Ignite Creation Date:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2026-02-23 @ 12:20 PM
Study NCT ID:
NCT03788720
Status:
NOT_YET_RECRUITING
Last Update Posted:
2021-04-29
First Post:
2018-10-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Suture of the Ovary After Enucleation of Ovarian Endometrioma
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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Surgeons who perform the surgery will be not masked for the treatment allocation.\n\nEvaluators (sonographers, data analyzers) will be blind for the treatment allocation.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized Controlled Trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2027-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-04-28', 'studyFirstSubmitDate': '2018-10-11', 'studyFirstSubmitQcDate': '2018-12-26', 'lastUpdatePostDateStruct': {'date': '2021-04-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Antral Follicle Count (AFC)', 'timeFrame': 'Change from day 3 of the menstrual cycle prior to the elective laparoscopic surgery to day 3 of the menstrual cycle after to the elective laparoscopic surgery', 'description': 'AFC will be evaluated on day 3 of the cycle by a transvaginal ultrasound. Initially the ovarian volume of both the ovaries is calculated. Further the number of small antral follicles in both the ovaries is measured. These follicles could vary in size from 2-10 mm.'}], 'secondaryOutcomes': [{'measure': 'Pulsatility index, evaluated by Doppler flowmetry, of the ovarian artery', 'timeFrame': 'Change from day 3 of the menstrual cycle prior to the elective laparoscopic surgery to day 3 of the menstrual cycle after to the elective laparoscopic surgery', 'description': 'Evaluation of the pulsatility index (PI; minimum: 0; maximum: 7; higher values represent a better outcome) of the ovarian artery.'}, {'measure': 'Resistive index, evaluated by Doppler flowmetry, of the ovarian artery', 'timeFrame': 'Change from day 3 of the menstrual cycle prior to the elective laparoscopic surgery to day 3 of the menstrual cycle after to the elective laparoscopic surgery', 'description': 'Evaluation of the resistive index (RI minimum: 0; maximum: 3; higher values represent a worse outcome) of the ovarian artery.'}, {'measure': 'Ovarian volume', 'timeFrame': 'Change from day 3 of the menstrual cycle prior to the elective laparoscopic surgery to day 3 of the menstrual cycle after to the elective laparoscopic surgery', 'description': 'Evaluation of the ovarian volume calculated using the prolate ellipsoid formula (length x height x width x 0.523)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Endometrioma', 'Laparoscopy', 'Suture', 'Ovary'], 'conditions': ['Endometrioma']}, 'descriptionModule': {'briefSummary': 'Endometriosis is an estrogen-dependent chronic disease, characterized by the presence of ectopic endometrial-like tissue outside the uterine cavity.\n\nAccording to the most updated guidelines of the European Society of Human Reproduction and Embryology (ESHRE), infertile women with endometriomas smaller than 3 cm should be addressed directly to Assisted Reproduction Technology (ART); conversely, for infertile women with endometriomas larger than 3 cm, enucleation of ovarian endometriomas could be considered in order to improve reproductive outcomes (both spontaneous and ART pregnancy rate).\n\nTo date, literature data do not allow to draw a firm conclusion about the best strategy to reduce ovarian damage during enucleation of ovarian endometriomas: in particular, investigators still lack robust evidence in order to choose between suturing the ovary or not after the enucleation.\n\nIn this scenario, the aim of our the study will be to compare functional outcomes of the ovary in a group of women undergoing suturing of the ovarian cortex after laparoscopic enucleation of endometriomas (cases) and a group of women undergoing laparoscopic enucleation of endometriomas without subsequent suture of the ovarian cortex.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women affected by one primary (no recurrent) monolateral ovarian endometrioma, with maximum diameter between 5 and 10 cm, undergoing laparoscopic enucleation by stripping technique;\n* Normal AFC at the enrollment (baseline).\n\nExclusion Criteria:\n\n* Any other disease;\n* Bilateral endometriomas;\n* Deep infiltrating endometriosis;\n* No previous pelvic surgery (even not gynecological);\n* Any other pharmacologic and non pharmacologic treatment in the previous 3 months (wash-out period);'}, 'identificationModule': {'nctId': 'NCT03788720', 'acronym': 'SOAVE-1', 'briefTitle': 'Suture of the Ovary After Enucleation of Ovarian Endometrioma', 'organization': {'class': 'OTHER', 'fullName': "Università degli Studi dell'Insubria"}, 'officialTitle': 'Comparison Between Suture of the Ovary Versus no Suture After Enucleation of Ovarian Endometrioma', 'orgStudyIdInfo': {'id': 'SOAVE-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Suture', 'description': 'Women undergoing suturing of the ovarian cortex after laparoscopic enucleation of endometriomas.', 'interventionNames': ['Procedure: Suture of the ovarian cortex']}, {'type': 'SHAM_COMPARATOR', 'label': 'No suture', 'description': 'Women undergoing laparoscopic enucleation of endometriomas without subsequent suture of the ovarian cortex.', 'interventionNames': ['Procedure: No suture of the ovarian cortex']}], 'interventions': [{'name': 'Suture of the ovarian cortex', 'type': 'PROCEDURE', 'description': 'Suture of the ovarian cortex after laparoscopic enucleation of endometriomas, using one single monofilament suture material, continuous suture technique with maximum 5 transfixion of the ovarian cortex and intracorporeal knots only (no extracorporeal knots).', 'armGroupLabels': ['Suture']}, {'name': 'No suture of the ovarian cortex', 'type': 'PROCEDURE', 'description': 'Laparoscopic enucleation of endometriomas without suture of the ovarian cortex', 'armGroupLabels': ['No suture']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21100', 'city': 'Varese', 'country': 'Italy', 'contacts': [{'name': 'Antonio Simone Laganà, M.D.', 'role': 'CONTACT', 'email': 'antoniosimone.lagana@asst-settelaghi.it', 'phone': '+393296279579'}, {'name': 'Davide Sturla, M.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Giulia Bordi, M.D.', 'role': 'SUB_INVESTIGATOR'}], 'facility': '"Filippo Del Ponte" Hospital', 'geoPoint': {'lat': 45.82058, 'lon': 8.82511}}], 'centralContacts': [{'name': 'Antonio Simone Laganà, M.D.', 'role': 'CONTACT', 'email': 'antoniosimone.lagana@asst-settelaghi.it', 'phone': '+393296279579'}], 'overallOfficials': [{'name': 'Antonio Simone Laganà, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Università degli Studi dell'Insubria"}, {'name': 'Fabio Ghezzi, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': "Università degli Studi dell'Insubria"}, {'name': 'Jvan Casarin, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Università degli Studi dell'Insubria"}, {'name': 'Simone Garzon', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Università degli Studi dell'Insubria"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Università degli Studi dell'Insubria", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Antonio Simone Laganà', 'investigatorAffiliation': "Università degli Studi dell'Insubria"}}}}