Ignite Creation Date:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2026-02-22 @ 10:36 PM
Study NCT ID:
NCT02852356
Status:
COMPLETED
Last Update Posted:
2024-05-24
First Post:
2016-07-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Validation Study Using a Time-lapse Morphometry MIRI Imaging Incubator
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'tex@ovationfertility.com', 'phone': '5126107474', 'title': 'Director', 'organization': 'Ovation Fertility'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '9 months', 'description': 'No adverse events were reported in this study. All-Cause Mortality was not monitored/assessed.', 'eventGroups': [{'id': 'EG000', 'title': 'Control Incubator', 'description': 'Standard Incubator', 'otherNumAtRisk': 31, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 31, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'MIRI-TL Timelapse Incubator', 'description': 'Timelapse incubator\n\nMIRI-TL Incubator: MIRI-TL Timelapse incubator', 'otherNumAtRisk': 31, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 31, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Culture Coin Dish', 'description': 'Culture Coin dish for embryo culture\n\nMIRI-TL Incubator: MIRI-TL Timelapse incubator', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Control Dish', 'description': 'Control Dish for embryo culture', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With a Positive bHCG Level as Detected by a Blood Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Incubator', 'description': 'Standard Incubator'}, {'id': 'OG001', 'title': 'MIRI-TL Timelapse Incubator', 'description': 'Timelapse incubator\n\nMIRI-TL Incubator: MIRI-TL Timelapse incubator'}, {'id': 'OG002', 'title': 'Culture Coin Dish', 'description': 'Culture Coin dish for embryo culture\n\nMIRI-TL Incubator: MIRI-TL Timelapse incubator'}, {'id': 'OG003', 'title': 'Control Dish', 'description': 'Control Dish for embryo culture'}], 'classes': [{'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '14 days after embryo transfer', 'description': 'Human Chorionic Gonadotropin (hormone made by cells formed in the placenta) are detected by a blood test. An hCG level \\>50mIU/mL is considered to be a successful pregnancy.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'number in incubator equals number in dish'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Embryo Implantation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Incubator', 'description': 'Standard Incubator'}, {'id': 'OG001', 'title': 'MIRI-TL Timelapse Incubator', 'description': 'Timelapse incubator\n\nMIRI-TL Incubator: MIRI-TL Timelapse incubator'}, {'id': 'OG002', 'title': 'Culture Coin Dish', 'description': 'Culture Coin dish for embryo culture\n\nMIRI-TL Incubator: MIRI-TL Timelapse incubator'}, {'id': 'OG003', 'title': 'Control Dish', 'description': 'Control Dish for embryo culture'}], 'classes': [{'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '28 days', 'description': 'Presence of Gestational Sac by ultrasound indicates a positive pregnancy.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'number in incubator equals number in dish'}, {'type': 'SECONDARY', 'title': 'Embryo Development', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'units': 'Embryos', 'counts': [{'value': '150', 'groupId': 'OG000'}, {'value': '165', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Incubator', 'description': 'Standard Incubator'}, {'id': 'OG001', 'title': 'MIRI-TL Timelapse Incubator', 'description': 'Timelapse incubator\n\nMIRI-TL Incubator: MIRI-TL Timelapse incubator'}, {'id': 'OG002', 'title': 'Culture Coin Dish', 'description': 'Culture Coin dish for embryo culture\n\nMIRI-TL Incubator: MIRI-TL Timelapse incubator'}, {'id': 'OG003', 'title': 'Control Dish', 'description': 'Control Dish for embryo culture'}], 'classes': [{'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': '7 days', 'description': 'Blastocyst Utilisation Rate (number of fertilised embryos which develop to usable blastocysts)', 'unitOfMeasure': 'Embryos', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Embryos', 'denomUnitsSelected': 'Embryos', 'populationDescription': 'number in incubator equals number in dish'}, {'type': 'POST_HOC', 'title': 'Number of Patients With Live Birth', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Incubator', 'description': 'Standard Incubator'}, {'id': 'OG001', 'title': 'MIRI-TL Timelapse Incubator', 'description': 'Timelapse incubator\n\nMIRI-TL Incubator: MIRI-TL Timelapse incubator'}, {'id': 'OG002', 'title': 'Culture Coin Dish', 'description': 'Culture Coin dish for embryo culture\n\nMIRI-TL Incubator: MIRI-TL Timelapse incubator'}, {'id': 'OG003', 'title': 'Control Dish', 'description': 'Control Dish for embryo culture'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '9 months', 'description': 'Reported live birth of a child', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'No participants in the culture coin Dish or the control dish.