[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100346284":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":42,"locations":47,"responsibleParty":67,"collaborators":26,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":72,"sex":78,"minAge":79,"maxAge":80,"enrollmentInfo":81,"targetDuration":26,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":90,"overallStatus":93,"whyStopped":26,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"Università degli Studi dell'Insubria","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Suture","EXPERIMENTAL","Women undergoing suturing of the ovarian cortex after laparoscopic enucleation of endometriomas.",[13],"Procedure: Suture of the ovarian cortex",{"label":15,"type":16,"description":17,"interventionNames":18},"No suture","SHAM_COMPARATOR","Women undergoing laparoscopic enucleation of endometriomas without subsequent suture of the ovarian cortex.",[19],"Procedure: No suture of the ovarian cortex",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","Suture of the ovarian cortex","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).",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"No suture of the ovarian cortex","Laparoscopic enucleation of endometriomas without suture of the ovarian cortex",[15],[32,35,38,40],{"name":33,"affiliation":5,"role":34},"Antonio Simone Laganà, M.D.","PRINCIPAL_INVESTIGATOR",{"name":36,"affiliation":5,"role":37},"Fabio Ghezzi, M.D.","STUDY_DIRECTOR",{"name":39,"affiliation":5,"role":34},"Jvan Casarin, M.D.",{"name":41,"affiliation":5,"role":34},"Simone Garzon",[43],{"name":33,"role":44,"phone":45,"phoneExt":26,"email":46},"CONTACT","+393296279579","antoniosimone.lagana@asst-settelaghi.it",[48],{"facility":49,"status":26,"city":50,"state":26,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"\"Filippo Del Ponte\" Hospital","Varese","21100","Italy","IT",{"type":55,"coordinates":56},"Point",[57,58],8.82511,45.82058,{"lat":58,"lon":57},[61,62,65],{"name":33,"role":44,"phone":45,"phoneExt":26,"email":46},{"name":63,"role":64,"phone":26,"phoneExt":26,"email":26},"Davide Sturla, M.D.","SUB_INVESTIGATOR",{"name":66,"role":64,"phone":26,"phoneExt":26,"email":26},"Giulia Bordi, M.D.",{"type":34,"investigatorFullName":68,"investigatorTitle":69,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Antonio Simone Laganà","Principal Investigator","100346284","suture-of-the-ovary-after-enucleation-of-ovarian-endometrioma-100346284",false,"NCT03788720","Suture of the Ovary After Enucleation of Ovarian Endometrioma","Comparison Between Suture of the Ovary Versus no Suture After Enucleation of Ovarian Endometrioma","SOAVE-1","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);","FEMALE","18 Years","35 Years",{"count":82,"type":83},100,"ESTIMATED","INTERVENTIONAL",[86],"NA","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.",[89],"Endometrioma",[89,91,9,92],"Laparoscopy","Ovary","NOT_YET_RECRUITING","2021-04-28",{"date":96,"type":97},"2021-04-29","ACTUAL",{"date":99,"type":83},"2023-05",{"date":101,"type":83},"2027-05",{"name":5,"class":6},1]