Ignite Creation Date:
2025-12-24 @ 7:10 PM
Ignite Modification Date:
2026-02-25 @ 5:52 PM
Study NCT ID:
NCT03665103
Status:
COMPLETED
Last Update Posted:
2019-08-07
First Post:
2018-09-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Laser-assisted ICSI Versus Conventional ICSI
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': 966}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-09-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2019-08-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-05', 'studyFirstSubmitDate': '2018-09-06', 'studyFirstSubmitQcDate': '2018-09-07', 'lastUpdatePostDateStruct': {'date': '2019-08-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'oocyte survival after injection', 'timeFrame': '6 days of culture'}], 'secondaryOutcomes': [{'measure': 'blastocyst formation rate', 'timeFrame': '6 days of culture'}, {'measure': 'embryo utilization rate', 'timeFrame': '6 days of culture'}, {'measure': 'clinical pregnancy rate', 'timeFrame': 'four weeks after embryo transfer'}, {'measure': 'ongoing pregnancy rate', 'timeFrame': 'Twelve weeks of gestation'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Infertility']}, 'referencesModule': {'references': [{'pmid': '32995832', 'type': 'DERIVED', 'citation': 'Fawzy M, Emad M, Mahran A, Abdelrahman MY, Fetih AN, Abdelghafar H, Elsuity MA, Rashed H, Sabry M. A randomized controlled trial of laser-assisted ICSI. Hum Reprod. 2020 Dec 1;35(12):2692-2700. doi: 10.1093/humrep/deaa160.'}]}, 'descriptionModule': {'briefSummary': 'Degeneration rate after ICSI is expectable but decreasing it is a goal. Laser-assisted ICSI can serve to decrease this degeneration rate.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* all ICSI cycles\n\nExclusion Criteria:\n\n* no exclusion'}, 'identificationModule': {'nctId': 'NCT03665103', 'briefTitle': 'Laser-assisted ICSI Versus Conventional ICSI', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Ibn Sina Hospital'}, 'officialTitle': 'Laser-assisted ICSI Effect on Degeneration Rate After ICSI', 'orgStudyIdInfo': {'id': 'Laser-ICSI'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Laser-assisted ICSI', 'interventionNames': ['Other: Laser-assisted ICSI']}, {'type': 'NO_INTERVENTION', 'label': 'conventional ICSI'}], 'interventions': [{'name': 'Laser-assisted ICSI', 'type': 'OTHER', 'description': 'Laser opening of the zona pellucida.', 'armGroupLabels': ['Laser-assisted ICSI']}]}, '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'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'IVF Lab Director', 'investigatorFullName': 'Muhammad Fawzy', 'investigatorAffiliation': 'Ibn Sina Hospital'}}}}