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

This study is currently recruiting participants.
Verified December 2012 by Centre for Endocrinology and Reproductive Medicine, Italy
Sponsor:
Information provided by (Responsible Party):
Fabio Scarpellini, Centre for Endocrinology and Reproductive Medicine, Italy
ClinicalTrials.gov Identifier:
NCT01709942
First received: October 17, 2012
Last updated: December 20, 2012
Last verified: December 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
PCOS
OHSS
INFERTILITY
 Drug: degarelix (long acting GnRH antagonist)
Drug: cetrorelix 0.25mg
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Use of Long Acting GnRH Antagonist to Prevent Ovarian HyperStimulation Syndrome (OHSS) in PCOS Women Undergoing COH for IVF

Resource links provided by NLM:

MedlinePlus related topics: Infertility
U.S. FDA Resources

Further study details as provided by Centre for Endocrinology and Reproductive Medicine, Italy:

Primary Outcome Measures:
  • PREGNANCY RATE [ Time Frame: 6 MONTHS ] [ Designated as safety issue: No ]
    number of ongoing pregnancy obtained in the group

  • ovarian hyperstimulation syndrome rate [ Time Frame: 6 MONTHS ] [ Designated as safety issue: Yes ]
    incidence of ovarian hyperstimulation syndrome in the groups


Secondary Outcome Measures:
  • implantation rate [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    number of implanted embryos divided for the number of transferred embryos


Other Outcome Measures:
  • number of mature oocytes [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    number of mature oocytes obtained in each patient


Estimated Enrollment: 80
Study Start Date: November 2012
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: degarelix group
group of patients treated with long acting GnRH antagonist
 Drug: degarelix (long acting GnRH antagonist)
20 mg of degarelix the first day of menstrual cycle before starting with gonadotrophins administration
Other Name: Firmagon
Active Comparator: Cetrorelix 0.25mg
patients treated with gonadotropin and Cetrorelix ina flexible GnRH antagonist protocol
 Drug: cetrorelix 0.25mg
0.25mg of cetrorelix during treatment with gonadotrophins when estradiol levels were >300pg/ml
Other Name: cetrotide

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.

  Eligibility

Ages Eligible for Study:   20 Years to 38 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01709942

Locations
Italy
Cerm-Hungaria Recruiting
Rome, Italy, 00153
Contact: Marco Sbracia, MD     +393479037433     marcandrea@hotmail.com    
Contact: Fabio Scarpellini, MD     +393278779064     quelidebercia@hotmail.com    
Principal Investigator: Marco Sbracia, MD            
Sub-Investigator: Fabio Scarpellini, MD            
Sponsors and Collaborators
Centre for Endocrinology and Reproductive Medicine, Italy
Investigators
Study Chair: Marco Sbracia, MD Centre for Endocrinology and Reproductive Medicine, Italy
  More Information

Publications:

Responsible Party: Fabio Scarpellini, Principal Investigator, Centre for Endocrinology and Reproductive Medicine, Italy
ClinicalTrials.gov Identifier: NCT01709942     History of Changes
Other Study ID Numbers: C05
Study First Received: October 17, 2012
Last Updated: December 20, 2012
Health Authority: Italy: Ministry of Health

Keywords provided by Centre for Endocrinology and Reproductive Medicine, Italy:
GnRH antagonist
PCOS
OHSS
COH
IVF

Additional relevant MeSH terms:
Infertility
Polycystic Ovary Syndrome
Ovarian Hyperstimulation Syndrome
Genital Diseases, Male
Genital Diseases, Female
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
 Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases
Cetrorelix
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013