Ignite Creation Date:
2025-12-24 @ 9:50 PM
Ignite Modification Date:
2025-12-25 @ 7:28 PM
Study NCT ID:
NCT03548532
Status:
COMPLETED
Last Update Posted:
2024-09-19
First Post:
2017-10-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Embryo Culture At a Constant Temperature of 36.6°C or 37.1°C
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Based on the randomisation list, patients fulfilling the inclusion criteria will be assigned to one of each arm. A total of 119 patients are needed in every arm in this superiority trial.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 234}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2023-01-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-04', 'studyFirstSubmitDate': '2017-10-23', 'studyFirstSubmitQcDate': '2018-06-06', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical pregnancy', 'timeFrame': '7 weeks', 'description': 'ultrasound: sac and fetal heartbeat positive'}], 'secondaryOutcomes': [{'measure': 'Fertilization rate', 'timeFrame': '1 day', 'description': 'number of fertilized oocytes, per number of injected oocytes'}, {'measure': 'embryo development/utilization rate', 'timeFrame': '6 days', 'description': 'number of embryos transferred or cryopreserved per fertilized oocytes'}, {'measure': 'live birth rate of the fresh cycle', 'timeFrame': '43 weeks', 'description': 'number of live births per started cycle'}, {'measure': 'cumulative live birth rate per cycle', 'timeFrame': '104 weeks', 'description': 'fresh and frozen embryo transfer: outcome of the deliveries'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['temperature'], 'conditions': ['Temperature; Extreme, Exposure']}, 'referencesModule': {'references': [{'pmid': '39241807', 'type': 'DERIVED', 'citation': 'Wouters K, Mateizel I, Segers I, Van de Velde H, Van Landuyt L, De Vos A, Schoemans C, Jankovic D, Blockeel C, Drakopoulos P, Tournaye H, De Munck N. Clinical pregnancy rates after blastocyst culture at a stable temperature of 36.6 degrees C versus 37.1 degrees C: a prospective randomized controlled trial. Hum Reprod. 2024 Oct 1;39(10):2233-2239. doi: 10.1093/humrep/deae193.'}]}, 'descriptionModule': {'briefSummary': 'On the day of oocyte retrieval, participants will be randomized to stable culture at 37.1°C or 36.6°C with the ultimate aim of finding a difference in clincial pregnancies.', 'detailedDescription': 'A previous study in our centre analysed stable embryo culture at 36.6°C and 37.1°C, on sibling oocytes. The primary aim was to analyse possible differneces in embryo development (utilization rate) up to day 5/6. In this study, the investigators found a high difference in clinical pregnancy rate between both groups (46.4% versus 77.4%). Since this study was not powered to find differences in clincial pregnancy rates between both groups, this RCT was especially powered as a superiority trial to find differences in clincial pregnancy rates between both groups. On the day of oocyte retrieval, patients will be allocated to culture at one of both temperatures.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Day 5 transfer\n* Single embryo transfer\n* Only ejaculated sperm (fresh or frozen, autologous or heterologous)\n* BMI \\<35\n* Age \\<40 years\n* Cycle rank \\<3 for the current child\n* Last ultrasound: 8 follicles of at least 12 mm\n* At least 6 mature oocytes\n\nExclusion Criteria:\n\n* IVF\n* IVF versus ICSI\n* Failed fertilization in previous cycle\n* no previous cycle without embryo transfer\n* No use of Ca ionophores for embryo quality or fertilization problems'}, 'identificationModule': {'nctId': 'NCT03548532', 'briefTitle': 'Embryo Culture At a Constant Temperature of 36.6°C or 37.1°C', 'organization': {'class': 'OTHER', 'fullName': 'Universitair Ziekenhuis Brussel'}, 'officialTitle': 'Embryo Culture At a Constant Temperature of 36.6°C or 37.1°C: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '2017/060'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '36.6°C', 'description': 'Embryos of these patients will be cultured at 36.6°C from day 0 after ICSI, untill day 6.', 'interventionNames': ['Device: G210 incubator']}, {'type': 'EXPERIMENTAL', 'label': '37.1°C', 'description': 'Embryos of these patients will be cultured at 37.1°C from day 0 after ICSI, untill day 6.', 'interventionNames': ['Device: G210 incubator']}], 'interventions': [{'name': 'G210 incubator', 'type': 'DEVICE', 'otherNames': ['Ksystems'], 'description': 'very stable culture temperature, up to 0.1°C, in both arms', 'armGroupLabels': ['36.6°C', '37.1°C']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1090', 'city': 'Brussels', 'state': 'Brussels Capital', 'country': 'Belgium', 'facility': 'Universitair Ziekenhuis Brussel', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}], 'overallOfficials': [{'name': 'Greta Verheyen, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'UZBrussel'}]}, 'ipdSharingStatementModule': {'url': 'http://www.brusselsivf.be', 'infoTypes': ['SAP'], 'timeFrame': 'within 6 months after study completion', 'ipdSharing': 'YES', 'description': 'For statistical Analysis', 'accessCriteria': 'Only relevant information will be given to the statistician (who is also a clinical doctor in our centre)'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitair Ziekenhuis Brussel', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD', 'investigatorFullName': 'Neelke De Munck', 'investigatorAffiliation': 'Universitair Ziekenhuis Brussel'}}}}