Randomized Study on Endometrioma Treatment

NCT ID: NCT00989118

Last Updated: 2009-10-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2000-05-31

Study Completion Date

2004-03-31

Brief Summary

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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

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Conditions

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Ovarian Endometrioma

Study Design

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Intervention Model

PARALLEL

Study Groups

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Laser treatment

Group Type EXPERIMENTAL

Laser treatment of ovarian endometrioma

Intervention Type PROCEDURE

Laser vaporization of ovarian endometrioma

Endometrioma cystectomy

Group Type ACTIVE_COMPARATOR

Laser treatment of ovarian endometrioma

Intervention Type PROCEDURE

Laser vaporization of ovarian endometrioma

Interventions

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Laser treatment of ovarian endometrioma

Laser vaporization of ovarian endometrioma

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Hospital Clinic of Barcelona

OTHER

Sponsor Role lead

Locations

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Hospital Clinic

Barcelona, Barcelona, Spain

Site Status

Countries

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Spain

References

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Carmona F, Martinez-Zamora MA, Rabanal A, Martinez-Roman 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. doi: 10.1016/j.fertnstert.2011.04.068. Epub 2011 May 14.

Reference Type DERIVED
PMID: 21575941 (View on PubMed)

Other Identifiers

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endometriomatreatment

Identifier Type: -

Identifier Source: org_study_id

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