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Control Incubator', 'description': 'Standard Incubator'}, {'id': 'FG001', 'title': 'MIRI-TL Timelapse Incubator', 'description': 'Timelapse incubator\n\nMIRI-TL Incubator: MIRI-TL Timelapse incubator'}, {'id': 'FG002', 'title': 'Culture Coin Dish', 'description': 'Culture Coin dish for embryo culture\n\nMIRI-TL Incubator: MIRI-TL Timelapse incubator'}, {'id': 'FG003', 'title': 'Control Dish', 'description': 'Control Dish for embryo culture'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '31'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '31'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '62', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Control Incubator', 'description': 'Standard Incubator'}, {'id': 'BG001', 'title': 'MIRI-TL Timelapse Incubator', 'description': 'Timelapse incubator\n\nMIRI-TL Incubator: MIRI-TL Timelapse incubator'}, {'id': 'BG002', 'title': 'Culture Coin Dish', 'description': 'Culture Coin dish for embryo culture\n\nMIRI-TL Incubator: MIRI-TL Timelapse incubator'}, {'id': 'BG003', 'title': 'Control Dish', 'description': 'Control Dish for embryo culture'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '62', 'groupId': 'BG004'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG004'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '62', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}], 'populationDescription': 'patients in the dishes equal number in incubator'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-06-15', 'size': 284953, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-11-17T12:25', 'hasProtocol': True}, {'date': '2016-06-15', 'size': 202209, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2022-11-17T12:26', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 62}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2017-12-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-29', 'studyFirstSubmitDate': '2016-07-28', 'resultsFirstSubmitDate': '2022-09-29', 'studyFirstSubmitQcDate': '2016-07-28', 'lastUpdatePostDateStruct': {'date': '2024-05-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-04-29', 'studyFirstPostDateStruct': {'date': '2016-08-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2024-05-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With a Positive bHCG Level as Detected by a Blood Test', 'timeFrame': '14 days after embryo transfer', 'description': 'Human Chorionic Gonadotropin (hormone made by cells formed in the placenta) are detected by a blood test. An hCG level \\>50mIU/mL is considered to be a successful pregnancy.'}], 'secondaryOutcomes': [{'measure': 'Number of Patients With Embryo Implantation', 'timeFrame': '28 days', 'description': 'Presence of Gestational Sac by ultrasound indicates a positive pregnancy.'}, {'measure': 'Embryo Development', 'timeFrame': '7 days', 'description': 'Blastocyst Utilisation Rate (number of fertilised embryos which develop to usable blastocysts)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Fertility']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety and efficacy of the MIRI-TL time-lapse incubator and CultureCoin dish compared to standard big-box incubators and standard culture dishes used for embryo culture.', 'detailedDescription': 'Following randomization and standard ovarian stimulation protocols to obtain a sufficient number of mature (MII) oocytes, these oocytes will be fertilized by Intra-Cytoplasmic Sperm Injection (ICSI). If a patient has been randomized to the study group, all inseminated oocytes and subsequently all fertilized diploid (2PN) zygotes will be placed in the CultureCoin and then into the MIRI-TL Time-lapse incubator and cultured as per normal protocol to the blastocyst stage (Day 5/6 or 7). Top quality blastocyst(s) will be transferred and monitored for implantation, pregnancy and ongoing birth. Embryo transfers will either occur in a fresh or frozen embryo transfer cycle.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* At least 18 years of age\n* Women undergoing in vitro fertilization treatment using their own or frozen oocytes\n* Fresh or Frozen Embryo Transfer\n* Fertilization by ICSI\n* At least 4 diploid (2PN) embryos at fertilization check\n* Willing to have all inseminated oocytes imaged by Miri\n* Willing to comply with study protocol and procedures Willing to provide written informed consent\n\nExclusion Criteria:\n\n* Fertilization using surgically removed sperm\n* History of cancer'}, 'identificationModule': {'nctId': 'NCT02852356', 'acronym': 'TiMMI', 'briefTitle': 'Validation Study Using a Time-lapse Morphometry MIRI Imaging Incubator', 'organization': {'class': 'OTHER', 'fullName': 'Ovation Fertility'}, 'officialTitle': 'Prospective Observational and Validation Study Using Time-lapse Morphometry MIRI Imaging Incubator (TiMMI Study)', 'orgStudyIdInfo': {'id': '2016-TiMMI-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control Incubator', 'description': 'Standard Incubator'}, {'type': 'EXPERIMENTAL', 'label': 'MIRI-TL Timelapse Incubator', 'description': 'Timelapse incubator', 'interventionNames': ['Device: MIRI-TL Incubator']}, {'type': 'EXPERIMENTAL', 'label': 'Culture Coin Dish', 'description': 'Culture Coin dish for embryo culture', 'interventionNames': ['Device: MIRI-TL Incubator']}, {'type': 'NO_INTERVENTION', 'label': 'Control dish', 'description': 'Control Dish for embryo culture'}], 'interventions': [{'name': 'MIRI-TL Incubator', 'type': 'DEVICE', 'description': 'MIRI-TL Timelapse incubator', 'armGroupLabels': ['Culture Coin Dish', 'MIRI-TL Timelapse Incubator']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78731', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Ovation Fertility', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}], 'overallOfficials': [{'name': 'Matthew VerMilyea, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ovation Fertility'}]}, 'ipdSharingStatementModule': {'timeFrame': 'Project has ceased', 'ipdSharing': 'YES', 'description': 'Non-identified data regarding embryo development and pregnancy outcomes may be shared and discussed through presentations and publications.', 'accessCriteria': 'Project has ceased'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ovation Fertility', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}