Endometrial Biopsy in Infertile Patients - Full Text View

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 III

MedlinePlus related topics:

Infertility

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Randomized, Double-Blind, Active Control, Factorial Assignment, Efficacy Study

Official Title:	Utility of the Endometrial Biopsy in the Evaluation of the Luteal Phase

Further study details as provided by 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

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
	University of Pennsylvania
	Philadelphia, Pennsylvania, United States, 19104
	Pennsylvania State University
	Hershey, Pennsylvania, United States, 17033

United States, Texas
	Baylor College of Medicine
	Houston, Texas, United States, 77030
	University of Texas Southwestern Medical Center
	Dallas, Texas, United States, 75390

Sponsors and Collaborators

National Institute of Child Health and Human Development (NICHD)

Investigators


Principal Investigator:	Evan Myers, MD, MPH	Duke University Medical Center and Duke Clinical Research Institute

More Information

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

Keywords provided by National Institute of Child Health and Human Development (NICHD):

Endometrium

Luteal phase

Endometrial biopsy

Study placed in the following topic categories:

Genital Diseases, Female

Infertility

Genital Diseases, Male

ClinicalTrials.gov processed this record on October 17, 2008

Sponsored by:	National Institute of Child Health and Human Development (NICHD)
Information provided by:	National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:	NCT00064935