Endometrial Biopsy in Infertile Patients

This study has been completed.
Sponsor:
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00064935
First received: July 15, 2003
Last updated: June 23, 2005
Last verified: May 2003

July 15, 2003
June 23, 2005
April 1999
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Complete list of historical versions of study NCT00064935 on ClinicalTrials.gov Archive Site
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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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double-Blind
Primary Purpose: Diagnostic
Infertility
Procedure: Endometrial biopsy
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
880
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
Female
25 Years to 39 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00064935
U01HD38997, U01 HD 38997, NICHD-0803
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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