DRUG
Ganirelix Acetate
multiple dose of Ganirelix acetate (0.25mg) are administered when the lead follicle is ≥ 14 mm until hCG criteria are met
Status
Unknown
Phase
Phase 4
Enrollment
100
Locations
1
Results
Not posted
Publications
0
Study 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).
Interventions
DRUG
multiple dose of Ganirelix acetate (0.25mg) are administered when the lead follicle is ≥ 14 mm until hCG criteria are met
DRUG
multiple dose of Cetrorelix acetate (0.25mg) are administered when the lead follicle is ≥ 14 mm until hCG criteria are met
Timeline
First posted
Mar 27, 2018
Study start
Nov 15, 2017
Primary completion
Dec 15, 2018
Study completion
Jan 15, 2019
Results posted
Not reported
Registry updated
Mar 27, 2018
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.
number of follicles ≥ 14mm on the day of hCG administration
Time frame · through study completion,an average of 9 months
number of follicles ≥ 14mm
FSH serum levels on the day of hCG administration
Time frame · through study completion,an average of 9 months
mUI/ml
FSH on the day of antagonist administration
Time frame · through study completion,an average of 9 months
mUI/ml
FSH serum level on the day after the antagonist administration
Time frame · through study completion,an average of 9 months
mUI/ml
LH serum level on the day of antagonist administration
Time frame · through study completion,an average of 9 months
mUI/ml
LH serum level on the day after the antagonist administration
Time frame · through study completion,an average of 9 months
mUI/ml
E2 serum level on the day of antagonist administration
Time frame · through study completion,an average of 9 months
mUI/ml
E2 serum level on the day after the antagonist administration
Time frame · through study completion,an average of 9 months
mUI/ml
number of oocyte retrieved
Time frame · through study completion,an average of 9 months
how many oocyte were retrieved on transvaginal oocyte retrieval
number of metaphase II oocyte retrieved
Time frame · through study completion,an average of 9 months
how many metaphase II oocyte were retrieved on transvaginal oocyte retrieval
Eligibility
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.
Study locations
Italy. Showing up to 24 locations stored in the fast local snapshot.
Ospedale Bernabeo
Ortona, Chieti, Italy
Publications
No PMID-linked publications were present in this registry snapshot.
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