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Home > "E" Clinical Trials Conditions > Endometrial Biopsy in Infertile Patients  Endometrial Biopsy in Infertile Patients
Endometrial Biopsy in Infertile Patients
For Condition: Infertility
Status: Completed
Sponsor(s): National Institute of Child Health and Human Development (NICHD) ,
Synopsis: 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.
Details: 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:
Study Type: Interventional, Diagnostic, Randomized, Double-Blind, Active Control, Factorial Assignment, Efficacy Study
Minimum Age/Maximum Age: 25 Years/39 Years
Genders: Female
Protocol Entry 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
Total Enrollment: 880
Location and Contact Information:
Overall Study Official:
EvanMyers, Principal Investigator, Duke University Medical Center and Duke Clinical Research Institute
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
United States
Baylor College of Medicine
Houston, Texas, 77030
United States
University of Alabama
Birmingham, Alabama, 35249
United States
University of Medicine and Dentistry, NJ
Newark, New Jersey, 07103
United States
University of Colorado
Denver, Colorado, 80262
United States
Pennsylvania State University
Hershey, Pennsylvania, 17033
United States
Wayne State University
Detroit, Michigan, 48201
United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States
Additional Information:
Study ID Numbers: U01HD38997; U01 HD 38997,NICHD-0803
Study Start Date: April 1999
Record last reviewed: May 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00064935
Other Infertility Studies:
1. Endometrial Biopsy in Infertile Patients
2. Steroid Therapy in Autoimmune Premature Ovarian Failure
3. Ovarian Follicle Function in Patients with Premature Ovarian Failure
4. Treatment of Infertility in Women With Polycystic Ovary Syndrome
5. Lead, Endocrine Disruption and Reproductive Outcomes
Related Studies:
Other Infertility Clinical Trials
Other Texas Clinical Trials
Other Houston Clinical Trials
Endometrial Biopsy in Infertile Patients
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