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Endometrial Biopsy as Diagnostic Method for Endometriosis and Endometrioma

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2010 by Selcuk University.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01022372
First Posted: December 1, 2009
Last Update Posted: May 10, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Selcuk University
  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:


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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   17 Years to 45 Years   (Child, Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01022372


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

Responsible Party: Alaa S.MAHMOUD, SELCUK UNIVERSITY- MERAM MEDICAL FACULTY
ClinicalTrials.gov Identifier: NCT01022372     History of Changes
Other Study ID Numbers: 2009035
First Submitted: November 30, 2009
First Posted: December 1, 2009
Last Update Posted: May 10, 2011
Last Verified: July 2010

Additional relevant MeSH terms:
Infertility
Endometriosis
Pelvic Pain
Genital Diseases, Male
Genital Diseases, Female
Pain
Neurologic Manifestations
Signs and Symptoms


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