Clinical trial NCT03477929: Cetrorelix and Ganirelix Flexible Protocol for (IVF)
Official title: Cetrorelix and Ganirelix Flexible Protocol for In Vitro Fertilization: a Prospective Randomized Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Infertility/Sterility
Keywords: In vitro fertilization
gnrh antagonist
pituitary suppression
Lead sponsor: Università degli Studi 'G. d'Annunzio' Chieti e Pescara
Sponsor class: OTHER
First posted: 2018-03-27
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility 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.

Primary outcomes:
measure: serum LH levels
timeFrame: through study completion,an average of 9 months
Secondary outcomes:
measure: number of follicles ≥ 14mm on the day of hCG administration
timeFrame: through study completion,an average of 9 months
measure: FSH serum levels on the day of hCG administration
timeFrame: through study completion,an average of 9 months
measure: FSH on the day of antagonist administration
timeFrame: through study completion,an average of 9 months
measure: FSH serum level on the day after the antagonist administration
timeFrame: through study completion,an average of 9 months
measure: LH serum level on the day of antagonist administration
timeFrame: through study completion,an average of 9 months
measure: LH serum level on the day after the antagonist administration
timeFrame: through study completion,an average of 9 months
measure: E2 serum level on the day of antagonist administration
timeFrame: through study completion,an average of 9 months
measure: E2 serum level on the day after the antagonist administration
timeFrame: through study completion,an average of 9 months
measure: number of oocyte retrieved
timeFrame: through study completion,an average of 9 months
measure: number of metaphase II oocyte retrieved
timeFrame: through study completion,an average of 9 months
measure: embryos obtained for patients
timeFrame: 72 hours after transvaginal oocyte retrieval
measure: grade A embryos transferred
timeFrame: 72 hours after transvaginal oocyte retrieval
measure: total dose of gonadotropins administered
timeFrame: through study completion,an average of 9 months
measure: duration of gonadotropin treatment
timeFrame: through study completion,an average of 9 months
measure: percentage of patients developing OHSS
timeFrame: 15 days after the transvaginal oocyte retrieval
measure: implantation rate
timeFrame: 30 days after the embyo transfer
measure: pregnancy rate
timeFrame: 14 days after the transvaginal oocyte retrieval
Other outcomes:
Locations:
city: Ortona
country: Italy
facility: Ospedale Bernabeo
state: Chieti
Study officials:
affiliation: Università degli Studi 'G. d'Annunzio' Chieti e Pescara
name: Gian Mario Tiboni, professor
role: STUDY_DIRECTOR
References: