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

INFERTILITY Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01709942
• Other study ID #: C05
• Status: Completed
• Phase: Phase 3
• First received: October 17, 2012
• Last updated: April 25, 2016
• Start date: November 2012
• Est. completion date: December 2015

Study information

• Verified date: April 2016
• Source: Centre for Endocrinology and Reproductive Medicine, Italy
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 38 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• INFERTILITY
• OHSS
• Ovarian Hyperstimulation Syndrome
• PCOS

Intervention

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

Locations

Country	Name	City	State
Italy	Cerm-Hungaria	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Centre for Endocrinology and Reproductive Medicine, Italy

Country where clinical trial is conducted

Italy, 

References & Publications (1)

García-Velasco JA, Kupesic S, Pellicer A, Bourgain C, Simón C, Mrazek M, Devroey P, Arce JC. Follicular and endocrine profiles associated with different GnRH-antagonist regimens: a randomized controlled trial. Reprod Biomed Online. 2012 Feb;24(2):153-62. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	number of mature oocytes	number of mature oocytes obtained in each patient	6 months	No
Primary	PREGNANCY RATE	number of ongoing pregnancy obtained in the group	6 MONTHS	No
Primary	ovarian hyperstimulation syndrome rate	incidence of ovarian hyperstimulation syndrome in the groups	6 MONTHS	Yes
Secondary	implantation rate	number of implanted embryos divided for the number of transferred embryos	6 months	No