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PCOS is a common endocrinopathy affecting 5-10% of women in their reproductive age characterized by hyperandrogenism, chronic anovulation and polycystic ovaries. This syndrome is a serious problem in IVF since there is a high risk of developing ovarian hyperstimulation syndrome (OHSS) during ovarian stimulation with gonadotropins. The introduction of GnRH antagonist in IVF has reduced the incidence of severe OHSS, still maintaining a good ovarian response and pregnancy rate. Recently, a long acting GnRH antagonist, Degarelix, was introduced for prostatic cancer treatment. Furthermore a recent paper reported its use also for the induction of multiple follicular growth in a program of oocyte donation. The aim of this study is to evaluate the feasibility of GnRH antagonist depot use in a protocol of controlled ovarian hyperstimulation in PCOS women at risk of developing OHSS in IVF cycles.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GnRH antagonist depot, Degarelix | Women receive 20 mg of Degarelix on the first day of menstrual cycle followed by a fixed dose of 225 IU of recombinant FSH on the second day until the day of ovulation triggering |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GnRH antagonist depot Degarelix | Drug | Women receive 20 mg of Degarelix on the first day of menstrual cycle followed by a fixed dose of 225 IU of recombinant FSH on the second day until the day of ovulation triggering |
| Measure | Description | Time Frame |
|---|---|---|
| Pregnancy rate | Time Frame: until 12th gestational week | |
| Incidence of OHSS | Time frame: until 7th gestational week |
| Measure | Description | Time Frame |
|---|---|---|
| Number of collected oocytes | Time Frame: until 12th gestational week | |
| Estradiol level at HCG day | time frame: until 12th gestational week | |
| Total dose of FSH administered |
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Inclusion Criteria:
Exclusion Criteria:
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Women with PCOS with a previous IVF attempt cancelled due to the risk of OHSS
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mauro Schimberni, MD | Contact | +39063334266 | bioroma@bioroma.net |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bioroma | Recruiting | Rome | Italy | 00197 | Italy |
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| ID | Term |
|---|---|
| D011085 | Polycystic Ovary Syndrome |
| D016471 | Ovarian Hyperstimulation Syndrome |
| ID | Term |
|---|---|
| D010048 | Ovarian Cysts |
| D003560 | Cysts |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 |
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| Time frame: until 12th gestational week |
| Total days of stimulation | Time frame: until 12th gestational week |
| implantation rate | time frame: until 12th gestational week |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |