NCT00064935

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
880

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Apr 1999

Typical duration for phase_3

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 1999

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2002

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

July 15, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 16, 2003

Completed
Last Updated

June 24, 2005

Status Verified

May 1, 2003

First QC Date

July 15, 2003

Last Update Submit

June 23, 2005

Conditions

Infertility

Keywords

EndometriumLuteal phaseEndometrial biopsy

Interventions

Endometrial biopsyPROCEDURE

Eligibility Criteria

Age25 Years - 39 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

University of Alabama

Birmingham, Alabama, 35249, United States

Location

University of Colorado

Denver, Colorado, 80262, United States

Location

Wayne State University

Detroit, Michigan, 48201, United States

Location

University of Medicine and Dentistry, NJ

Newark, New Jersey, 07103, United States

Location

Pennsylvania State University

Hershey, Pennsylvania, 17033, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Evan Myers, MD, MPH

    Duke University Medical Center and Duke Clinical Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
DIAGNOSTIC
Intervention Model
FACTORIAL
Sponsor Type
NIH

Study Record Dates

First Submitted

July 15, 2003

First Posted

July 16, 2003

Study Start

April 1, 1999

Study Completion

February 1, 2002

Last Updated

June 24, 2005

Record last verified: 2003-05

Locations

US(8)