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NCT00724789

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.

Completed Last updated 1 February 2022
What this trial tests

trial testing ganirelix in Pregnancy in 2,066 participants. Completed in 1 November 2005.

Timeline
1 November 2000
Primary endpoint
1 November 2005
1 November 2005

Quick facts

Lead sponsorOrganon and Co
StatusCompleted
Study typeOBSERVATIONAL
Enrollment2,066
Start date1 November 2000
Primary completion1 November 2005
Estimated completion1 November 2005

Drugs / interventions tested

Conditions studied

Sponsor

Organon and Co — full company profile →

Who can join

Adults 18 to 39, female only, with Pregnancy or Neonates. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Pregnancy

Currently open trials in the same condition.

Other Organon and Co trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00724789.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing