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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
multiple dose of Ganirelix acetate (0.25mg) are administered when the lead follicle is ≥ 14 mm until hCG criteria are met
multiple dose of Cetrorelix acetate (0.25mg) are administered when the lead follicle is ≥ 14 mm until hCG criteria are met
Ospedale Bernabeo
Ortona, Chieti, Italy
RECRUITINGserum LH levels
percentage of patients not having serum levels of LH ≥ 10IU\\L (defined as premature LH surge) on the day of hCG administration.
Time frame: through study completion,an average of 9 months
number of follicles ≥ 14mm on the day of hCG administration
number of follicles ≥ 14mm
Time frame: through study completion,an average of 9 months
FSH serum levels on the day of hCG administration
mUI/ml
Time frame: through study completion,an average of 9 months
FSH on the day of antagonist administration
mUI/ml
Time frame: through study completion,an average of 9 months
FSH serum level on the day after the antagonist administration
mUI/ml
Time frame: through study completion,an average of 9 months
LH serum level on the day of antagonist administration
mUI/ml
Time frame: through study completion,an average of 9 months
LH serum level on the day after the antagonist administration
mUI/ml
Time frame: through study completion,an average of 9 months
E2 serum level on the day of antagonist administration
mUI/ml
Time frame: through study completion,an average of 9 months
E2 serum level on the day after the antagonist administration
mUI/ml
Time frame: through study completion,an average of 9 months
number of oocyte retrieved
how many oocyte were retrieved on transvaginal oocyte retrieval
Time frame: through study completion,an average of 9 months
number of metaphase II oocyte retrieved
how many metaphase II oocyte were retrieved on transvaginal oocyte retrieval
Time frame: through study completion,an average of 9 months
embryos obtained for patients
how many embryos were obtained for patient for each arm
Time frame: 72 hours after transvaginal oocyte retrieval
grade A embryos transferred
number of grade A embryo were transferred for patient
Time frame: 72 hours after transvaginal oocyte retrieval
total dose of gonadotropins administered
number of Units of gonadotropin administered for Controlled Ovarian Hyperstimulation
Time frame: through study completion,an average of 9 months
duration of gonadotropin treatment
how many days were necessary to complete the Controlled Ovarian Hyperstimulation
Time frame: through study completion,an average of 9 months
percentage of patients developing OHSS
how many patient for each arm develop OHSS (Ovarian Hyperstimulation Syndrome)
Time frame: 15 days after the transvaginal oocyte retrieval
implantation rate
The number of gestational sacs observed divided by the number of embryos transferred.
Time frame: 30 days after the embyo transfer
pregnancy rate
The number of clinical pregnancy (Positive hCG test) divided by the number of embryos transferred
Time frame: 14 days after the transvaginal oocyte retrieval
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