Ignite Creation Date:
2025-12-24 @ 4:40 PM
Ignite Modification Date:
2025-12-24 @ 4:40 PM
Study NCT ID:
NCT03778866
Status:
COMPLETED
Last Update Posted:
2019-08-07
First Post:
2018-12-15
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparing HEPES-buffered With Bicarbonate-buffered as Handling Media During the ICSI Procedure on Live Birth Rate
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': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1057}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2019-08-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-05', 'studyFirstSubmitDate': '2018-12-15', 'studyFirstSubmitQcDate': '2018-12-17', 'lastUpdatePostDateStruct': {'date': '2019-08-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'live birth rate', 'timeFrame': '40 weeks', 'description': 'viable neonate after 30 weeks of Gestation'}], 'secondaryOutcomes': [{'measure': 'Clinical pregnancy rate', 'timeFrame': '12 weeks', 'description': 'a positive heartbeat on ultrasound at ≥ 7 weeks of gestation'}, {'measure': 'biochemical pregnancy rate', 'timeFrame': 'two weeks', 'description': 'positive b-hCG at ≥ 14 days following embryo transfer'}, {'measure': 'embryo developmental rates', 'timeFrame': '6 days of culture', 'description': 'fertilized oocyte per injected ones and developed embryos per fertilized oocytes'}, {'measure': 'Ongoing pregnancy rate', 'timeFrame': '16 weeks', 'description': 'Continued pregnancy after week 12 of gestation'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Infertility']}, 'descriptionModule': {'briefSummary': 'The pH stability during human gamete handling for intracytoplasmic sperm injection (ICSI) is physiologically sound. As the pH change for bicarbonate-buffered medium, scientists assumed whether the use of HEPES or MOPS buffered medium would provide more stable pH, thereby better outcomes. However, the oil use and time frame outside the incubators have not been accounted for. This study is to evaluate the use of HEPES buffered medium compared with the bicarbonate-buffered medium on ICSI outcomes.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ICSI indicated cycles\n\nExclusion Criteria:\n\n* severe medical illness'}, 'identificationModule': {'nctId': 'NCT03778866', 'briefTitle': 'Comparing HEPES-buffered With Bicarbonate-buffered as Handling Media During the ICSI Procedure on Live Birth Rate', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Ibn Sina Hospital'}, 'officialTitle': 'Whether the Use of HEPES-buffered Medium Would Affect Live Birth Rate After ICSI', 'orgStudyIdInfo': {'id': 'IbnSina-HEPES'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Bicarbonate-buffered Medium', 'interventionNames': ['Other: Bicarbonate-buffered handling medium']}, {'type': 'NO_INTERVENTION', 'label': 'HEPES-MOPS-buffered Medium'}], 'interventions': [{'name': 'Bicarbonate-buffered handling medium', 'type': 'OTHER', 'description': 'The investigators will evaluate whether the usual bicarbonate culture medium can replace the HEPES buffered medium effectively.', 'armGroupLabels': ['Bicarbonate-buffered Medium']}]}, 'contactsLocationsModule': {'locations': [{'zip': '123456', 'city': 'Qina', 'state': 'Qena Governorate', 'country': 'Egypt', 'facility': 'Qena Fertility Center', 'geoPoint': {'lat': 26.16418, 'lon': 32.72671}}, {'city': 'Asyut', 'country': 'Egypt', 'facility': 'Banon Assiut', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}, {'city': 'Sohag', 'country': 'Egypt', 'facility': 'IbnSina IVF Center', 'geoPoint': {'lat': 26.55695, 'lon': 31.69478}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Muhammad Fawzy', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Banoon IVF Center', 'class': 'OTHER'}, {'name': 'Quena IVF Center', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'IVF Lab Director', 'investigatorFullName': 'Muhammad Fawzy', 'investigatorAffiliation': 'Ibn Sina Hospital'}}}}