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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
Sponsor:
Information provided by:
Selcuk University
ClinicalTrials.gov Identifier:
NCT01022372
First received: November 30, 2009
Last updated: May 9, 2011
Last verified: July 2010
History of Changes
  Purpose

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.


Condition Intervention
Women in the Reproductive Age Group
Undergoing Laparoscopy for Pelvic Pain and/or Infertility
Not Currently Receiving Hormonal Treatment for at Least 3 Months Prior to Laparoscopy.
 Procedure: Endometrial biopsy

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: The Evaluation of Endometrial Biopsy in the Diagnosis of Endometriosis and Endometrioma: a Double Blind Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Selcuk University:

Primary Outcome Measures:
  • The density of nerve fibers in the endometrial biopsy sample. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: November 2009
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
control group Procedure: Endometrial biopsy
For all the groups
endometriosis group Procedure: Endometrial biopsy
For all the groups
endometrioma group Procedure: Endometrial biopsy
For all the groups

  Eligibility

Ages Eligible for Study:   17 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Criteria

Inclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01022372

Locations
Turkey
The hospital of Meram medical Faculty
Konya, Turkey
Sponsors and Collaborators
Selcuk University
  More Information

No publications provided

Responsible Party: Alaa S.MAHMOUD, SELCUK UNIVERSITY- MERAM MEDICAL FACULTY
ClinicalTrials.gov Identifier: NCT01022372     History of Changes
Other Study ID Numbers: 2009035
Study First Received: November 30, 2009
Last Updated: May 9, 2011
Health Authority: Turkey: Ethics Committee

Additional relevant MeSH terms:
Endometriosis
Infertility
Pelvic Pain
Adenoma
Genital Diseases, Female
Genital Diseases, Male
 Pain
Signs and Symptoms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on May 21, 2013