NCT00724789

Monitor the Incidence of Congenital Malformations in Infants of Women Who Have Been Treated With Ganirelix (Orgalutran®)(Study 38644)(P05966)(COMPLETED)

An Open-label, Observational Trial to Monitor the Incidence of Congenital Malformations in Infants of Women With an Ongoing Pregnancy After Controlled Ovarian Hyperstimulation Using Puregon® (recFSH)/Orgalutran® (Ganirelix) Followed by IVF/ICSI, or a Long Protocol With a GnRH Agonist as Historical Controls.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 2,066 (actual)
• Sponsor: Organon and Co · Industry
• Sex: Female
• Age: 18 Years – 39 Years
• Healthy volunteers: Not accepted

Summary

The primary purpose of this study is to collect data on the incidence of congenital malformations in infants of women with an ongoing pregnancy after controlled ovarian stimulation with recombinant follicle stimulating hormone /ganirelix followed by in vitro fertilization (IVF) or intra cytoplasmatic sperm injection (ICSI), and to compare this incidence with that of a group of women who used a long protocol with a gonadotropin releasing hormone agonist as historical controls.

Conditions

• Pregnancy
• Neonates

Interventions

Type	Name	Description
DRUG	ganirelix	Daily 0.25 mg ganirelix administered to prevent premature LH surges during COS in order to achieve a pregnancy
DRUG	GnRH agonist	Long protocol of GnRH agonist administered to prevent premature LH surges during COS in order to achieve a pregnancy

Timeline

• Start date: 2000-11-01
• Primary completion: 2005-11-01
• Completion: 2005-11-01
• First posted: 2008-07-30
• Last updated: 2022-02-03