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

History of Changes

Tracking Information

First Received Date ^ICMJE

July 15, 2003

Last Updated Date

June 23, 2005

Start Date ^ICMJE

April 1999

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Endometrial Biopsy in Infertile Patients

Official Title ^ICMJE

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

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double
Primary Purpose: Diagnostic

Condition ^ICMJE

Infertility

Intervention ^ICMJE

Procedure: Endometrial biopsy

Study Arms

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

880

Estimated Completion Date

February 2002

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Sex/Gender

Sexes Eligible for Study:

Female

Ages

25 Years to 39 Years (Adult)

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00064935

Other Study ID Numbers ^ICMJE

U01HD038997( U.S. NIH Grant/Contract )
U01HD038997 ( U.S. NIH Grant/Contract )
NICHD-0803

Has Data Monitoring Committee

Not Provided

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

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

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Evan Myers, MD, MPH

Duke University Medical Center and Duke Clinical Research Institute

PRS Account

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

Verification Date

May 2003

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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