Cetrorelix and Ganirelix Flexible Protocol for (IVF)
- Registration Number
- NCT03477929
- Lead Sponsor
- Università degli Studi 'G. d'Annunzio' Chieti e Pescara
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 100
Not provided
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ganirelix Ganirelix Acetate multiple dose of Ganirelix acetate (0.25mg) are administered when the lead follicle is ≥ 14 mm until hCG criteria are met cetrorelix Cetrorelix Acetate multiple dose of Cetrorelix acetate (0.25mg) are administered when the lead follicle is ≥ 14 mm until hCG criteria are met
- Primary Outcome Measures
Name Time Method serum LH levels 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 Outcome Measures
Name Time Method FSH serum levels on the day of hCG administration through study completion,an average of 9 months mUI/ml
FSH on the day of antagonist administration through study completion,an average of 9 months mUI/ml
FSH serum level on the day after the antagonist administration through study completion,an average of 9 months mUI/ml
grade A embryos transferred 72 hours after transvaginal oocyte retrieval number of grade A embryo were transferred for patient
implantation rate 30 days after the embyo transfer The number of gestational sacs observed divided by the number of embryos transferred.
embryos obtained for patients 72 hours after transvaginal oocyte retrieval how many embryos were obtained for patient for each arm
LH serum level on the day of antagonist administration through study completion,an average of 9 months mUI/ml
E2 serum level on the day of antagonist administration through study completion,an average of 9 months mUI/ml
percentage of patients developing OHSS 15 days after the transvaginal oocyte retrieval how many patient for each arm develop OHSS (Ovarian Hyperstimulation Syndrome)
E2 serum level on the day after the antagonist administration through study completion,an average of 9 months mUI/ml
number of follicles ≥ 14mm on the day of hCG administration through study completion,an average of 9 months number of follicles ≥ 14mm
LH serum level on the day after the antagonist administration through study completion,an average of 9 months mUI/ml
number of oocyte retrieved through study completion,an average of 9 months how many oocyte were retrieved on transvaginal oocyte retrieval
number of metaphase II oocyte retrieved through study completion,an average of 9 months how many metaphase II oocyte were retrieved on transvaginal oocyte retrieval
total dose of gonadotropins administered through study completion,an average of 9 months number of Units of gonadotropin administered for Controlled Ovarian Hyperstimulation
duration of gonadotropin treatment through study completion,an average of 9 months how many days were necessary to complete the Controlled Ovarian Hyperstimulation
pregnancy rate 14 days after the transvaginal oocyte retrieval The number of clinical pregnancy (Positive hCG test) divided by the number of embryos transferred
Trial Locations
- Locations (1)
Ospedale Bernabeo
🇮🇹Ortona, Chieti, Italy