NCT01709942

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Centre for Endocrinology and Reproductive Medicine, Italy · Network
• Sex: Female
• Age: 20 Years – 38 Years
• Healthy volunteers: Not accepted

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.

Conditions

• PCOS
• OHSS
• INFERTILITY

Interventions

Type	Name	Description
DRUG	degarelix (long acting GnRH antagonist)	20 mg of degarelix the first day of menstrual cycle before starting with gonadotrophins administration
DRUG	cetrorelix 0.25mg	0.25mg of cetrorelix during treatment with gonadotrophins when estradiol levels were \>300pg/ml

Timeline

• Start date: 2012-11-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2012-10-18
• Last updated: 2016-04-27

Locations

1 site across 1 country: Italy