Randomized Study on Endometrioma Treatment

This study has been completed.
Sponsor:
Information provided by:
Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier:
NCT00989118
First received: October 1, 2009
Last updated: NA
Last verified: October 2009
History: No changes posted
  Purpose

This is a randomised study comparing the effect of two laparoscopic techniques for treatment of ovarian endometriomas on recurrence rate and ovarian reserve.


Condition Intervention Phase
Ovarian Endometrioma
Procedure: Laser treatment of ovarian endometrioma
Phase 3

Study Type: Interventional
Study Design: Intervention Model: Parallel Assignment

Further study details as provided by Hospital Clinic of Barcelona:

Study Start Date: May 2000
Study Completion Date: March 2004
Primary Completion Date: March 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00989118

Locations
Spain
Hospital Clinic
Barcelona, Spain, 08036
Sponsors and Collaborators
Hospital Clinic of Barcelona
  More Information

No publications provided by Hospital Clinic of Barcelona

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00989118     History of Changes
Other Study ID Numbers: endometriomatreatment
Study First Received: October 1, 2009
Last Updated: October 1, 2009
Health Authority: Spain: Comité Ético de Investigación Clínica

Additional relevant MeSH terms:
Endometriosis
Genital Diseases, Female

ClinicalTrials.gov processed this record on August 01, 2014