Endometrial Biopsy in Infertile Patients
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ClinicalTrials.gov Identifier: NCT00064935 |
Recruitment Status
:
Completed
First Posted
: July 16, 2003
Last Update Posted
: June 24, 2005
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Tracking Information | ||||
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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. |
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Study Type ICMJE | Interventional | |||
Study Phase | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Factorial Assignment Masking: Double Primary Purpose: Diagnostic |
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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. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Enrollment ICMJE |
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)
Inclusion Criteria for Infertile Patients
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Sex/Gender |
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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 |
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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 |
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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 |