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
  Purpose

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.


Condition Intervention Phase
Infertility
Procedure: Endometrial biopsy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double-Blind
Primary Purpose: Diagnostic
Official Title: Utility of the Endometrial Biopsy in the Evaluation of the Luteal Phase

Resource links provided by NLM:


Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Estimated Enrollment: 880
Study Start Date: April 1999
Estimated Study Completion Date: February 2002
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.

  Eligibility

Ages Eligible for Study:   25 Years to 39 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00064935

Locations
United States, Alabama
University of Alabama
Birmingham, Alabama, United States, 35249
United States, Colorado
University of Colorado
Denver, Colorado, United States, 80262
United States, Michigan
Wayne State University
Detroit, Michigan, United States, 48201
United States, New Jersey
University of Medicine and Dentistry, NJ
Newark, New Jersey, United States, 07103
United States, Pennsylvania
Pennsylvania State University
Hershey, Pennsylvania, United States, 17033
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Baylor College of Medicine
Houston, Texas, United States, 77030
Sponsors and Collaborators
Investigators
Principal Investigator: Evan Myers, MD, MPH Duke University Medical Center and Duke Clinical Research Institute
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00064935     History of Changes
Other Study ID Numbers: U01HD38997, U01 HD 38997, NICHD-0803
Study First Received: July 15, 2003
Last Updated: June 23, 2005
Health Authority: United States: Federal Government

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
Endometrium
Luteal phase
Endometrial biopsy

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on July 31, 2014