[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100595114":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":26,"centralContacts":31,"locations":39,"responsibleParty":51,"collaborators":10,"id":53,"slug":54,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":59,"eligibilityCriteria":60,"healthyVolunteers":55,"sex":61,"minAge":62,"maxAge":63,"enrollmentInfo":64,"targetDuration":10,"studyType":67,"phases":10,"briefSummary":68,"conditions":69,"keywords":10,"overallStatus":73,"whyStopped":10,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":79,"leadSponsor":81,"locationsCount":82},{"fullName":5,"class":6},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Retrospective",null,"This group includes patients with a histological diagnosis of atypical endometrial hyperplasia (AEH) or endometrioid endometrial carcinoma (EEC) G1-G2 who underwent hysteroscopic fertility-sparing surgery and medical treatment starting from January 2023. These patients were retrospectively identified from the Hysteroscopic Treatments Database. Only those with pre-treatment transvaginal ultrasound imaging available were included.",[13],"Procedure: Hysteroscopic fertility-sparing surgery and hormonal treatment",{"label":15,"type":10,"description":16,"interventionNames":17},"Prospective","This group includes reproductive-age women newly diagnosed with AEH or EEC G1-G2, confirmed by endometrial biopsy during diagnostic hysteroscopy, who are eligible and consenting for fertility-sparing treatment. Patients undergo baseline clinical assessment, transvaginal ultrasound, and MRI prior to hysteroscopic surgery. Fertility-sparing treatment includes hysteroscopic endometrial resection, intrauterine device (IUD) placement and\u002For oral progestin therapy, followed by monitoring with serial biopsies and ultrasound at 3, 6, and 12 months.",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"PROCEDURE","Hysteroscopic fertility-sparing surgery and hormonal treatment","Patients undergo hysteroscopic endometrial resection using the Mazzon \"three-step\" technique or tissue removal device (TRD), depending on the lesion type. Following surgery, hormonal treatment is administered either via intrauterine device (IUD) or oral progestin. Monitoring includes serial endometrial biopsies and transvaginal ultrasounds at 3, 6, and 12 months.",[15,9],[25],"Endometrial resection Hormonal therapy Intrauterine device (IUD) placement Oral progestin therapy",[27],{"name":28,"affiliation":29,"role":30},"Antonia Carla Testa","Fondazione Policlinico Universitario Agostino Gemelli","PRINCIPAL_INVESTIGATOR",[32,36],{"name":28,"role":33,"phone":34,"phoneExt":10,"email":35},"CONTACT","0630156399","antoniacarla.testa@policlinicogemelli.it",{"name":37,"role":33,"phone":34,"phoneExt":10,"email":38},"Federica Pozzati","federica.pozzati@guest.policlinicogemelli.it",[40],{"facility":5,"status":10,"city":41,"state":10,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":10},"Roma","00168","Italy","IT",{"type":46,"coordinates":47},"Point",[48,49],11.10642,44.99364,{"lat":49,"lon":48},{"type":52,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100595114","ultrasound-and-histology-in-aeh-and-early-eec-treated-conservatively-100595114",false,"NCT07028242","Ultrasound and Histology in AEH and Early EEC Treated Conservatively","Ultrasound and Histological Features of Patients With Atypical Endometrial Hyperplasia and Early Endometrioid Endometrial Carcinoma Submitted to Fertility Sparing Treatment.","ULTRA-SAFE","Inclusion Criteria:\n\nWomen aged 18-45 years.\n\nHistologically confirmed atypical endometrial hyperplasia (AEH) or endometrioid endometrial carcinoma (EEC) G1-2.\n\nCandidates for fertility-sparing treatment (hysteroscopic resection and\u002For progestin therapy).\n\nNo prior history of invasive endometrial carcinoma.\n\nAdequate endometrial visualization via transvaginal ultrasound (TVUS) and\u002For MRI.\n\nSigned informed consent for study participation.\n\nExclusion Criteria:\n\nWomen under 18 or over 45 years.\n\nPresence of myometrial invasion on MRI or histological analysis.\n\nHistological diagnosis of serous carcinoma, clear cell carcinoma, or undifferentiated carcinoma.\n\nHistory of previous hysterectomy or non-conservative surgical treatment.\n\nContraindications to hormonal therapy (e.g., thromboembolic disease, hormone-dependent malignancies).\n\nPregnancy at the time of enrollment.\n\nLack of adequate imaging for ultrasound-based assessment.","FEMALE","18 Years","45 Years",{"count":65,"type":66},50,"ESTIMATED","OBSERVATIONAL","Ultra-S.A.F.E. is a multicenter, ambispective observational study investigating the ultrasound and histological characteristics of patients with atypical endometrial hyperplasia (AEH) or endometrioid endometrial carcinoma (EEC) G1-2 undergoing fertility-sparing treatment (FST). The study aims to describe pre-treatment ultrasound features, evaluate endometrial modifications during treatment, and assess histological and reproductive outcomes. It includes a prospective cohort (new patients recruited at three gynecologic oncology centers) and a retrospective cohort (patients treated conservatively since January 2023). Approximately 50 patients will be enrolled over 24 months, with clinical, ultrasound, and histological data collected. The ultimate goal is to enhance the diagnostic and monitoring role of transvaginal ultrasound (TVUS) in conservative treatment for fertility preservation.",[70,71,72],"Fertility-Sparing Treatment (FST)","Atypical Endometrial Hyperplasia","Early Endometrial Cancer (EEC)","NOT_YET_RECRUITING","2025-06-11",{"date":76,"type":77},"2025-06-19","ACTUAL",{"date":74,"type":66},{"date":80,"type":66},"2027-06-30",{"name":5,"class":6},1]