Ignite Creation Date:
2025-12-24 @ 4:50 PM
Ignite Modification Date:
2026-01-06 @ 4:17 PM
Study NCT ID:
NCT03522350
Status:
TERMINATED
Last Update Posted:
2019-05-31
First Post:
2018-02-20
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Randomized Trial Comparing EmbryoScope With EmbryoScope+.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007246', 'term': 'Infertility'}], 'ancestors': [{'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020669', 'term': 'Fetoscopes'}], 'ancestors': [{'id': 'D019723', 'term': 'Endoscopes'}, {'id': 'D019719', 'term': 'Diagnostic Equipment'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D013523', 'term': 'Surgical Equipment'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'nizanin@med.cornell.edu', 'phone': '212-746-5790', 'title': 'Nikica Zaninovic, PhD', 'organization': 'Weill Cornell Medical College'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '3 months', 'eventGroups': [{'id': 'EG000', 'title': 'All Participants Enrolled', 'description': 'All participants enrolled and randomized to Embryoscope and Embryoscope+', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 0, 'seriousNumAtRisk': 18, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Day 3 Embryos', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}, {'units': 'embryos', 'counts': [{'value': '115', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Embryoscope +', 'description': 'Embryoscope +'}, {'id': 'OG001', 'title': 'Embryoscope', 'description': 'Embryoscope'}], 'classes': [{'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'Day 3 post retrieval', 'description': 'Comparing number of embryos that fertilized normally and had development at Day 3 based on embryo grade between oocytes assigned to Standard EmbryoScope versus oocytes assigned to EmbryoScope+', 'unitOfMeasure': 'embryos', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'embryos', 'denomUnitsSelected': 'embryos', 'populationDescription': 'Number of day 3 embryos compared in both groups'}, {'type': 'PRIMARY', 'title': 'Number of Day 5 Embryos', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}, {'units': 'embryos', 'counts': [{'value': '115', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Embryoscope +', 'description': 'Embryoscope +'}, {'id': 'OG001', 'title': 'Embryoscope', 'description': 'Embryoscope'}], 'classes': [{'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'Day 5 post retrieval', 'description': 'Comparing the number pf embryos that developed at Day 5 based on embryo grade between oocytes assigned to Standard EmbryoScope versus oocytes assigned to EmbryoScope+', 'unitOfMeasure': 'embryos', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'embryos', 'denomUnitsSelected': 'embryos'}, {'type': 'SECONDARY', 'title': 'Implantation Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Embryoscope +', 'description': 'Embryoscope +'}, {'id': 'OG001', 'title': 'Embryoscope', 'description': 'Embryoscope'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '5-6 weeks post retrieval', 'description': 'Presence of a gestational sac', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Pregnancy Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Embryoscope +', 'description': 'Embryoscope +'}, {'id': 'OG001', 'title': 'Embryoscope', 'description': 'Embryoscope'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2 weeks post retrieval', 'description': 'Positive Bhcg', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Embryoscope +', 'description': 'Embryoscope +'}, {'id': 'FG001', 'title': 'Embryoscope', 'description': 'Embryoscope'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '115', 'numSubjects': '18'}, {'groupId': 'FG001', 'numUnits': '116', 'numSubjects': '18'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '115', 'numSubjects': '18'}, {'groupId': 'FG001', 'numUnits': '116', 'numSubjects': '18'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '0'}]}]}], 'typeUnitsAnalyzed': 'Oocytes', 'recruitmentDetails': 'Patients undergoing IVF were be recruited to participate in the study. Those agreeing to participate consented to have their embryos incubated in the new Embryoscope+ as opposed to the current one being used as standard of care.', 'preAssignmentDetails': '18 subjects will undergo IVF. Participant\'s oocytes at retrieval will be randomly assigned to both groups for comparison: Standard EmbryoScope system versus EmbryoScope+. The best quality embryos are selected for embryo transfer and the pregnancy outcome is evaluated. "Best grade" embryos will be transferred regardless of EmbryoScope use.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Study Participants', 'description': 'This includes all participants - oocytes were randomized to standard of care embryo incubator and experimental Embryoscope +'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '18', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '33.6', 'groupId': 'BG000', 'lowerLimit': '26', 'upperLimit': '39'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '18', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '17', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-05-17', 'size': 113120, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-05-06T07:06', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'whyStopped': 'Device has been FDA approved.