Infertility/Sterility
Conditions
Keywords
In vitro fertilization, gnrh antagonist, pituitary suppression
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).
Interventions
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
Sponsors
Università degli Studi 'G. d'Annunzio' Chieti e Pescara
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 39 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| LH serum level on the day of antagonist administration | through study completion,an average of 9 months | mUI/ml |
| LH serum level on the day after the 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 |
| E2 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 follicles ≥ 14mm on the day of hCG administration | through study completion,an average of 9 months | number of follicles ≥ 14mm |
| embryos obtained for patients | 72 hours after transvaginal oocyte retrieval | how many embryos were obtained for patient for each arm |
| grade A embryos transferred | 72 hours after transvaginal oocyte retrieval | number of grade A embryo were transferred for patient |
| 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 |
| percentage of patients developing OHSS | 15 days after the transvaginal oocyte retrieval | how many patient for each arm develop OHSS (Ovarian Hyperstimulation Syndrome) |
| implantation rate | 30 days after the embyo transfer | The number of gestational sacs observed divided by the number of embryos transferred. |
| pregnancy rate | 14 days after the transvaginal oocyte retrieval | The number of clinical pregnancy (Positive hCG test) divided by the number of embryos transferred |
| 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 |
Countries
Italy
Contacts
Primary ContactGian Mario Tiboni, professor
Backup ContactAntonia Iacovelli, doctor
Outcome results
None listed