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Endometrial Biopsy in Infertile Patients

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. Identifier: NCT00064935
Recruitment Status : Completed
First Posted : July 16, 2003
Last Update Posted : June 24, 2005
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Brief Summary:
When a woman becomes pregnant, the fertilized egg attaches itself to the lining of the uterus (endometrium). The endometrium is constantly changing throughout a woman’s menstrual cycle in response to the female hormones estrogen and progesterone. The endometrium must have certain characteristics (be at a specific phase in its cycle) in order for the fertilized egg to successfully attach. Infertility may be caused by an "out of phase" endometrium (i.e., the endometrium doesn’t have the right characteristics when the fertilized egg reaches it). The purpose of this study is to evaluate whether the endometrial biopsy is useful in predicting the potential for becoming pregnant and bearing a child.

Condition or disease Intervention/treatment Phase
Infertility Procedure: Endometrial biopsy Phase 3

Detailed Description:

This study will evaluate the utility of the endometrial biopsy as a tool for the routine evaluation of the luteal phase of women presenting for infertility evaluation. The study will establish whether the mid-luteal or late-luteal phase is the most appropriate time to perform an endometrial biopsy. The study will be conducted through the multi-center Reproductive Medicine Network.

Women with a history of infertility will be age matched to fertile women (controls). Women will be randomized either to the mid-luteal phase (7 to 8 days post-ovulation) endometrial biopsy group or to the late-luteal phase (12 to 13 days post-ovulation) endometrial biopsy group. Endometrial specimens will be evaluated histologically by a "blinded" pathologist.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 880 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double
Primary Purpose: Diagnostic
Official Title: Utility of the Endometrial Biopsy in the Evaluation of the Luteal Phase
Study Start Date : April 1999
Study Completion Date : February 2002

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy Infertility

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   25 Years to 39 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria for Fertile Patients (controls)

  • No history of involuntary primary or secondary infertility
  • Willingness to discontinue hormonal contraceptives for 1 month prior to and through the duration of the study
  • At least 1 child delivered within 24 months prior to study entry
  • Most recent pregnancy resulting in a live birth (no interim spontaneous abortions)
  • Tubal ligation within 24 months of study entry is acceptable if all other criteria are met

Inclusion Criteria for Infertile Patients

  • History of primary or secondary infertility for a period of at least 12 months
  • No hormonal treatments in the month preceding study entry
  • No history of tubal ligation

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 identifier (NCT number): NCT00064935

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United States, Alabama
University of Alabama
Birmingham, Alabama, United States, 35249
United States, Colorado
University of Colorado
Denver, Colorado, United States, 80262
United States, Michigan
Wayne State University
Detroit, Michigan, United States, 48201
United States, New Jersey
University of Medicine and Dentistry, NJ
Newark, New Jersey, United States, 07103
United States, Pennsylvania
Pennsylvania State University
Hershey, Pennsylvania, United States, 17033
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Baylor College of Medicine
Houston, Texas, United States, 77030
Sponsors and Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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Principal Investigator: Evan Myers, MD, MPH Duke University Medical Center and Duke Clinical Research Institute
Layout table for additonal information Identifier: NCT00064935    
Other Study ID Numbers: U01HD038997 ( U.S. NIH Grant/Contract )
U01HD038997 ( U.S. NIH Grant/Contract )
First Posted: July 16, 2003    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: May 2003
Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
Luteal phase
Endometrial biopsy
Additional relevant MeSH terms:
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Genital Diseases, Male
Genital Diseases, Female