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-09-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2018-06-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-06', 'studyFirstSubmitDate': '2018-02-20', 'resultsFirstSubmitDate': '2019-05-06', 'studyFirstSubmitQcDate': '2018-05-09', 'lastUpdatePostDateStruct': {'date': '2019-05-31', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-05-06', 'studyFirstPostDateStruct': {'date': '2018-05-11', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2019-05-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Day 3 Embryos', 'timeFrame': 'Day 3 post retrieval', 'description': 'Comparing number of embryos that fertilized normally and had development at Day 3 based on embryo grade between oocytes assigned to Standard EmbryoScope versus oocytes assigned to EmbryoScope+'}, {'measure': 'Number of Day 5 Embryos', 'timeFrame': 'Day 5 post retrieval', 'description': 'Comparing the number pf embryos that developed at Day 5 based on embryo grade between oocytes assigned to Standard EmbryoScope versus oocytes assigned to EmbryoScope+'}], 'secondaryOutcomes': [{'measure': 'Implantation Rate', 'timeFrame': '5-6 weeks post retrieval', 'description': 'Presence of a gestational sac'}, {'measure': 'Pregnancy Rate', 'timeFrame': '2 weeks post retrieval', 'description': 'Positive Bhcg'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Infertility', 'Embryo develpoment', 'IVF', 'ICSI', 'EmbryoScope'], 'conditions': ['Infertility']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to compare the current EmbryoScope Time-Lapse System being used in IVF which has become standard of care to the new model EmbryoScope to demonstrate that the EmbryoScope+ is as safe and reliable as the EmbryoScope.', 'detailedDescription': 'This is a randomized, controlled, single-center study in otherwise healthy infertile female subjects undergoing in vitro fertilization (IVF). The subjects recruited for this study will be among those patients who have been diagnosed with infertility and are planning to undergo IVF at the center where this study is being performed. The subjects will have undergone the usual informed consent procedure at the center.\n\nSubjects will undergo ovarian stimulation, oocyte retrieval, IVF, and Intra Cytoplasmic Sperm Injection (ICSI) procedure following the center\'s usual procedures. At the time of retrieval, participant\'s oocytes will be randomly assigned to both groups for comparison: Standard EmbryoScope Time-Lapse system versus EmbryoScope+. The best quality embryos are selected for embryo transfer and the pregnancy outcome is evaluated.\n\n"Best grade" embryos will be transferred regardless of EmbryoScope use. The standard EmbryoScope as well as the EmbryoScope+ monitor system as assigned during the randomization process will be used to observe the embryo development and document timing of embryo cleavages and morphology dynamics. Subjects will not be provided with the time- lapse images.\n\nEndpoints will be Day 3 and Day 5/6 embryo development, implantation and pregnancy rate. The study is approximately 2 months, the estimated time it takes a physician to perform one IVF-ART treatment cycle. If embryos are frozen, the patient may be in the study until the time they choose to thaw the embryos or up to 1 year if they become pregnant.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Maternal age- 40 years of age or younger Paternal age- 65 years of age or younger', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 40 years of age or younger (maternal)\n* 65 years of age or younger (paternal)\n* Fresh or frozen (including donor) sperm can be used\n* Fresh oocytes only (including donor)\n* Frozen embryos from this study can be included in the outcome portion of this study.\n* Single or double Blastocyst transfer only\n\nExclusion Criteria:\n\n* 3 or more previous failed cycles\n* Sperm obtained by testicular biopsy\n* Co-culture patients'}, 'identificationModule': {'nctId': 'NCT03522350', 'briefTitle': 'Randomized Trial Comparing EmbryoScope With EmbryoScope+.', 'organization': {'class': 'OTHER', 'fullName': 'Weill Medical College of Cornell University'}, 'officialTitle': 'Randomized Controlled Trial Comparing EmbryoScope Time-Lapse System With the New Model EmbryoScope+.', 'orgStudyIdInfo': {'id': '1612017837'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'EmbryoScope', 'description': 'Standard of care embryo incubator.', 'interventionNames': ['Device: EmbryoScope']}, {'type': 'EXPERIMENTAL', 'label': 'EmbryoScope+', 'description': 'New experimental embryo incubator.', 'interventionNames': ['Device: EmbryoScope+']}], 'interventions': [{'name': 'EmbryoScope', 'type': 'DEVICE', 'description': 'Standard of care arm', 'armGroupLabels': ['EmbryoScope']}, {'name': 'EmbryoScope+', 'type': 'DEVICE', 'description': 'Experimental arm', 'armGroupLabels': ['EmbryoScope+']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Center for Reproductive Medicine', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Nikica Zaninovic, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Center for Reproductive Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Weill Medical College of Cornell University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Vitrolife', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}