Use of Degarelix in Controlled Ovarian Hyperstimulation (COH) Protocol for Women With PoliCystic Ovarian Syndrome (PCOS)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Use of Long Acting GnRH Antagonist to Prevent Ovarian HyperStimulation Syndrome (OHSS) in PCOS Women Undergoing COH for IVF

Conditions
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PCOS, OHSS, INFERTILITY

Intervention / Treatment
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* Drug: degarelix (long acting GnRH antagonist)
* Drug: cetrorelix 0.25mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: women with PCOS previous OHSS Infertility Exclusion Criteria: more than 38 years old Body mass index pore than 30 other systemic diseases

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 38 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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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: degarelix group<br>group of patients treated with long acting GnRH antagonist | Drug: degarelix (long acting GnRH antagonist)<br>* 20 mg of degarelix the first day of menstrual cycle before starting with gonadotrophins administration<br>* Other names: Firmagon;|
| Active Comparator: Cetrorelix 0.25mg<br>patients treated with gonadotropin and Cetrorelix ina flexible GnRH antagonist protocol | Drug: cetrorelix 0.25mg<br>* 0.25mg of cetrorelix during treatment with gonadotrophins when estradiol levels were >300pg/ml<br>* Other names: cetrotide;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| implantation rate | number of implanted embryos divided for the number of transferred embryos | 6 months | 

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