Ignite Creation Date:
2025-12-24 @ 11:50 PM
Ignite Modification Date:
2026-01-07 @ 5:41 AM
Study NCT ID:
NCT03164551
Status:
TERMINATED
Last Update Posted:
2020-12-02
First Post:
2017-05-22
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
TICON-Day 3, Time Lapse Versus Conventional Method in Day 3 Embryo Culture and Assessment
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Germany', 'United Kingdom']}, 'conditionBrowseModule': {'meshes': [{'id': 'D007246', 'term': 'Infertility'}], 'ancestors': [{'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'service@emdgroup.com', 'phone': '+49-6151-72-5200', 'title': 'Communication Center', 'organization': 'Merck KGaA, Darmstadt, Germany'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Not Applicable (NA)', 'description': 'This is a fertility device technology study and this study was not designed to monitor all-cause mortality, serious, and other (not Including serious) adverse events. Therefore, all-cause mortality, serious, and other (not Including serious) adverse events data could not be reported.', 'eventGroups': [{'id': 'EG000', 'title': 'GERI+ Incubator', 'description': 'The embryo culture of consented participants carried out in Genea Embryo Review Instrument Plus (GERI+) incubator for both bright-field and dark-field time lapse monitoring until Day 3 of embryo culture. On Day 3, all embryos were reviewed firstly by GERI Assess software, using bright-field imaging. Finally the embryo(s) with the highest EEVA grade were transferred and were followed up until the achievement of implantation and confirmation of pregnancy.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Conventional Incubator', 'description': 'The embryo culture of consented participants were carried out in conventional incubator for culture until Day 3 of embryo culture. On Day 3 of embryo culture, all embryos were assessed using a bench-top microscope. The embryo(s) with optimal cell stage and grade were transferred and were followed up until the achievement of implantation and confirmation of pregnancy.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Clinical Pregnancy Rate With Positive Fetal Heart Beat (FHB)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'OG000'}, {'value': '208', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GERI+ Incubator', 'description': 'The embryo culture of consented participants carried out in Genea Embryo Review Instrument Plus (GERI+) incubator for both bright-field and dark-field time lapse monitoring until Day 3 of embryo culture. On Day 3, all embryos were reviewed firstly by GERI Assess software, using bright-field imaging. Finally the embryo(s) with the highest EEVA grade were transferred and were followed up until the achievement of implantation and confirmation of pregnancy.'}, {'id': 'OG001', 'title': 'Conventional Incubator', 'description': 'The embryo culture of consented participants were carried out in conventional incubator for culture until Day 3 of embryo culture. On Day 3 of embryo culture, all embryos were assessed using a bench-top microscope. The embryo(s) with optimal cell stage and grade were transferred and were followed up until the achievement of implantation and confirmation of pregnancy.'}], 'classes': [{'categories': [{'measurements': [{'value': '39.4', 'groupId': 'OG000'}, {'value': '38.9', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Gestation Weeks 6 to 8', 'description': 'Clinical Pregnancy was defined as the pregnancy diagnosed by ultrasonographic or clinical documentation of at least one fetus with heart beat in gestational week 6 to 8. Clinical pregnancy rate with positive FHB was measured as the number of participants with FHB positive clinical pregnancy divided by number of participants with embryo transfer (ET) multiplied by 100. Here, data used for analysis was based on Merck Global Medical Affairs (GMA) interpretation.', 'unitOfMeasure': 'Percentage of pregnancy per ET', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis (FA) dataset included all randomized participants.'}, {'type': 'SECONDARY', 'title': 'Utilizable Embryos Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '198', 'groupId': 'OG000'}, {'value': '208', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GERI+ Incubator', 'description': 'The embryo culture of consented participants carried out in Genea Embryo Review Instrument Plus (GERI+) incubator for both bright-field and dark-field time lapse monitoring until Day 3 of embryo culture. On Day 3, all embryos were reviewed firstly by GERI Assess software, using bright-field imaging. Finally the embryo(s) with the highest EEVA grade were transferred and were followed up until the achievement of implantation and confirmation of pregnancy.'