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Clinical Trials/NCT00064935
NCT00064935
Completed
Phase 3

Utility of the Endometrial Biopsy in the Evaluation of the Luteal Phase

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)8 sites in 1 country880 target enrollmentApril 1999
ConditionsInfertility

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Infertility
Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Enrollment
880
Locations
8
Status
Completed
Last Updated
20 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
April 1999
End Date
February 2002
Last Updated
20 years ago
Study Type
Interventional
Study Design
Factorial
Sex
Female

Investigators

Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Not specified

Study Sites (8)

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