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GnRH Antagonist to Prepare Recipients for Embryo Transfer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00460642
First Posted: April 16, 2007
Last Update Posted: May 26, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Institute for Human Reproduction (IHR)
  Purpose
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.

Condition Intervention
Infertility Drug: GnRH Antagonist (Cetrotide)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Use of GnRH Antagonist (Cetrotide) Protocol, Instead of Agonist, to Prepare Recipients for Embryo Transfer

Resource links provided by NLM:


Further study details as provided by Institute for Human Reproduction (IHR):

Primary Outcome Measures:
  • Clinical Pregnancy Rate

Secondary Outcome Measures:
  • Delivery Rate

Estimated Enrollment: 130
Study Start Date: January 2007
Study Completion Date: December 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00460642


Locations
United States, Illinois
Institute for Human Reproduction (IHR)
Chicago, Illinois, United States, 60657
Institute for Human Reproduction (IHR)
Oakbrook Terrace, Illinois, United States, 60181
Sponsors and Collaborators
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).
  More Information

Additional Information:
ClinicalTrials.gov Identifier: NCT00460642     History of Changes
Other Study ID Numbers: IND 74,817
First Submitted: April 12, 2007
First Posted: April 16, 2007
Last Update Posted: May 26, 2010
Last Verified: May 2010

Keywords provided by Institute for Human Reproduction (IHR):
Frozen embryo transfers (FET).
Egg donation (ED).
IVF.
ART.
Implantation.
GnRH antagonist.
Cetrotide.
Endometrial response.
Infertility treatments:
Transfer of embryos from egg donation (ED) to recipients.

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female
Cetrorelix
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Physiological Effects of Drugs
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists