Ignite Creation Date:
2025-12-24 @ 7:11 PM
Ignite Modification Date:
2026-02-27 @ 8:07 AM
Study NCT ID:
NCT04389203
Status:
UNKNOWN
Last Update Posted:
2023-11-27
First Post:
2020-05-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pregnancy Rate After Unilateral Tubal Disconnection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D011247', 'term': 'Pregnancy'}, {'id': 'D020554', 'term': 'Sperm Injections, Intracytoplasmic'}], 'ancestors': [{'id': 'D012098', 'term': 'Reproduction'}, {'id': 'D055703', 'term': 'Reproductive Physiological Phenomena'}, {'id': 'D012101', 'term': 'Reproductive and Urinary Physiological Phenomena'}, {'id': 'D005307', 'term': 'Fertilization in Vitro'}, {'id': 'D027724', 'term': 'Reproductive Techniques, Assisted'}, {'id': 'D012099', 'term': 'Reproductive Techniques'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Unilateral tubal disconnection and spontaneous pregnancy'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 110}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2024-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-23', 'studyFirstSubmitDate': '2020-05-12', 'studyFirstSubmitQcDate': '2020-05-12', 'lastUpdatePostDateStruct': {'date': '2023-11-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pregnancy rate', 'timeFrame': '2 years', 'description': 'Number of pregnant women after procedure'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pregnancy rate', 'Lasparosocpy', 'Unilateral tubal disconnection', 'Intracytoplasmic sperm injection'], 'conditions': ['Pregnancy Rate']}, 'descriptionModule': {'briefSummary': 'Unilateral disconnection of one tube that had hydrosalpinx', 'detailedDescription': 'In cases suffering from infertility and all other factors were normal except hysterosalpingogram that showed hydrosalpinx.\n\nWe either did intracytoplasmic sperm injection (ICSI) in one group and spontaneous follow up for 2 years after laparoscopy Pregnancy rate in both groups was assessed'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* infertile women either primary or secondary Hydrosalpinx\n\nExclusion Criteria:\n\n* other factors of infertility'}, 'identificationModule': {'nctId': 'NCT04389203', 'briefTitle': 'Pregnancy Rate After Unilateral Tubal Disconnection', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'Pregnancy Rate After Laparoscopic Unilateral Tubal Disconnection', 'orgStudyIdInfo': {'id': 'PRAUTD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Study group', 'description': 'Unilateral tubal disconnection and waiting for pregnancy for 2 years after laparoscopy', 'interventionNames': ['Procedure: Unilateral tubal disconnection + Spontaneous follow up for pregnancy']}, {'type': 'EXPERIMENTAL', 'label': 'Control group', 'description': 'Unilateral tubal disconnection and ICSI', 'interventionNames': ['Procedure: Unilateral tubal disconnection + ICSI']}], 'interventions': [{'name': 'Unilateral tubal disconnection + Spontaneous follow up for pregnancy', 'type': 'PROCEDURE', 'description': 'Unilateral tubal disconnection + Spontaneous follow up for pregnancy', 'armGroupLabels': ['Study group']}, {'name': 'Unilateral tubal disconnection + ICSI', 'type': 'PROCEDURE', 'description': 'Unilateral tubal disconnection + ICSI', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31111', 'city': 'Tanta', 'state': 'Gharbia Governorate', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Adel Elgergawy, MD', 'role': 'CONTACT', 'email': 'dradelali775@gmail.com', 'phone': '+201002057250'}], 'facility': 'Adel Elgergawy', 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': '6 months', 'ipdSharing': 'YES', 'description': 'When we finish the results'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanta University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Ayman S Dawood, MD', 'investigatorAffiliation': 'Tanta University'}}}}