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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.
trial testing ganirelix in Pregnancy in 2,066 participants. Completed in 1 November 2005.
1 November 2005
Quick facts
| Lead sponsor | Organon and Co |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 2,066 |
| Start date | 1 November 2000 |
| Primary completion | 1 November 2005 |
| Estimated completion | 1 November 2005 |
Drugs / interventions tested
- ganirelix (GANIRELIX) — full drug profile →
- GnRH agonist — full drug profile →
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.
-
To collect data on the incidence of congenital malformations in infants of women with an ongoing pregnancy after controlled ovarian hyperstimulation.
Time frame: In both cohorts a follow-up pediatric evaluation was scheduled within 6 months post-partum
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:
- PubMed search for NCT00724789
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Organon and Co trials
Trials by the same sponsor.
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- NCT05560646 — A Study to Investigate Efficacy and Safety of OG-6219 BID in 3 Dose Levels Compared With Placebo in Participants Aged 18 · Phase 2 · completed
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00724789 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Organon and Co
- Last refreshed: 1 February 2022
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