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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ganirelix | Experimental | multiple dose of Ganirelix acetate (0.25mg) are administered when the lead follicle is ≥ 14 mm until hCG criteria are met |
|
| cetrorelix | Experimental | multiple dose of Cetrorelix acetate (0.25mg) are administered when the lead follicle is ≥ 14 mm until hCG criteria are met |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ganirelix Acetate | Drug | multiple dose of Ganirelix acetate (0.25mg) are administered when the lead follicle is ≥ 14 mm until hCG criteria are met |
|
| Measure | Description | Time Frame |
|---|---|---|
| serum LH levels | percentage of patients not having serum levels of LH ≥ 10IU\L (defined as premature LH surge) on the day of hCG administration. | through study completion,an average of 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| number of follicles ≥ 14mm on the day of hCG administration | number of follicles ≥ 14mm | through study completion,an average of 9 months |
| FSH serum levels on the day of hCG administration | mUI/ml |
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Inclusion criteria :
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gian Mario Tiboni, professor | Contact | 347 8787545 | tiboni@unich.it | |
| Antonia Iacovelli, doctor | Contact | 3203595229 | antonia.iacovelli.med@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Gian Mario Tiboni, professor | Università degli Studi 'G. d'Annunzio' Chieti e Pescara | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ospedale Bernabeo | Recruiting | Ortona | Chieti | 66026 | Italy |
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| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| C061018 | ganirelix |
| C062876 | cetrorelix |
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| Cetrorelix Acetate | Drug | multiple dose of Cetrorelix acetate (0.25mg) are administered when the lead follicle is ≥ 14 mm until hCG criteria are met |
|
| through study completion,an average of 9 months |
| FSH on the day of antagonist administration | mUI/ml | through study completion,an average of 9 months |
| FSH serum level on the day after the antagonist administration | mUI/ml | through study completion,an average of 9 months |
| LH serum level on the day of antagonist administration | mUI/ml | through study completion,an average of 9 months |
| LH serum level on the day after the antagonist administration | mUI/ml | through study completion,an average of 9 months |
| E2 serum level on the day of antagonist administration | mUI/ml | through study completion,an average of 9 months |
| E2 serum level on the day after the antagonist administration | mUI/ml | through study completion,an average of 9 months |
| number of oocyte retrieved | how many oocyte were retrieved on transvaginal oocyte retrieval | 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 | through study completion,an average of 9 months |
| embryos obtained for patients | how many embryos were obtained for patient for each arm | 72 hours after transvaginal oocyte retrieval |
| grade A embryos transferred | number of grade A embryo were transferred for patient | 72 hours after transvaginal oocyte retrieval |
| total dose of gonadotropins administered | number of Units of gonadotropin administered for Controlled Ovarian Hyperstimulation | through study completion,an average of 9 months |
| duration of gonadotropin treatment | how many days were necessary to complete the Controlled Ovarian Hyperstimulation | through study completion,an average of 9 months |
| percentage of patients developing OHSS | how many patient for each arm develop OHSS (Ovarian Hyperstimulation Syndrome) | 15 days after the transvaginal oocyte retrieval |
| implantation rate | The number of gestational sacs observed divided by the number of embryos transferred. | 30 days after the embyo transfer |
| pregnancy rate | The number of clinical pregnancy (Positive hCG test) divided by the number of embryos transferred | 14 days after the transvaginal oocyte retrieval |