GnRH Antagonist to Prepare Recipients for Embryo Transfer

May 24, 2010 updated by: Institute for Human Reproduction (IHR)

Use of GnRH Antagonist (Cetrotide) Protocol, Instead of Agonist, to Prepare Recipients for Embryo Transfer

26% of all ART cycles performed in the USA in 2003 (CDC data) are frozen embryo transfers (FET) and transfer of embryos resulting from egg donation (ED) to recipients. The typical protocol used to prepare a recipient for ET involves GnRH agonist (Lupron, Tap Pharmaceuticals) to down regulate the patient. A GnRH antagonist, such as Cetrotide (EMD Serono), is comparable to GnRH agonist and FDA approved to prevent spontaneous ovulation with ART treatment, and its usage decreases significantly the number of injections that the patient receives with treatment. The working hypothesis for this study is that the GnRH antagonist (Cetrotide) can be used instead of an agonist to achieve effective down regulation in FET and ED cycles. Presumably, patients will prefer Cetrotide over Lupron because of the markedly fewer injections required.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

130

Phase

  • Not Applicable

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

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60657
        • Institute for Human Reproduction (IHR)
      • Oakbrook Terrace, Illinois, United States, 60181
        • Institute for Human Reproduction (IHR)

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

20 years to 50 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • History of infertility before cryopreserving the embryos or inability to conceive from her own oocytes (based on age and/or a serum FSH > 15 IU/L).
  • Any patient desiring to become pregnant as a result of transferring frozen-thawed embryos generated using her own or donor oocytes.
  • Subject is in good health as determined by the Investigator on the basis of medical history, physical examination and laboratory screening tests.
  • A negative pregnancy test prior to starting treatment with estrogens.

Exclusion Criteria:

  • Women with a history of liver and/or kidney disease
  • Hypertension: systolic pressure over 180 mm Hg or diastolic pressure over 105 at any study visit, measured twice 6 hours apart despite active treatment for hypertension.
  • Liver function tests of two times than the upper limit of normal
  • Women with active sever endometriosis.

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: CROSSOVER
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Clinical Pregnancy Rate

Secondary Outcome Measures

Outcome Measure
Delivery Rate

Collaborators and Investigators

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

Sponsor

Institute for Human Reproduction (IHR)

Investigators

  • Principal Investigator: Ilan Tur-Kaspa, MD, President and Medical Director, Institute for Human Reproduction (IHR) and Director, Clinical IVF-PGD Program, Reproductive Genetics Institute (RGI).

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.

Helpful Links

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, 2007

Primary Completion (ACTUAL)

October 1, 2009

Study Completion (ACTUAL)

December 1, 2009

Study Registration Dates

First Submitted

April 12, 2007

First Submitted That Met QC Criteria

April 13, 2007

First Posted (ESTIMATE)

April 16, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

May 26, 2010

Last Update Submitted That Met QC Criteria

May 24, 2010

Last Verified

May 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IND 74,817

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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