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| Tracking Information | |||||
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| First Received Date ICMJE | July 15, 2003 | ||||
| Last Updated Date | June 23, 2005 | ||||
| Start Date ICMJE | April 1999 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00064935 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| 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. |
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| 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 Phase | Phase III | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Diagnostic, Randomized, Double-Blind, Active Control, Factorial Assignment, Efficacy Study | ||||
| Condition ICMJE | Infertility | ||||
| Intervention ICMJE | Procedure: Endometrial biopsy | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 880 | ||||
| Completion Date | February 2002 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria for Fertile Patients (controls)
Inclusion Criteria for Infertile Patients
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| Gender | Female | ||||
| Ages | 25 Years to 39 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00064935 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | U01HD38997, U01 HD 38997, NICHD-0803 | ||||
| Study Sponsor ICMJE | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | ||||
| Verification Date | May 2003 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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