NCT00989118

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.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started May 2000

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

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

May 1, 2000

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2004

Completed
5.6 years until next milestone

First Submitted

Initial submission to the registry

October 1, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 2, 2009

Completed
Last Updated

October 2, 2009

Status Verified

October 1, 2009

Enrollment Period

3.8 years

First QC Date

October 1, 2009

Last Update Submit

October 1, 2009

Conditions

Ovarian Endometrioma

Study Arms (2)

Laser treatment

EXPERIMENTAL
Procedure: Laser treatment of ovarian endometrioma

Endometrioma cystectomy

ACTIVE COMPARATOR
Procedure: Laser treatment of ovarian endometrioma

Interventions

Laser treatment of ovarian endometriomaPROCEDURE

Laser vaporization of ovarian endometrioma

Endometrioma cystectomyLaser treatment

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Clinic

Barcelona, Barcelona, 08036, Spain

Location

Related Publications (1)

  • 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.

    PMID: 21575941DERIVED

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Design

Study Type
interventional
Phase
phase 3
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 1, 2009

First Posted

October 2, 2009

Study Start

May 1, 2000

Primary Completion

March 1, 2004

Study Completion

March 1, 2004

Last Updated

October 2, 2009

Record last verified: 2009-10

Locations

ES(1)