Endometrial Biopsy as Diagnostic Method for Endometriosis and Endometrioma
The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by Selcuk University.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Selcuk University
Information provided by:
Selcuk University
ClinicalTrials.gov Identifier:
NCT01022372
First received: November 30, 2009
Last updated: May 9, 2011
Last verified: July 2010
| Tracking Information | |
|---|---|
| First Received Date ICMJE | November 30, 2009 |
| Last Updated Date | May 9, 2011 |
| Start Date ICMJE | November 2009 |
| Estimated Primary Completion Date | June 2011 (final data collection date for primary outcome measure) |
| Current Primary Outcome Measures ICMJE |
The density of nerve fibers in the endometrial biopsy sample. [ Time Frame: 1 year ] [ Designated as safety issue: No ] |
| Original Primary Outcome Measures ICMJE | Same as current |
| Change History | Complete list of historical versions of study NCT01022372 on ClinicalTrials.gov Archive Site |
| 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 as Diagnostic Method for Endometriosis and Endometrioma |
| Official Title ICMJE | The Evaluation of Endometrial Biopsy in the Diagnosis of Endometriosis and Endometrioma: a Double Blind Study |
| Brief Summary | Our aim was to evaluate the efficacy of examining endometrial biopsy specimens for nerve fibers as a diagnostic test for endometriosis and endometrioma in a double-blind comparison with diagnostic laparoscopy. |
| Detailed Description | Not Provided |
| Study Type ICMJE | Observational |
| Study Design ICMJE | Observational Model: Case Control Time Perspective: Prospective |
| Target Follow-Up Duration | Not Provided |
| Biospecimen | Not Provided |
| Sampling Method | Non-Probability Sample |
| Study Population | women in the reproductive age group undergoing laparoscopy for pelvic pain and/or infertility, and not currently receiving hormonal treatment for at least 3 months prior to laparoscopy will be included in the study. |
| Condition ICMJE |
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| Intervention ICMJE | Procedure: Endometrial biopsy
For all the groups |
| Study Group/Cohort (s) |
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| 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 | Active, not recruiting |
| Estimated Enrollment ICMJE | 60 |
| Estimated Completion Date | December 2011 |
| Estimated Primary Completion Date | June 2011 (final data collection date for primary outcome measure) |
| Eligibility Criteria ICMJE | Inclusion Criteria:
|
| Gender | Female |
| Ages | 17 Years to 45 Years |
| Accepts Healthy Volunteers | No |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | Turkey |
| Administrative Information | |
| NCT Number ICMJE | NCT01022372 |
| Other Study ID Numbers ICMJE | 2009035 |
| Has Data Monitoring Committee | Not Provided |
| Responsible Party | Alaa S.MAHMOUD, SELCUK UNIVERSITY- MERAM MEDICAL FACULTY |
| Study Sponsor ICMJE | Selcuk University |
| Collaborators ICMJE | Not Provided |
| Investigators ICMJE | Not Provided |
| Information Provided By | Selcuk University |
| Verification Date | July 2010 |
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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