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

Tracking Information
First Received Date ^ICMJE	October 1, 2009
Last Updated Date	October 1, 2009
Start Date ^ICMJE	May 2000
Primary Completion Date	March 2004 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	No Changes Posted
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Randomized Study on Endometrioma Treatment
Official Title ^ICMJE	Not Provided
Brief Summary	This is a randomised study comparing the effect of two laparoscopic techniques for treatment of ovarian endometriomas on recurrence rate and ovarian reserve.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Intervention Model: Parallel Assignment
Condition ^ICMJE	Ovarian Endometrioma
Intervention ^ICMJE	Procedure: Laser treatment of ovarian endometrioma Laser vaporization of ovarian endometrioma
Study Arm (s)	Experimental: Laser treatment Intervention: Procedure: Laser treatment of ovarian endometrioma Active Comparator: Endometrioma cystectomy Intervention: Procedure: Laser treatment of ovarian endometrioma
Publications *	Carmona F, Martínez-Zamora MA, Rabanal A, Martínez-Román S, Balasch J. Ovarian cystectomy versus laser vaporization in the treatment of ovarian endometriomas: a randomized clinical trial with a five-year follow-up. Fertil Steril. 2011 Jul;96(1):251-4. Epub 2011 May 14.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	Not Provided
Completion Date	March 2004
Primary Completion Date	March 2004 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Female
Ages	18 Years to 40 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Spain

Administrative Information
NCT Number ^ICMJE	NCT00989118
Other Study ID Numbers ^ICMJE	endometriomatreatment
Has Data Monitoring Committee	No
Responsible Party	Not Provided
Study Sponsor ^ICMJE	Hospital Clinic of Barcelona
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Hospital Clinic of Barcelona
Verification Date	October 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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