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NCT03477929: IVF

Cetrorelix and Ganirelix Flexible Protocol for (IVF)

Status unknown Phase 4 Last updated 27 March 2018
What this trial tests

Phase 4 trial testing Ganirelix Acetate in Infertility/Sterility in 100 participants. Status unknown.

Timeline
15 November 2017
Primary endpoint
15 December 2018
15 January 2019

Quick facts

Lead sponsorUniversità degli Studi 'G. d'Annunzio' Chieti e Pescara
PhasePhase 4
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment100
Start date15 November 2017
Primary completion15 December 2018
Estimated completion15 January 2019
Sites1 location across Italy

Drugs / interventions tested

Conditions studied

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.

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Data sources for this page

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