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


Phase 3
25 Years
39 Years
Not Enrolling
Female
Infertility

Thank you

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:

Interventional

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

Authority:

United States: Federal Government

Study ID:

U01HD38997

NCT ID:

NCT00064935

Start Date:

April 1999

Completion Date:

February 2002

Related Keywords:

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

Name

Location
Baylor College of Medicine Houston, Texas  77030
University of Alabama Birmingham, Alabama  
University of Colorado Denver, Colorado  80217
University of Pennsylvania Philadelphia, Pennsylvania  19104
Wayne State University Detroit, Michigan  48202
University of Texas Southwestern Medical Center Dallas, Texas  
Pennsylvania State University Hershey, Pennsylvania  17033
University of Medicine and Dentistry, NJ Newark, New Jersey  07103