Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
In this study the effectiveness of degarelix, a long acting GnRH antagonist administered in a unique administration of 20 mg the first day of menstrual cycle, to prevent ovarian hyperstimulation syndrome (OHSS) in PCOS women at risk to develop OHSS.
Women with PCOS are at risk to develop OHSS when stimulated with gonadotrophins for IVF. For this reason in this study the degarelix was tested in order to minimize the risk of OHSS as well as to improve the pregnancy rate in these patients. The use of long acting GnRH antagonist promotes a deep suppression of LH and consequently the activity of theca cells, which secrete androgens (the precursors of estradiol), and consequently the levels of estradiol remains low. Comparing the long acting GnRH antagonist at the first day of cycle with a flexible GnRH antagonist protocol in a group of patients with PCOS will be useful in order to establish the best way to perform controlled hyperstimulation in IVF cycles and minimize the risk of OHSS.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| degarelix group | Experimental | group of patients treated with long acting GnRH antagonist |
|
| Cetrorelix 0.25mg | Active Comparator | patients treated with gonadotropin and Cetrorelix ina flexible GnRH antagonist protocol |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| degarelix (long acting GnRH antagonist) | Drug | 20 mg of degarelix the first day of menstrual cycle before starting with gonadotrophins administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| PREGNANCY RATE | number of ongoing pregnancy obtained in the group | 6 MONTHS |
| ovarian hyperstimulation syndrome rate | incidence of ovarian hyperstimulation syndrome in the groups | 6 MONTHS |
| Measure | Description | Time Frame |
|---|---|---|
| implantation rate | number of implanted embryos divided for the number of transferred embryos | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| number of mature oocytes | number of mature oocytes obtained in each patient | 6 months |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Marco Sbracia, MD | Centre for Endocrinology and Reproductive Medicine, Italy | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cerm-Hungaria | Rome | 00153 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22197127 | Result | Garcia-Velasco JA, Kupesic S, Pellicer A, Bourgain C, Simon C, Mrazek M, Devroey P, Arce JC. Follicular and endocrine profiles associated with different GnRH-antagonist regimens: a randomized controlled trial. Reprod Biomed Online. 2012 Feb;24(2):153-62. doi: 10.1016/j.rbmo.2011.10.016. Epub 2011 Nov 4. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| cetrorelix 0.25mg | Drug | 0.25mg of cetrorelix during treatment with gonadotrophins when estradiol levels were >300pg/ml |
|
|
| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C431566 | acetyl-2-naphthylalanyl-3-chlorophenylalanyl-1-oxohexadecyl-seryl-4-aminophenylalanyl(hydroorotyl)-4-aminophenylalanyl(carbamoyl)-leucyl-ILys-prolyl-alaninamide |
| C062876 | cetrorelix |
Not provided
Not provided
Not provided