Ignite Creation Date:
2025-12-25 @ 2:23 AM
Ignite Modification Date:
2026-02-25 @ 6:58 PM
Study NCT ID:
NCT03663634
Status:
COMPLETED
Last Update Posted:
2019-08-07
First Post:
2018-09-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Supplementing Intracytoplasmic Sperm Injection Handling Medium 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', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 987}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-09-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2019-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-05', 'studyFirstSubmitDate': '2018-09-06', 'studyFirstSubmitQcDate': '2018-09-06', 'lastUpdatePostDateStruct': {'date': '2019-08-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'oocyte survival rate', 'timeFrame': '6 days of culture', 'description': 'number of survived oocyte after intracytoplasmic sperm injection'}], 'secondaryOutcomes': [{'measure': 'fertilization rate', 'timeFrame': '6 days of culture', 'description': 'number of fertilized oocytes per metaphase II injected'}, {'measure': 'blastocyst formation rate', 'timeFrame': '6 days of culture', 'description': 'number of formed blastocyst per fertilized oocyte'}, {'measure': 'embryo utilization rate', 'timeFrame': '6 days of culture', 'description': 'number of embryo transferred added to number of those cryopreserved per fertilized oocyte'}, {'measure': 'clinical pregnancy rate', 'timeFrame': 'three months', 'description': 'number of women with a heartbeat at week 4 or more after embryo transfer'}, {'measure': 'ongoing pregnancy rate', 'timeFrame': 'four months', 'description': 'number of women with continued pregnancy after twelve weeks of gestation'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Infertility']}, 'descriptionModule': {'briefSummary': 'Vienna Consensus has identified 10% damage rate after ICSI as a competency value. Despite the highest quality embryologists doing ICSI, degeneration sometimes occurs due to oocyte factors such as the fragile membrane, etc. Cytochalasin B serves to facilitate spindle or pronuclear transfer procedures helping to reduce the damage rate with no harm reported. Using Cytochalasin B during ICSI could serve to rescue some oocytes from the degeneration allowing for more chances of viable zygotes,'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All ICSI candidates patients\n\nExclusion Criteria:\n\n* No exclusion'}, 'identificationModule': {'nctId': 'NCT03663634', 'acronym': 'ICSI-CB', 'briefTitle': 'Supplementing Intracytoplasmic Sperm Injection Handling Medium With Cytochalasin B', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Ibn Sina Hospital'}, 'officialTitle': 'Cytochalasin B Supplementation to ICSI Handling Medium', 'orgStudyIdInfo': {'id': 'IbnSinaIVF-ICSI-CB'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Handling Medium Supplemented with Cytochalasin B', 'interventionNames': ['Other: Cytochalasin B use in ICSI handling medium']}, {'type': 'NO_INTERVENTION', 'label': 'Handling Medium as it is.'}], 'interventions': [{'name': 'Cytochalasin B use in ICSI handling medium', 'type': 'OTHER', 'description': 'A medium with in-house supplementation of Cytochalasin B to decrease oocyte degeneration after ICSI and improve survival rate', 'armGroupLabels': ['Handling Medium Supplemented with Cytochalasin B']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sohag', 'country': 'Egypt', 'facility': 'IbnSina IVF Center', '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'}}}}