocol P05690
DRUG	placebo-corifollitropin alfa	Single SC injection of placebo-corifollitropin alfa on Day 2 or 3 of the menstrual cycle, administered under protocol P05690
BIOLOGICAL	open-label recFSH (follitropin beta)	Open-label recFSH up to a maximum dose of 200 IU/day, administered under protocol P05690

Timeline

• Start date: 2007-04-01
• Primary completion: 2008-04-01
• Completion: 2008-06-01
• First posted: 2008-06-20
• Last updated: 2022-02-03
• Results posted: 2015-04-30