Cetrorelix and Ganirelix Flexible Protocol for In Vitro Fertilization: a Prospective Randomized Trial
Trial Snapshot
- Phase
- Phase 4
- Sponsor
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- serum LH levels
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 39 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Not provided
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.
Arms & Interventions
ganirelix
multiple dose of Ganirelix acetate (0.25mg) are administered when the lead follicle is ≥ 14 mm until hCG criteria are met
Intervention: Ganirelix Acetate (Drug)
cetrorelix
multiple dose of Cetrorelix acetate (0.25mg) are administered when the lead follicle is ≥ 14 mm until hCG criteria are met
Intervention: Cetrorelix Acetate (Drug)
Outcomes
Primary Outcomes
serum LH levels
Time Frame: through study completion,an average of 9 months
percentage of patients not having serum levels of LH ≥ 10IU\\L (defined as premature LH surge) on the day of hCG administration.
Secondary Outcomes
- 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)
- grade A embryos transferred(72 hours after transvaginal oocyte retrieval)
- implantation rate(30 days after the embyo transfer)
- LH serum level on the day of antagonist administration(through study completion,an average of 9 months)
- E2 serum level on the day of antagonist administration(through study completion,an average of 9 months)
- percentage of patients developing OHSS(15 days after the transvaginal oocyte retrieval)
- number of follicles ≥ 14mm on the day of hCG administration(through study completion,an average of 9 months)
- LH serum level on the day after the antagonist administration(through study completion,an average of 9 months)
- number of oocyte retrieved(through study completion,an average of 9 months)
- number of metaphase II oocyte retrieved(through study completion,an average of 9 months)
- E2 serum level on the day after the antagonist administration(through study completion,an average of 9 months)
- embryos obtained for patients(72 hours after transvaginal oocyte retrieval)
- total dose of gonadotropins administered(through study completion,an average of 9 months)
- duration of gonadotropin treatment(through study completion,an average of 9 months)
- pregnancy rate(14 days after the transvaginal oocyte retrieval)
Investigators
Antonia Iacovelli
Principal Investigator
Università degli Studi 'G. d'Annunzio' Chieti e Pescara