Cetrorelix and Ganirelix Flexible Protocol for (IVF)

NCT03477929 | Unknown Phase 4

• 1 other identifier: Cetrorelix-Ganirelix
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

In vitro fertilization; gnrh antagonist; pituitary suppression

Outcome Measures

Primary Outcomes (1)

• serum LH levels

  percentage of patients not having serum levels of LH ≥ 10IU\\L (defined as premature LH surge) on the day of hCG administration.

  through study completion,an average of 9 months

Secondary Outcomes (17)

• number of follicles ≥ 14mm on the day of hCG administration

  through study completion,an average of 9 months

• FSH serum levels on the day of hCG administration

  through study completion,an average of 9 months

• FSH on the day of antagonist administration

  through study completion,an average of 9 months

• FSH serum level on the day after the antagonist administration

  through study completion,an average of 9 months

• LH serum level on the day of antagonist administration

  through study completion,an average of 9 months

Study Arms (2)

ganirelix

EXPERIMENTAL

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

Drug: Ganirelix Acetate

cetrorelix

EXPERIMENTAL

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

Drug: Cetrorelix Acetate

Interventions

Ganirelix Acetate DRUG

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

ganirelix

Cetrorelix Acetate DRUG

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

cetrorelix

Eligibility Criteria

• Age: 18 Years - 39 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• hyears old with regular menstrual cycles (25-35 days in length);
• Body Mass Index between 18-29 kg\\m2
• Basal follicle-stimulating hormone levels within normal range (\<30 mUI\\mL)
• Absence of clinically relevant anomalies at transvaginal ultrasound examinatio

You may not qualify if:

• Patients affected by grade III or IV endometriosis according to American Society for Reproductive Medicine (ASRM)
• History of Ovarian Hyperstimulation Stimulation (OHSS)
• History of poor response in previous IVF\\ICSI cycle: ≤ 3 oocytes retrieved
• ≥ 3 prior consecutive IVF\\ICSI cycle without a clinical pregnancy.

Sponsors & Collaborators

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

Study Sites (1)

Ospedale Bernabeo

Ortona, Chieti, 66026, Italy

RECRUITING

MeSH Terms

Conditions

Infertility

Interventions

ganirelix; cetrorelix

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Gian Mario Tiboni, professor

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

  STUDY DIRECTOR

Central Study Contacts

Gian Mario Tiboni, professor

CONTACT

347 8787545; tiboni@unich.it

Antonia Iacovelli, doctor

CONTACT

3203595229; antonia.iacovelli.med@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 28, 2018
• First Posted: March 27, 2018
• Study Start: November 15, 2017
• Primary Completion: December 15, 2018
• Study Completion: January 15, 2019
• Last Updated: March 27, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)