[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100655197":3},{"organization":4,"outcomesModule":7,"designInfo":14,"detailedDescription":13,"studyPopulation":17,"armGroups":18,"interventions":13,"overallOfficials":13,"centralContacts":34,"locations":40,"responsibleParty":54,"collaborators":13,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":64,"eligibilityCriteria":65,"healthyVolunteers":60,"sex":66,"minAge":67,"maxAge":68,"enrollmentInfo":69,"targetDuration":72,"studyType":73,"phases":13,"briefSummary":74,"conditions":75,"keywords":82,"overallStatus":43,"whyStopped":13,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"Semmelweis University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":13},[9],{"measure":10,"description":11,"timeFrame":12},"Diagnostic accuracy of the AI algorithm for detection of endometriosis and adenomyosis on transvaginal ultrasound","Sensitivity, specificity, and area under the receiver operating characteristic curve (AUC) of the AI-based detection algorithm for endometriosis and adenomyosis, assessed against the reference standard of surgical findings and histopathological confirmation (for participants undergoing surgery) or, where surgery is not performed, expert consensus review of the standardized ultrasound examination.","3 years",null,{"allocation":13,"interventionModel":13,"interventionModelDescription":13,"primaryPurpose":13,"observationalModel":15,"timePerspective":16,"maskingInfo":13},"COHORT","PROSPECTIVE","The study population comprises patients aged 18-45 years who attend the Department of Obstetrics and Gynecology at Semmelweis University. A total of 1600 participants will be enrolled: 1200 for the endometriosis\u002Fadenomyosis cohort, 200 for the myometrial mass dignity-prediction cohort, and 200 for the cohort addressing other benign infertility-related conditions and AR\u002FIVF outcome prediction.",[19,22,25,28,31],{"label":20,"type":13,"description":21,"interventionNames":13},"Endometriosis cohort","Women aged 18-45 years with clinical suspicion of endometriosis, in whom the diagnosis is subsequently confirmed by laparoscopy or laparotomy with histological analysis of the resected specimen (peritoneal, ovarian, or deep infiltrating endometriosis). No intervention is administered; participants undergo a standardized transvaginal ultrasound examination (IDEA protocol) and complete clinical and quality-of-life questionnaires (NRS, EHP-30) as part of routine care.",{"label":23,"type":13,"description":24,"interventionNames":13},"Ademyosis cohort","Women aged 18-45 years with clinical suspicion of adenomyosis, assessed by standardized transvaginal ultrasound (MUSA protocol) for direct and indirect sonographic features, morphological subtype, and severity. No intervention is administered; assessment occurs as part of routine gynecological care.",{"label":26,"type":13,"description":27,"interventionNames":13},"Myometrial mass cohort","Women aged 18-45 years with a previously confirmed uterine leiomyoma scheduled for surgical treatment. Participants undergo standardized ultrasound assessment of leiomyoma location, size, and sonographic features prior to surgery, with post-surgical histopathological correlation. No intervention is administered beyond standard-of-care surgical treatment already planned.",{"label":29,"type":13,"description":30,"interventionNames":13},"Uterine malformation cohort","Women aged 18-45 years undergoing ultrasound examination for suspected congenital (Müllerian) uterine anomaly or other intracavitary uterine pathology. Participants undergo standardized ultrasound assessment; no intervention is administered.",{"label":32,"type":13,"description":33,"interventionNames":13},"Endometrial receptivity cohort","Women aged 18-45 years scheduled for IVF treatment or embryo transfer, without confirmed uterine or endometrial pathology other than adenomyosis. Participants undergo standardized ultrasound assessment of endometrial thickness, morphology, and vascularity (IETA protocol) around the window of implantation, linked to subsequent assisted reproduction treatment and pregnancy outcome. No intervention is administered.",[35],{"name":36,"role":37,"phone":38,"phoneExt":13,"email":39},"Nandor