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)

July 15, 2003
July 16, 2003
June 24, 2005
April 1999
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Endometrial Biopsy in Infertile Patients
Utility of the Endometrial Biopsy in the Evaluation of the Luteal Phase
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.

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.

Phase 3
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double
Primary Purpose: Diagnostic
Procedure: Endometrial biopsy
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
February 2002
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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
Sexes Eligible for Study: Female
25 Years to 39 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
United States
U01HD038997( U.S. NIH Grant/Contract )
U01HD038997 ( U.S. NIH Grant/Contract )
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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
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
May 2003

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP