protocolSection identificationModule nctId: NCT06309927, orgStudyIdInfo id: 0025-24-ASF, briefTitle: Operative Hysteroscopy Versus Suction Curettage for Surgical Termination of Early Pregnancy Loss (Miscarriage), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Assaf-Harofeh Medical Center, class: OTHER_GOV, descriptionModule briefSummary: Non-blinded prospective randomized study. 100 women diagnosed with early pregnancy loss up to 10 gestational weeks who opted for surgical management (after being offered the options of conservative management and medical treatment) will be recruited.Qualifying patients will sign an informed consent form and will be randomly assigned to the two arms of the study:1. Surgical uterine evacuation by the traditional ultrasound-guided suction curettage (control group)2. Surgical uterine evacuation by operative hysteroscopy using a tissue removal device (study group).The surgical procedure will be determined randomly by computer generated allocation.All surgical procedures will be performed under general anesthesia in an outpatient surgical suite. The operative time, operative blood loss and intraoperative complications will be recorded by the research team.Following the surgical procedure, the patients will be monitored and discharged home as per our department's day-surgery protocol. Immediate post-operative complications will be recorded until discharge.One week after the procedure, a telephone interview will be conducted to assess any procedure-related complications.A diagnostic hysteroscopy without anesthesia will be scheduled 6 weeks postoperatively to assess for retained products of conception and for intrauterine adhesions. The diagnostic hysteroscopy will be performed by a practitioner who will be blinded to the type of surgery performed.6 months after the procedure, a telephone questionnaire will be conducted to assess for subsequent pregnancies., conditionsModule conditions: Early Pregnancy Loss, conditions: Intrauterine Adhesion, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Operative hysteroscopy (by tissue removal device), interventions name: Suction curettage, outcomesModule primaryOutcomes measure: Operative complications, primaryOutcomes measure: Intrauterine adhesions, primaryOutcomes measure: Subsequent fertility, secondaryOutcomes measure: Conversion from operative hysteroscopy to suction curettage, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Shamir Medical Center, city: Be'er Ya'aqov, zip: 70200, country: Israel, contacts name: Noam Smorgick, MD, role: CONTACT, email: nsmorgik@shamir.gov.il, geoPoint lat: 31.93864, lon: 34.83749, hasResults: False