Endometrial Biopsy in Infertile Patients

Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00064935
• Other study ID #: U01HD038997
• Secondary ID: U01HD038997NICHD
• Status: Completed
• Phase: Phase 3
• First received: July 15, 2003
• Last updated: June 23, 2005
• Start date: April 1999
• Est. completion date: February 2002

Study information

• Verified date: May 2003
• Source: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 880
• Est. completion date: February 2002
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years to 39 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Infertility

Intervention

Procedure:
• Endometrial biopsy

Locations

Country	Name	City	State
United States	University of Alabama	Birmingham	Alabama
United States	University of Texas Southwestern Medical Center	Dallas	Texas
United States	University of Colorado	Denver	Colorado
United States	Wayne State University	Detroit	Michigan
United States	Pennsylvania State University	Hershey	Pennsylvania
United States	Baylor College of Medicine	Houston	Texas
United States	University of Medicine and Dentistry, NJ	Newark	New Jersey
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

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

Country where clinical trial is conducted

United States,