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

NCT ID: NCT01709942

Last Updated: 2016-04-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2015-12-31

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.

Conditions

PCOS; OHSS; INFERTILITY

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

degarelix group

group of patients treated with long acting GnRH antagonist

Group Type: EXPERIMENTAL

degarelix (long acting GnRH antagonist)

Intervention Type: DRUG

20 mg of degarelix the first day of menstrual cycle before starting with gonadotrophins administration

Cetrorelix 0.25mg

patients treated with gonadotropin and Cetrorelix ina flexible GnRH antagonist protocol

Group Type: ACTIVE_COMPARATOR

cetrorelix 0.25mg

Intervention Type: DRUG

0.25mg of cetrorelix during treatment with gonadotrophins when estradiol levels were \>300pg/ml

Interventions

degarelix (long acting GnRH antagonist)

20 mg of degarelix the first day of menstrual cycle before starting with gonadotrophins administration

Intervention Type: DRUG

cetrorelix 0.25mg

0.25mg of cetrorelix during treatment with gonadotrophins when estradiol levels were \>300pg/ml

Intervention Type: DRUG

Other Intervention Names

Firmagon; cetrotide

Eligibility Criteria

Inclusion Criteria

• women with PCOS
• previous OHSS
• Infertility

Exclusion Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 38 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Centre for Endocrinology and Reproductive Medicine, Italy

NETWORK

Sponsor Role: lead

Responsible Party

Fabio Scarpellini

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marco Sbracia, MD

Role: STUDY_CHAIR

Centre for Endocrinology and Reproductive Medicine, Italy

Locations

Cerm-Hungaria

Rome, , Italy

Countries

Italy

References

Garcia-Velasco JA, Kupesic S, Pellicer A, Bourgain C, Simon 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. doi: 10.1016/j.rbmo.2011.10.016. Epub 2011 Nov 4.

Reference Type: RESULT

PMID: 22197127 (View on PubMed)

Other Identifiers

C05

Identifier Type: -

Identifier Source: org_study_id