Administration of GnRH Antagonist to Oocyte Donation Recipients (GnRH-Ovodon)

March 6, 2008 updated by: Centro Ginecologia y Obstetricia.

Administration of GnRH Antagonist to Oocyte Donation Recipients During Endometrial Preparation.

This prospective and randomized study was performed to evaluate whether the replacement of GnRH agonist by a GnRH antagonist in oocyte donation recipients during endometrial preparation has any impact on pregnancy and implantation rates.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This was a prospective and randomized study undertaken between January 2004 and December 2007. One hundred patients with an indication for oocyte donation with functioning ovaries and IVF with or without intracytoplasmatic sperm injection (ICSI) were recruited for the study. After assignment to IVF or IVF/ICSI randomization was performed to 1 of the 2 treatment groups (GnRH agonist or GnRH antagonist during endometrial preparation in oocyte donation recipients) using a computed-generated randomization schedule assigned via numbered sealed envelopes.

In our program, we used excess oocytes from IVF that were voluntarily donated by patients after informed consent.

The indications for oocyte donation were reduced ovarian reserve (59%), recurrent IVF failures (21%), premature ovarian failure (16%), and genetic anomaly (4%).

This study was performed according to the declaration of Helsinki and the European Community note on Good Clinical Practice for trials on medical products in the European Community (CPMP Working Party on Efficacy of Medical Products, 1990). Furthermore, the local ethics committee approved the study protocol, and written informed consent was obtained from all patients.

Study Type

Observational

Enrollment (Actual)

100

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

  • Spain
      • Valencia, Spain, 46004
        • CEGIOB

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 32 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Patients with an indication for oocyte donation with functioning ovaries.

Description

Inclusion Criteria:

  • Age between 18-34 years
  • Body mass index between 19-30 kg/m2;
  • History of regular menstrual cycles, ranging from 25-35 days
  • No relevant systemic disease (all patients were screened for hepatitis B and C, human immunodeficiency viruses I and II, syphylis, and vaginal infection), genetic disease, severe endometriosis or pelvic inflamatory disease
  • No more than two previous IVF cycles; and
  • No previous IVF cycles with poor response (less than three oocytes in a previous IVF cycle) or severe ovarian hyperstimulation syndrome.

Exclusion Criteria:

  • Patients without inclusion criteria.

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: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
GnRH-ant
Patients were treated with a GnRH antagonist (Orgalutran®; 0,25 mg/d, sc.) commencing on day 1 of the menstrual cycle and maintained until the day of donor's hCG administration.
Drug: GnRH antagonist (Orgalutran®)
GnRH antagonist (Orgalutran®; 0,25 mg/d, sc.) commencing on day 1 of the menstrual cycle and maintained until the day of donor's hCG administration.
Other Names:
  • GnRH antagonist
GnRH-a
GnRH long protocol using 0.1 mg/day triptorelin s.c (Decapeptyl®, Ipsen Pharma, Barcelona, Spain) was started on day 21-24 of the preceding cycle for at least 14 days to produce an agonadal state. Furthermore, the triptorelin administration was maintained until the day of donor's hCG administration.
Drug: triptorelin (Decapeptyl®, Ipsen Pharma, Barcelona, Spain)
0.1 mg/day triptorelin s.c (Decapeptyl®, Ipsen Pharma, Barcelona, Spain) was started on day 21-24 of the preceding cycle for at least 14 days to produce an agonadal state.
Other Names:
  • GnRH agonist

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
pregnancy and implantation rates
Time Frame: "at 7 weeks"
"at 7 weeks"

Secondary Outcome Measures

Outcome Measure
Time Frame
age of the recipients, body mass index, days undergoing oestrogen therapy
Time Frame: "at 1 mounth"
"at 1 mounth"

Collaborators and Investigators

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

Sponsor

Centro Ginecologia y Obstetricia.

Collaborators

University of Valencia

Investigators

  • Principal Investigator: Raga Francisco, M.D., Ph.D., Centro Ginecologia y Obstetricia.

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

January 1, 2004

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

February 26, 2008

First Submitted That Met QC Criteria

March 6, 2008

First Posted (Estimate)

March 13, 2008

Study Record Updates

Last Update Posted (Estimate)

March 13, 2008

Last Update Submitted That Met QC Criteria

March 6, 2008

Last Verified

March 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GnRH-ant.Ovodon

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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