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GnRH Antagonist to Prepare Recipients for Embryo Transfer

This study has been completed.
Sponsor:
Information provided by:
Institute for Human Reproduction (IHR)
ClinicalTrials.gov Identifier:
NCT00460642
First received: April 12, 2007
Last updated: May 24, 2010
Last verified: May 2010
  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: 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 [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Delivery Rate [ Designated as safety issue: No ]

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

Ages Eligible for Study:   20 Years to 50 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

ClinicalTrials.gov Identifier: NCT00460642     History of Changes
Other Study ID Numbers: IND 74,817
Study First Received: April 12, 2007
Last Updated: May 24, 2010
Health Authority: United States: Food and Drug Administration

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, Female
Genital Diseases, Male
Cetrorelix
Fertility Agents
Fertility Agents, Female
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014