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

April 25, 2016 updated by: Fabio Scarpellini, Centre for Endocrinology and Reproductive Medicine, Italy

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

80

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Rome, Italy, 00153
        • Cerm-Hungaria

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 34 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • cetrotide

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PREGNANCY RATE
Time Frame: 6 MONTHS
number of ongoing pregnancy obtained in the group
6 MONTHS
ovarian hyperstimulation syndrome rate
Time Frame: 6 MONTHS
incidence of ovarian hyperstimulation syndrome in the groups
6 MONTHS

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
implantation rate
Time Frame: 6 months
number of implanted embryos divided for the number of transferred embryos
6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
number of mature oocytes
Time Frame: 6 months
number of mature oocytes obtained in each patient
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre for Endocrinology and Reproductive Medicine, Italy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

October 17, 2012

First Submitted That Met QC Criteria

October 17, 2012

First Posted (Estimate)

October 18, 2012

Study Record Updates

Last Update Posted (Estimate)

April 27, 2016

Last Update Submitted That Met QC Criteria

April 25, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C05

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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