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

Phase 3

Completed

• Conditions: OHSS; PCOS; INFERTILITY
• Interventions: Drug: cetrorelix 0.25mg; Drug: degarelix (long acting GnRH antagonist)

• Registration Number: NCT01709942
• Lead Sponsor: Centre for Endocrinology and Reproductive Medicine, Italy

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2012-10-17
• Study First Submitted QC: 2012-10-17
• Study First Posted: 2012-10-18
• Study Start: 2012-11
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-25
• Last Update Posted: 2016-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 80

Inclusion Criteria

• women with PCOS
• previous OHSS
• Infertility

Exclusion Criteria

• more than 38 years old
• Body mass index pore than 30
• other systemic diseases

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cetrorelix 0.25mg	cetrorelix 0.25mg	patients treated with gonadotropin and Cetrorelix ina flexible GnRH antagonist protocol
degarelix group	degarelix (long acting GnRH antagonist)	group of patients treated with long acting GnRH antagonist

Primary Outcome Measures

Name	Time	Method
PREGNANCY RATE	6 MONTHS	number of ongoing pregnancy obtained in the group
ovarian hyperstimulation syndrome rate	6 MONTHS	incidence of ovarian hyperstimulation syndrome in the groups

Secondary Outcome Measures

Name	Time	Method
implantation rate	6 months	number of implanted embryos divided for the number of transferred embryos

Trial Locations

Locations (1)

Cerm-Hungaria; 🇮🇹 Rome, Italy