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NCT Number: NCT00460642

GnRH Antagonist 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.

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Key information

Conditions

Infertility Genital Diseases Urogenital Diseases

Age range

20 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Institute for Human Reproduction (IHR), Chicago, Illinois, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

GnRH Antagonist (Cetrotide)

Drug

Primary outcomes

  1. Clinical Pregnancy Rate

Secondary outcomes

  1. Delivery Rate

Sponsors and collaborators

Lead sponsor

Institute for Human Reproduction (IHR)

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Apr 16, 2007
Registry last updated
May 26, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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