Ignite Creation Date:
2025-12-24 @ 2:56 PM
Ignite Modification Date:
2026-01-04 @ 5:22 AM
Study NCT ID:
NCT01888159
Status:
UNKNOWN
Last Update Posted:
2013-06-27
First Post:
2013-06-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Salpingectomy vs Tubal Sterilisation in Low Risk for Ovarian Cancer Women and Its Effect on Ovarian Reserve
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010051', 'term': 'Ovarian Neoplasms'}], 'ancestors': [{'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'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': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013246', 'term': 'Sterilization, Tubal'}], 'ancestors': [{'id': 'D013509', 'term': 'Gynecologic Surgical Procedures'}, {'id': 'D013519', 'term': 'Urogenital Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D013245', 'term': 'Sterilization, Reproductive'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2013-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-06', 'lastUpdateSubmitDate': '2013-06-25', 'studyFirstSubmitDate': '2013-06-20', 'studyFirstSubmitQcDate': '2013-06-25', 'lastUpdatePostDateStruct': {'date': '2013-06-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-06-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Follicle Stimulation Hormone (FSH)', 'timeFrame': '3 months'}, {'measure': 'Follicle Stimulation Hormone (FSH)', 'timeFrame': '1 year'}], 'primaryOutcomes': [{'measure': 'Anti-Mullerian hormone (AMH)and Follicle Stimulation Hormone (FSH)', 'timeFrame': '3 months'}], 'secondaryOutcomes': [{'measure': 'Anti-Mullerian hormone (AMH)', 'timeFrame': '1 year'}, {'measure': 'Operative time', 'timeFrame': 'Postoperatively'}, {'measure': 'Complications', 'timeFrame': '3 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Ovarian Cancer']}, 'descriptionModule': {'briefSummary': 'Randomised study to investigate if salpingectomies done to women wishing tubal sterilisation has an effect on ovarian reserve.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women seeking for tubal sterilisation\n\nExclusion Criteria:\n\n* women older than 45\n* family history of ovarian cancer\n* presence of menopausal symptoms\n* irregular cycles\n* Hormone Replacement Therapy or hormone contraceptions the last 3 months\n* history of previous ovarian or uterine surgeries\n* imaging suggesting an ovarian cyst or other adnexal pathology during investigation\n* previous salpingectomy'}, 'identificationModule': {'nctId': 'NCT01888159', 'briefTitle': 'Salpingectomy vs Tubal Sterilisation in Low Risk for Ovarian Cancer Women and Its Effect on Ovarian Reserve', 'organization': {'class': 'OTHER', 'fullName': 'Karlstad Central Hospital'}, 'orgStudyIdInfo': {'id': 'SEvsTSinAMH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Tubal Sterilization with bipolar', 'description': 'Salpingectomy vs Tubal Sterilisation', 'interventionNames': ['Procedure: Tubal sterilization with bipolar energy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Bilateral Salpingectomy', 'description': 'Salpingectomy vs Tubal Sterilisation', 'interventionNames': ['Procedure: Bilateral Salpingectomy']}], 'interventions': [{'name': 'Bilateral Salpingectomy', 'type': 'PROCEDURE', 'armGroupLabels': ['Bilateral Salpingectomy']}, {'name': 'Tubal sterilization with bipolar energy', 'type': 'PROCEDURE', 'armGroupLabels': ['Tubal Sterilization with bipolar']}]}, 'contactsLocationsModule': {'locations': [{'zip': '65185', 'city': 'Karlstad', 'state': 'Värmaland', 'country': 'Sweden', 'facility': 'Department of Obstetrics and Gynecology', 'geoPoint': {'lat': 59.3793, 'lon': 13.50357}}], 'centralContacts': [{'name': 'Leonidas Magarakis, MD', 'role': 'CONTACT', 'email': 'lemagarakis@gmail.com', 'phone': '046737529929'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karlstad Central Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Leonidas Magarakis', 'investigatorAffiliation': 'Karlstad Central Hospital'}}}}