NCT01022372

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2009

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

November 30, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 1, 2009

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

May 10, 2011

Status Verified

July 1, 2010

Enrollment Period

1.6 years

First QC Date

November 30, 2009

Last Update Submit

May 9, 2011

Conditions

Women in the Reproductive Age GroupUndergoing Laparoscopy for Pelvic Pain and/or InfertilityNot Currently Receiving Hormonal Treatment for at Least 3 Months Prior to Laparoscopy.

Outcome Measures

Primary Outcomes (1)

  • The density of nerve fibers in the endometrial biopsy sample.

    1 year

Study Arms (3)

control group

Procedure: Endometrial biopsy

endometriosis group

Procedure: Endometrial biopsy

endometrioma group

Procedure: Endometrial biopsy

Interventions

Endometrial biopsyPROCEDURE

For all the groups

control groupendometrioma groupendometriosis group

Eligibility Criteria

Age17 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The hospital of Meram medical Faculty

Konya, Turkey (Türkiye)

Location

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 30, 2009

First Posted

December 1, 2009

Study Start

November 1, 2009

Primary Completion

June 1, 2011

Study Completion

December 1, 2011

Last Updated

May 10, 2011

Record last verified: 2010-07

Locations

TU(1)