Long Acting GnRH Antagonist in PCOS Women Undergoing IVF

March 11, 2014 updated by: Bioroma

The Use of a Long Acting GnRH Antagonist (Degarelix) in Controlled Ovarian Hyperstimulation in PCOS Women at a Risk to Developing OHSS Undergoing IVF : a Pilot Study

PCOS is a common endocrinopathy affecting 5-10% of women in their reproductive age characterized by hyperandrogenism, chronic anovulation and polycystic ovaries. This syndrome is a serious problem in IVF since there is a high risk of developing ovarian hyperstimulation syndrome (OHSS) during ovarian stimulation with gonadotropins. The introduction of GnRH antagonist in IVF has reduced the incidence of severe OHSS, still maintaining a good ovarian response and pregnancy rate. Recently, a long acting GnRH antagonist, Degarelix, was introduced for prostatic cancer treatment. Furthermore a recent paper reported its use also for the induction of multiple follicular growth in a program of oocyte donation. The aim of this study is to evaluate the feasibility of GnRH antagonist depot use in a protocol of controlled ovarian hyperstimulation in PCOS women at risk of developing OHSS in IVF cycles.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

20

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, 00197
        • Recruiting
        • Bioroma
        • Principal Investigator:
          • Mauro Schimberni, MD

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

23 years to 37 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women with PCOS with a previous IVF attempt cancelled due to the risk of OHSS

Description

Inclusion Criteria:

  • regular menstrual cycle (26-39 days)
  • primary infertility
  • BMI < 30

Exclusion Criteria:

  • women with diabetes and other metabolic disease
  • women with heart disease
  • women with inflammatory or autoimmune disease

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
GnRH antagonist depot, Degarelix
Women receive 20 mg of Degarelix on the first day of menstrual cycle followed by a fixed dose of 225 IU of recombinant FSH on the second day until the day of ovulation triggering
Drug: GnRH antagonist depot Degarelix
Women receive 20 mg of Degarelix on the first day of menstrual cycle followed by a fixed dose of 225 IU of recombinant FSH on the second day until the day of ovulation triggering

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pregnancy rate
Time Frame: Time Frame: until 12th gestational week
Time Frame: until 12th gestational week
Incidence of OHSS
Time Frame: Time frame: until 7th gestational week
Time frame: until 7th gestational week

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of collected oocytes
Time Frame: Time Frame: until 12th gestational week
Time Frame: until 12th gestational week
Estradiol level at HCG day
Time Frame: time frame: until 12th gestational week
time frame: until 12th gestational week
Total dose of FSH administered
Time Frame: Time frame: until 12th gestational week
Time frame: until 12th gestational week
Total days of stimulation
Time Frame: Time frame: until 12th gestational week
Time frame: until 12th gestational week
implantation rate
Time Frame: time frame: until 12th gestational week
time frame: until 12th gestational week

Collaborators and Investigators

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

Sponsor

Bioroma

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

March 1, 2014

Primary Completion (Anticipated)

December 1, 2014

Study Completion (Anticipated)

February 1, 2015

Study Registration Dates

First Submitted

March 10, 2014

First Submitted That Met QC Criteria

March 11, 2014

First Posted (Estimate)

March 12, 2014

Study Record Updates

Last Update Posted (Estimate)

March 12, 2014

Last Update Submitted That Met QC Criteria

March 11, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BRM002

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.

Clinical Trials on Ovarian Hyperstimulation Syndrome

Clinical Trials on GnRH antagonist depot Degarelix

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Papua New Guinea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe