Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2026-01-10 @ 3:29 PM
Study NCT ID:
NCT03116867
Status:
UNKNOWN
Last Update Posted:
2017-04-17
First Post:
2017-04-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sonosalpingography After Hysteroscopic Tubal Occlusion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 56}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2018-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-04-12', 'studyFirstSubmitDate': '2017-04-05', 'studyFirstSubmitQcDate': '2017-04-12', 'lastUpdatePostDateStruct': {'date': '2017-04-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The presence of fluid in douglas pouch detected by transvaginal ultrasound after saline infusion through the cervix', 'timeFrame': 'immediate', 'description': 'after saline infusion is done, presence of fluid in douglas pouch means that hysteroscopic occlusion of tubes was not successful.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Fallopian Tube Occlusion']}, 'descriptionModule': {'briefSummary': 'Sonosalpingography is done to assess the efficacy of hysteroscopic tubal occlusion by roller ball electrode.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'patients requiring tubal occlusion', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Infertile patients with hydrosalpinges requiring in vitro fertilization\n* irreversible contraception\n\nExclusion Criteria:\n\n* Acute pelvic inflammatory disease'}, 'identificationModule': {'nctId': 'NCT03116867', 'briefTitle': 'Sonosalpingography After Hysteroscopic Tubal Occlusion', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Sonosalpingography in Assessment of Efficacy of Hysteroscopic Tubal Occlusion by Roller Ball Electrode', 'orgStudyIdInfo': {'id': 'Ainshams528'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'patients receiving hysteroscopic tubal occlusion', 'description': 'This group will have sonosalpingography done for them one month after the tubal occlusion.', 'interventionNames': ['Other: sonosalpingography']}], 'interventions': [{'name': 'sonosalpingography', 'type': 'OTHER', 'description': 'transvaginal ultrasound with saline infusion', 'armGroupLabels': ['patients receiving hysteroscopic tubal occlusion']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Sherif H Hussain, MD', 'role': 'CONTACT'}], 'facility': 'Ain Shams Maternity Hospital', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Sherif H Hussain, MD', 'role': 'CONTACT', 'email': 'docsherif77@yahoo.com', 'phone': '0201005219239'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Sherif Hanafi Hussain', 'investigatorAffiliation': 'Ain Shams University'}}}}