Cetrorelix and Ganirelix Flexible Protocol for (IVF)

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

Status and phase: Unknown; Phase 4

Conditions: Infertility/Sterility

Treatments: Drug: Cetrorelix Acetate; Drug: Ganirelix Acetate

Study type: Interventional

Funder types: Other

Identifiers

NCT03477929

Cetrorelix-Ganirelix

Details and patient eligibility

About

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).

Enrollment: 100 estimated patients

Sex: Female

Ages: 18 to 39 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria :

• 18-39 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

Exclusion Criteria:

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

ganirelix

Experimental group

Description:

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

Treatment:

Drug: Ganirelix Acetate

cetrorelix

Experimental group

Description:

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

Treatment:

Drug: Cetrorelix Acetate