Endometrial Biopsy in Infertile Patients

NCT ID: NCT00064935

Last Updated: 2005-06-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 880 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1999-04-30
• Study Completion Date: 2002-02-28

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.

Conditions

Infertility

Keywords

Endometrium; Luteal phase; Endometrial biopsy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: DOUBLE

Interventions

Endometrial biopsy

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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

• 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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 39 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

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

NIH

Sponsor Role: lead

Principal Investigators

Evan Myers, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Duke University Medical Center and Duke Clinical Research Institute

Locations

University of Alabama

Birmingham, Alabama, United States

University of Colorado

Denver, Colorado, United States

Wayne State University

Detroit, Michigan, United States

University of Medicine and Dentistry, NJ

Newark, New Jersey, United States

Pennsylvania State University

Hershey, Pennsylvania, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Baylor College of Medicine

Houston, Texas, United States

Countries

United States

Other Identifiers

U01HD038997

Identifier Type: NIH

Identifier Source: secondary_id

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NICHD-0803

Identifier Type: -

Identifier Source: secondary_id

U01HD038997

Identifier Type: NIH

Identifier Source: org_study_id

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