Endometrial Biopsy in Infertile Patients

Tracking Information
First Submitted Date ICMJE	July 15, 2003
First Posted Date ICMJE	July 16, 2003
Last Update Posted Date	June 24, 2005
Study 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; (submitted: June 23, 2005)	880
Original Enrollment ICMJE	Same as current
Study 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