Long Acting GnRH Antagonist in PCOS Women Undergoing IVF

Study Overview
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Brief Summary
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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.

Official Title
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The Use of a Long Acting GnRH Antagonist (Degarelix) in Controlled Ovarian Hyperstimulation in PCOS Women at a Risk to Developing OHSS Undergoing IVF : a Pilot Study

Conditions
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Polycystic Ovarian Syndrome, Ovarian Hyperstimulation Syndrome, Invitro Fertilization

Intervention / Treatment
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* Drug: GnRH antagonist depot Degarelix


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: regular menstrual cycle (26-39 days) primary infertility BMI < 30 Exclusion Criteria: women with diabetes and other metabolic disease women with heart disease women with inflammatory or autoimmune disease

Ages Eligible for Study
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Minimum Age: 23 Years
Maximum Age: 37 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| GnRH antagonist depot, Degarelix<br>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 | Drug: GnRH antagonist depot Degarelix<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pregnancy rate |  | Time Frame: until 12th gestational week | 
| Incidence of OHSS |  | Time frame: until 7th gestational week | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | Time frame: until 12th gestational week | 
| Total days of stimulation |  | Time frame: until 12th gestational week | 
| implantation rate |  | time frame: until 12th gestational week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IVF, PCOS, OHSS, GnRH antagonist, COH