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Cetrorelix and Ganirelix Flexible Protocol for (IVF)

NCT03477929 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2018-03-27

No results posted yet for this study

Summary

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).

Conditions

  • Infertility/Sterility

Interventions

DRUG

Ganirelix Acetate

multiple dose of Ganirelix acetate (0.25mg) are administered when the lead follicle is ≥ 14 mm until hCG criteria are met

DRUG

Cetrorelix Acetate

multiple dose of Cetrorelix acetate (0.25mg) are administered when the lead follicle is ≥ 14 mm until hCG criteria are met

Sponsors & Collaborators

  • Università degli Studi 'G. d'Annunzio' Chieti e Pescara

    lead OTHER

Principal Investigators

  • Gian Mario Tiboni, professor · Università degli Studi 'G. d'Annunzio' Chieti e Pescara

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
39 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-11-15
Primary Completion
2018-12-15
Completion
2019-01-15

Countries

  • Italy

Study Locations

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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 NCT03477929 on ClinicalTrials.gov