Randomized Study on Endometrioma Treatment

October 1, 2009 updated by: Hospital Clinic of Barcelona
This is a randomised study comparing the effect of two laparoscopic techniques for treatment of ovarian endometriomas on recurrence rate and ovarian reserve.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08036
        • Hospital Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • age between 18 and 40 years
  • uni or bilateral symptomatic endometriotic cysts with a minimum diameter of 30 millimetres
  • no counter-indication for the use of GnRH analogues

Exclusion Criteria:

  • previous pelvic surgeries
  • history of cancer
  • suspected malignancy
  • presurgical suspicion or evidence of deep endometriosis
  • presurgical suspicion or evidence of premature ovarian failure
  • use of oestrogen suppressive drugs in the preceding 6 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Interventional Model: Parallel Assignment

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Laser treatment
Procedure: Laser treatment of ovarian endometrioma
Laser vaporization of ovarian endometrioma
Active Comparator: Endometrioma cystectomy
Procedure: Laser treatment of ovarian endometrioma
Laser vaporization of ovarian endometrioma

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Clinic of Barcelona

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2000

Primary Completion (Actual)

March 1, 2004

Study Completion (Actual)

March 1, 2004

Study Registration Dates

First Submitted

October 1, 2009

First Submitted That Met QC Criteria

October 1, 2009

First Posted (Estimate)

October 2, 2009

Study Record Updates

Last Update Posted (Estimate)

October 2, 2009

Last Update Submitted That Met QC Criteria

October 1, 2009

Last Verified

October 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • endometriomatreatment

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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