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

Completed

• Conditions: Pregnancy; Neonates
• Interventions: Drug: GnRH agonist; Drug: ganirelix

• Registration Number: NCT00724789
• Lead Sponsor: Organon and Co

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2000-11
• Primary Completion: 2005-11
• Study Completion: 2005-11
• Study First Submitted: 2008-07-28
• Study First Submitted QC: 2008-07-28
• Study First Posted: 2008-07-30
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-01
• Last Update Posted: 2022-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 2066

Inclusion Criteria

• Puregon® (recFSH)/Orgalutran® group:

  • Women with a pregnancy of >= 16 weeks after Puregon® /Orgalutran® treatment for IVF or ICSI and ET of fresh embryos. Treatment is defined as having had at least one injection of Orgalutran®.
  • Women between 18 and 39 years of age (inclusive) at the day of hCG.
  • Women who are able and willing to sign informed consent.

Controls

• Infants (gestational age >=16 weeks) of women pregnant after COH using a GnRH agonist in a long protocol for IVF or ICSI and ET of fresh embryos.
• Infants of women between 18 and 39 years of age (inclusive) at the day of hCG.
• The most recent 1000 infants delivered prior to January 1, 2001.

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Historical Controls	GnRH agonist	Subjects with an ongoing pregnancy after controlled ovarian stimulations with recombinant follicle stimulating hormone in a long protocol with a gonadotropin releasing hormone agonist followed by IVF or ICSI
Observational Cohort	ganirelix	Subjects with an ongoing pregnancy after controlled ovarian stimulations with recombinant follicle stimulating hormone/ganirelix followed by in vitro fertilization or intra cytoplasmatic sperm injection.

Primary Outcome Measures

Name	Time	Method
To collect data on the incidence of congenital malformations in infants of women with an ongoing pregnancy after controlled ovarian hyperstimulation.	In both cohorts a follow-up pediatric evaluation was scheduled within 6 months post-partum