Ignite Creation Date:
2025-12-24 @ 4:36 PM
Ignite Modification Date:
2026-02-25 @ 4:48 PM
Study NCT ID:
NCT03777566
Status:
UNKNOWN
Last Update Posted:
2019-12-23
First Post:
2018-12-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Uterine Cavity Volume Measuring With Sonohysterography: A New Objective Method
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 185}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-02-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2020-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-12-20', 'studyFirstSubmitDate': '2018-12-14', 'studyFirstSubmitQcDate': '2018-12-14', 'lastUpdatePostDateStruct': {'date': '2019-12-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'calculation of uterine cavity volume with an objective method', 'timeFrame': 'one day', 'description': 'measuring uterine cavity volume objectively'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cavity']}, 'descriptionModule': {'briefSummary': 'Measuring of uterine cavity volume using sonohysterography will be done in two groups of patients, Group A included 35 patients for home hysterectomy were indicated and group B includes 150 infertile patients in the childbearing age.', 'detailedDescription': 'Uterine cavity volume will be measured in group A before and after hysterectomy, and in the group, B will be measured using sonohysterography only using a mathematical method of the sum of a volume of a cone and part of a sphere.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Women undergo sonohysterography for gynecologic indication without gross uterine pathology.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients without any gross pathology within the uterus.\n2. Patients admitted for hysterectomy.\n3. Patients agreed with written consent to participate in the study.\n\nExclusion Criteria:\n\n1. Virgins.\n2. Pregnancy.\n3. Systemic blood disease.\n4. Any clinical evidence of cervical, uterine or tubal infection.\n5. Refusal to undergo saline infusion sonography.\n6. Any gross uterine pathology diagnosed clinically or with sonography.'}, 'identificationModule': {'nctId': 'NCT03777566', 'briefTitle': 'Uterine Cavity Volume Measuring With Sonohysterography: A New Objective Method', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Uterine Cavity Volume Measuring With Sonohysterography: A New Objective Method', 'orgStudyIdInfo': {'id': 'mohamed amer'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'group A', 'description': '35 patients with an indication for hysterectomy without gross uterine pathology', 'interventionNames': ['Diagnostic Test: sonohysterography']}, {'label': 'group B', 'description': '150 infertile patients in the childbearing age without gross uterine pathology', 'interventionNames': ['Diagnostic Test: sonohysterography']}], 'interventions': [{'name': 'sonohysterography', 'type': 'DIAGNOSTIC_TEST', 'description': 'sonohysterography with measuring the uterine cavity volume', 'armGroupLabels': ['group A', 'group B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11357', 'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Mohamed Amer, MD', 'role': 'CONTACT', 'email': 'mohamed_amer810@yahoo.com', 'phone': '00201001519370'}], 'facility': 'AIn Shams University Maternity Hospital', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Mohamed I Amer, MD', 'role': 'CONTACT', 'email': 'mohamed_amer810@yahoo.com', 'phone': '00201001519370'}], 'overallOfficials': [{'name': 'Mohamed I Amer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ain Shams University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Mohamed I Amer', 'investigatorAffiliation': 'Ain Shams University'}}}}