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

NCT00724789 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 2066

Last updated 2022-02-03

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Organon and Co

    lead INDUSTRY

Eligibility

Min Age
18 Years
Max Age
39 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2000-11-30
Primary Completion
2005-11-30
Completion
2005-11-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00724789 on ClinicalTrials.gov