Viewing Study NCT03678558


Ignite Creation Date: 2025-12-25 @ 12:16 AM
Ignite Modification Date: 2026-02-28 @ 9:43 PM
Study NCT ID: NCT03678558
Status: COMPLETED
Last Update Posted: 2019-08-07
First Post: 2018-09-17
Is Gene Therapy: True
Has Adverse Events: False

Brief Title: Oocyte Vitrification Aided With Cytochalasin B
Sponsor:
Organization:

Raw JSON

{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007246', 'term': 'Infertility'}], 'ancestors': [{'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 612}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-09-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2019-08-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-05', 'studyFirstSubmitDate': '2018-09-17', 'studyFirstSubmitQcDate': '2018-09-18', 'lastUpdatePostDateStruct': {'date': '2019-08-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'survival after thawing', 'timeFrame': '6 days of culture'}], 'secondaryOutcomes': [{'measure': 'fertilization rate', 'timeFrame': '6 days of culture'}, {'measure': 'Rates of blastocyst formation and quality', 'timeFrame': '6 days of culture', 'description': 'Number of formed blastocyst and blastocyst with high-quality per fertilized oocytes'}, {'measure': 'embryo utilisation rate', 'timeFrame': '6 days of culture'}, {'measure': 'clinical pregnancy rate', 'timeFrame': 'three months'}, {'measure': 'ongoing pregnancy rate', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Infertility']}, 'descriptionModule': {'briefSummary': 'Using the cytoskeleton Stabilizer the Cytochalasin B would improve the outcome of oocyte vitrification.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '42 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* indication for oocyte vitrification\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT03678558', 'briefTitle': 'Oocyte Vitrification Aided With Cytochalasin B', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Ibn Sina Hospital'}, 'officialTitle': 'Cytochalasin B for Oocyte Vitrification', 'orgStudyIdInfo': {'id': 'IbnSina-Oocyte-CB'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cytochalasin B supplemented vitrification medium', 'interventionNames': ['Other: Cytochalasin B supplemented vitrification medium']}, {'type': 'NO_INTERVENTION', 'label': 'Vitrification medium with no supplementation'}], 'interventions': [{'name': 'Cytochalasin B supplemented vitrification medium', 'type': 'OTHER', 'description': 'Vitrification of human oocyte in medium supplemented with Cytochalasin B', 'armGroupLabels': ['Cytochalasin B supplemented vitrification medium']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12345', 'city': 'Sohag', 'country': 'Egypt', 'facility': 'IbnSina IVF Center, IbnSina Hospital', 'geoPoint': {'lat': 26.55695, 'lon': 31.69478}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ibn Sina Hospital', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Banoon IVF Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'IVF Lab Director', 'investigatorFullName': 'Muhammad Fawzy', 'investigatorAffiliation': 'Ibn Sina Hospital'}}}}