Acs, PhD","CONTACT","+3620825001","acs.nandor@semmelweis.hu",[41],{"facility":42,"status":43,"city":44,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":13},"Department of Obstetrics and Gynecology, Semmelweis University","RECRUITING","Budapest","1088","Hungary","HU",{"type":49,"coordinates":50},"Point",[51,52],19.04045,47.49835,{"lat":52,"lon":51},{"type":55,"investigatorFullName":56,"investigatorTitle":57,"investigatorAffiliation":5,"oldNameTitle":13,"oldOrganization":13},"PRINCIPAL_INVESTIGATOR","Dr. Ács Nándor","Head of Department of Obstetrics and Gynecology","100655197","artificial-intelligence-into-ultrasound-diagnostics-in-reproductive-medicine-100655197",false,"NCT07810920","Artificial Intelligence Into Ultrasound Diagnostics in Reproductive Medicine","Innovation for Women's Health: the Integration of Artificial Intelligence in the Diagnostic Ultrasound Assessment of Reproductive Medicine","AUDRIE","Inclusion Criteria:\n\n* Women aged 18-45 years with clinical suspicion of endometriosis or adenomyosis, in whom the diagnosis of endometriosis is subsequently confirmed, including peritoneal, ovarian, and deep infiltrating endometriosis. The diagnosis is established by imaging, laparoscopy, or laparotomy, based on characteristic intraoperative findings and histological analysis (#Enzian classification).\n* Women undergoing ultrasound examination for suspected congenital uterine anomaly or other intracavitary uterine pathology.\n* Women with previously confirmed leiomyoma scheduled for surgical treatment.\n* Women scheduled for IVF treatment or embryo transfer.\n* Willingness and capacity to provide written informed consent prior to enrolment.\n\nExclusion Criteria:\n\n* TVUS is not technically feasible.\n* Postmenopausal status.\n* Pregnancy.\n* Puerperium (up to 3 months postpartum).\n* Suspected premalignancy, or presence or history of malignancy.\n* Chronic comorbidities, including uncontrolled diabetes mellitus, severe cardiovascular or respiratory disease, systemic autoimmune disease, or uncontrolled thyroid dysfunction.\n* Other conditions, including psychiatric illness or substance use, and any circumstance in which study participation could pose a risk to the patient, or in which enrolment could bias the study results.\n* For the endometrial receptivity sub-study, confirmed uterine or endometrial pathology other than adenomyosis.","FEMALE","18 Years","45 Years",{"count":70,"type":71},1600,"ESTIMATED","3 Years","OBSERVATIONAL","The goal of this observational study is to develop and validate artificial intelligence (AI)-based algorithms that support ultrasound diagnosis of endometriosis, adenomyosis, myometrial masses, uterine malformations, and impaired endometrial receptivity in women aged 18-45 years. The main questions it aims to answer are:\n\nCan AI algorithms, applied to standardized transvaginal ultrasound images, accurately detect and classify endometriosis and adenomyosis in real time during routine examination? Can AI-based ultrasound assessment predict the histological dignity of myometrial masses, and the likelihood of successful assisted reproduction (AR\u002FIVF) outcome from endometrial features?\n\nParticipants attending the Department of Obstetrics and Gynecology, Semmelweis University, with clinical suspicion of endometriosis or adenomyosis, a confirmed myometrial mass scheduled for surgery, a suspected uterine anomaly, or scheduled IVF treatment, will undergo standardized transvaginal ultrasound examination (following the IDEA, MUSA, and IETA protocols) alongside collection of clinical, questionnaire, and, where surgery is performed, histopathological data. Imaging and clinical data will be used to build a database supporting the development and validation of the AI algorithms.",[76,77,78,79,80,81],"Endometriosis","Adenomyosis of Uterus","Leiomyoma (Uterine Fibroids)","Uterine Neoplasms","Congenital Abnormalities","Infertility, Female",[83,84,85,86,87,88,89],"reproductive medicine","artificial intelligence","deep learning","endometriosis","endometrial receptivity","adenomyosis","uterine leiomyoma","2026-09-15",{"date":92,"type":93},"2026-09-18","ACTUAL",{"date":95,"type":93},"2026-09-01",{"date":97,"type":71},"2030-12-31",{"name":5,"class":6},1]