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NCT03477929: IVF
Cetrorelix and Ganirelix Flexible Protocol for (IVF)
Phase 4 trial testing Ganirelix Acetate in Infertility/Sterility in 100 participants. Status unknown.
15 December 2018
Quick facts
| Lead sponsor | Università degli Studi 'G. d'Annunzio' Chieti e Pescara |
|---|---|
| Phase | Phase 4 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 100 |
| Start date | 15 November 2017 |
| Primary completion | 15 December 2018 |
| Estimated completion | 15 January 2019 |
| Sites | 1 location across Italy |
Drugs / interventions tested
- Ganirelix Acetate (GANIRELIX) — full drug profile →
- Cetrorelix Acetate — full drug profile →
Conditions studied
- Infertility/Sterility — all drugs for Infertility/Sterility →
Sponsor
Università degli Studi 'G. d'Annunzio' Chieti e Pescara
Who can join
Adults 18 to 39, female only, with Infertility/Sterility. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Recombinant gonadotropins are currently used for ovarian stimulation in women undergoing to IVF for infertility. Recently new flexible protocols have been introduced: the "single dose" and "multiple dose" protocol. The single dose protocol is performed just using Cetrorelix by the administration of a single injection of Cetrorelix 3 mg subcutaneous when the lead follicle is ≥ 14 mm. The multiple dose protocol consider the daily administration of Cetrorelix 0.25 mg subcutaneous or Ganirelix 0.25 mg subcutaneous when the lead follicle is ≥ 14 mm and until the realization of hCG criteriaThere are few data from letterature about the comparison of the efficacy in pitituary suppression and pregnancy outcome of Ganirelix and Cetrorelix. Objective: to compare the efficacy in pituitary gonadotropin suppression and IVF outcome of multiple dose flexible gonadotrophin-releasing hormone (GnRH) antagonist administration according to follicular size using daily injection of Cetrorelix or Ganirelix. Interventions : patients are randomly assigned in to Cetrorelix acetate group or Ganirelix acetate group. Multiple dose of Cetrorelix acetate (0.25 mg) or multiple dose of Ganirelix acetate (0.25mg) are administered when the lead follicle is ≥ 14 mm until hCG criteria are met.Oocyte maturation trigger is performed by the administration of subcutaneous r-hCG (250 μg) or of intramuscular hCG (10,000 IU). After 36 hour transvaginal oocyte retrieval is performed followed by ICSI and embrio transfer (72 hours later).
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT03477929
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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 NCT03477929 (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 Università degli Studi 'G. d'Annunzio' Chieti e Pescara
- Last refreshed: 27 March 2018
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/NCT03477929.
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