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

Phase 3
25 Years
39 Years
Not Enrolling

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Trial Information

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

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.

Inclusion Criteria

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double-Blind, Primary Purpose: Diagnostic

Principal Investigator

Evan Myers, MD, MPH

Investigator Role:

Principal Investigator

Investigator Affiliation:

Duke University Medical Center and Duke Clinical Research Institute


United States: Federal Government

Study ID:




Start Date:

April 1999

Completion Date:

February 2002

Related Keywords:

  • Infertility
  • Endometrium
  • Luteal phase
  • Endometrial biopsy
  • Infertility
  • Adenoma



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