Endometrial Biopsy in Infertile Patients

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.

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Key information

Conditions

Infertility Genital Diseases Urogenital Diseases

Age range

25 year–39 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

University of Alabama, Birmingham, Alabama, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

endometrial biopsy

Procedure

Sponsors and collaborators

Lead sponsor

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

Nih

Registry information

Official study title

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

Important dates

Study start: 1999
Study completion: 2002
First posted: Jul 16, 2003
Registry last updated: Jun 24, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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