[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100644931":3},{"organization":4,"outcomesModule":7,"designInfo":35,"detailedDescription":34,"studyPopulation":38,"armGroups":34,"interventions":34,"overallOfficials":34,"centralContacts":39,"locations":45,"responsibleParty":60,"collaborators":34,"id":62,"slug":34,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":65,"acronym":66,"eligibilityCriteria":67,"healthyVolunteers":63,"sex":68,"minAge":69,"maxAge":70,"enrollmentInfo":71,"targetDuration":34,"studyType":74,"phases":34,"briefSummary":75,"conditions":76,"keywords":34,"overallStatus":47,"whyStopped":34,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},{"fullName":5,"class":6},"IRCCS Azienda Ospedaliero-Universitaria di Bologna","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":34},[9],{"measure":10,"description":11,"timeFrame":12},"To compare the duration of procedures performed using two different techniques for endometrial biopsy in patients requiring sampling of hypotrophic or atrophic endometrium: 'chip biopsy' and 'rail biopsy'","Time required to perform the hysteroscopic endometrial biopsy technique, measured in seconds from entry into the uterine cavity to completion of the procedure itself (excluding the time needed for removal of the resected tissue), during hysteroscopy","During hysteroscopy",[14,17,21,24,28,31],{"measure":15,"description":16,"timeFrame":12},"To compare the safety of the procedure between the two endometrial biopsy techniques.","Adverse events (e.g., vasovagal syndromes, bleeding, uterine perforations, or other injuries to the uterus and surrounding organs)",{"measure":18,"description":19,"timeFrame":20},"To compare the adequacy of the tissue obtained for histological analysis between the two endometrial biopsy techniques.","Pathologist's assessment regarding specific factors (e.g., tissue quantity, absence of crushing and\u002For tearing and\u002For electrocautery artifacts and\u002For improper fixation)","Upon delivery of the histological report (within 1 month from hysteroscopy)",{"measure":22,"description":23,"timeFrame":12},"To compare the need for additional accessory instruments between the two endometrial biopsy techniques.","Number of instruments used",{"measure":25,"description":26,"timeFrame":27},"Pain intensity assessed by Visual Analog Scale (VAS)","Pain intensity measured using the Visual Analog Scale (VAS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates worst possible pain.","administered after hysteroscopy (within 24 hours)",{"measure":29,"description":30,"timeFrame":27},"Pain quality assessed by McGill Pain Questionnaire (MPQ)","Pain quality measured using the McGill Pain Questionnaire (MPQ), with total scores ranging from 0 to 78, where higher scores indicate greater pain severity.",{"measure":32,"description":33,"timeFrame":27},"Anxiety and depression assessed by Hospital Anxiety and Depression Scale (HADS)","Anxiety and depression measured using the Hospital Anxiety and Depression Scale (HADS), consisting of two subscales (anxiety and depression), each ranging from 0 to 21, where higher scores indicate greater symptom severity.",null,{"allocation":34,"interventionModel":34,"interventionModelDescription":34,"primaryPurpose":34,"observationalModel":36,"timePerspective":37,"maskingInfo":34},"COHORT","PROSPECTIVE","The recruitment of the study population will take place at the Hysteroscopy Outpatient Clinic of the Unit of Gynecology and Human Reproduction Physiopathology, IRCCS AOUBO. Patients referred to this clinic with an indication for diagnostic and\u002For operative hysteroscopy will undergo a thorough preliminary clinical evaluation to assess their eligibility for study enrollment (women with atrophic or hypotrophic endometrium requiring endometrial biopsy).",[40],{"name":41,"role":42,"phone":43,"phoneExt":34,"email":44},"Paolo Casadio, MD","CONTACT","0512144411","p.casadio@unibo.it",[46],{"facility":5,"status":47,"city":48,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"RECRUITING","Bologna","40138","Italy","IT",{"type":53,"coordinates":54},"Point",[55,56],11.33875,44.49381,{"lat":56,"lon":55},[59],{"name":41,"role":42,"phone":43,"phoneExt":34,"email":44},{"type":61,"investigatorFullName":34,"investigatorTitle":34,"investigatorAffiliation":34,"oldNameTitle":34,"oldOrganization":34},"SPONSOR","100644931",false,"NCT07675317","Comparison Between Two Hysteroscopic Biopsy Techniques in the Outpatient Setting for Sampling Hypotrophic or Atrophic Endometrium: 'Rail Biopsy' Versus 'Chip Biopsy'","HYSTEB","Inclusion Criteria:\n\n* Age ≥ 48 years and ≤ 75 years\n* Women with atrophic endometrium, candidates for endometrial biopsy\n* Informed consent obtained for participation in the study and for the processing of personal data\n\nExclusion Criteria:\n\n* Presence of intrauterine fibroids, polyps, and adhesions;\n* Current or recent (\\\u003C 3 months) use of anticoagulant drugs and\u002For Selective Estrogen Receptor Modulators (SERMs);\n* Previous confirmed diagnosis of endometrial cancer;\n* Suspected active pelvic inflammation or history of recent pelvic inflammation (\\\u003C 6 months);\n* Presence of severe stenosis or obliteration of the cervical canal.","FEMALE","48 Years","75 Years",{"count":72,"type":73},156,"ESTIMATED","OBSERVATIONAL","Hysteroscopic endometrial biopsy is one of the most common procedures in gynecology. For patients with atrophic or hypotrophic endometrium, typical of menopausal women, the \"chip biopsy\" technique is often preferred as it provides adequate tissue samples for accurate histological examination. Recently, the \"rail biopsy\" technique has also been adopted at IRCCS AOUBO for biopsies in similar cases. Currently, the choice between these techniques depends largely on operator preference and experience, as there is no strong evidence favoring one over the other in terms of efficacy, safety, or tolerability.\n\nThis observational, single-center, cross-sectional, prospective, non-profit study aims to compare the procedure duration of \"chip biopsy\" versus \"rail biopsy\" in patients requiring endometrial biopsy of atrophic or hypotrophic endometrium. The study is expected to last approximately 14 months. Approximately 156 patients will be enrolled.",[77],"Atrophic or Hypotrophic Endometrium","2026-06-26",{"date":80,"type":81},"2026-06-30","ACTUAL",{"date":83,"type":81},"2025-08-04",{"date":85,"type":73},"2026-11",{"name":5,"class":6},1]