Ignite Creation Date:
2025-12-25 @ 4:53 AM
Ignite Modification Date:
2026-03-02 @ 7:12 AM
Study NCT ID:
NCT00989118
Status:
COMPLETED
Last Update Posted:
2009-10-02
First Post:
2009-10-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Randomized Study on Endometrioma Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004715', 'term': 'Endometriosis'}], 'ancestors': [{'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'interventionModel': 'PARALLEL'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-10', 'completionDateStruct': {'date': '2004-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-10-01', 'studyFirstSubmitDate': '2009-10-01', 'studyFirstSubmitQcDate': '2009-10-01', 'lastUpdatePostDateStruct': {'date': '2009-10-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-10-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-03', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Ovarian Endometrioma']}, 'referencesModule': {'references': [{'pmid': '21575941', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': 'This is a randomised study comparing the effect of two laparoscopic techniques for treatment of ovarian endometriomas on recurrence rate and ovarian reserve.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age between 18 and 40 years\n* uni or bilateral symptomatic endometriotic cysts with a minimum diameter of 30 millimetres\n* no counter-indication for the use of GnRH analogues\n\nExclusion Criteria:\n\n* previous pelvic surgeries\n* history of cancer\n* suspected malignancy\n* presurgical suspicion or evidence of deep endometriosis\n* presurgical suspicion or evidence of premature ovarian failure\n* use of oestrogen suppressive drugs in the preceding 6 months'}, 'identificationModule': {'nctId': 'NCT00989118', 'briefTitle': 'Randomized Study on Endometrioma Treatment', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Clinic of Barcelona'}, 'orgStudyIdInfo': {'id': 'endometriomatreatment'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Laser treatment', 'interventionNames': ['Procedure: Laser treatment of ovarian endometrioma']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Endometrioma cystectomy', 'interventionNames': ['Procedure: Laser treatment of ovarian endometrioma']}], 'interventions': [{'name': 'Laser treatment of ovarian endometrioma', 'type': 'PROCEDURE', 'description': 'Laser vaporization of ovarian endometrioma', 'armGroupLabels': ['Endometrioma cystectomy', 'Laser treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08036', 'city': 'Barcelona', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Clinic', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Clinic of Barcelona', 'class': 'OTHER'}}}}