}, {'id': 'OG001', 'title': 'Conventional Incubator', 'description': 'The embryo culture of consented participants were carried out in conventional incubator for culture until Day 3 of embryo culture. On Day 3 of embryo culture, all embryos were assessed using a bench-top microscope. The embryo(s) with optimal cell stage and grade were transferred and were followed up until the achievement of implantation and confirmation of pregnancy.'}], 'classes': [{'categories': [{'measurements': [{'value': '50.72', 'spread': '23.379', 'groupId': 'OG000'}, {'value': '50.11', 'spread': '24.183', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 3 of embryo culture', 'description': 'Utilizable embryos rate is defined as the number of transferred and cryopreserved embryos divided by the number embryos stage zygotes per participant multiply by 100. Here, data used for analysis was based on Merck GMA interpretation.', 'unitOfMeasure': 'Percentage of embryos', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FA dataset included all randomized participants. Here, "Number of participants analyzed" signifies participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Good Quality Embryos Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '198', 'groupId': 'OG000'}, {'value': '208', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GERI+ Incubator', 'description': 'The embryo culture of consented participants carried out in Genea Embryo Review Instrument Plus (GERI+) incubator for both bright-field and dark-field time lapse monitoring until Day 3 of embryo culture. On Day 3, all embryos were reviewed firstly by GERI Assess software, using bright-field imaging. Finally the embryo(s) with the highest EEVA grade were transferred and were followed up until the achievement of implantation and confirmation of pregnancy.'}, {'id': 'OG001', 'title': 'Conventional Incubator', 'description': 'The embryo culture of consented participants were carried out in conventional incubator for culture until Day 3 of embryo culture. On Day 3 of embryo culture, all embryos were assessed using a bench-top microscope. The embryo(s) with optimal cell stage and grade were transferred and were followed up until the achievement of implantation and confirmation of pregnancy.'}], 'classes': [{'categories': [{'measurements': [{'value': '34.85', 'spread': '25.999', 'groupId': 'OG000'}, {'value': '37.68', 'spread': '29.115', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 3 of embryo culture', 'description': 'Good Quality Embryos is defined embryos with 7 or more blastomeres, less than (\\<) 25 % fragmentation, size and symmetry of blastomeres appropriate to the cell number, and no evidence of multinucleation, based on the morphology on Day 3 of embryo culture. Good quality embryos rate was defined as the number of good quality embryos divided by the number of embryos per participant multiplied by 100. Here, data used for analysis was based on Merck GMA interpretation.', 'unitOfMeasure': 'Percentage of Good Quality Embryos', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FA dataset included all randomized participants. Here, "Number of participants analyzed" signifies participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Non-viable Embryos Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '198', 'groupId': 'OG000'}, {'value': '208', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GERI+ Incubator', 'description': 'The embryo culture of consented participants carried out in Genea Embryo Review Instrument Plus (GERI+) incubator for both bright-field and dark-field time lapse monitoring until Day 3 of embryo culture. On Day 3, all embryos were reviewed firstly by GERI Assess software, using bright-field imaging. Finally the embryo(s) with the highest EEVA grade were transferred and were followed up until the achievement of implantation and confirmation of pregnancy.'}, {'id': 'OG001', 'title': 'Conventional Incubator', 'description': 'The embryo culture of consented participants were carried out in conventional incubator for culture until Day 3 of embryo culture. On Day 3 of embryo culture, all embryos were assessed using a bench-top microscope. The embryo(s) with optimal cell stage and grade were transferred and were followed up until the achievement of implantation and confirmation of pregnancy.'}], 'classes': [{'categories': [{'measurements': [{'value': '29.64', 'spread': '27.932', 'groupId': 'OG000'}, {'value': '30.67', 'spread': '29.001', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Days 1 to 3 of embryo culture', 'description': 'Non-viable Embryos is defined as the embryos in which development has been arrested for at least 24 hour or in which all the cells have degenerated or lysed. Non-viable embryos rate was defined as the number of non-viable embryos divided by the number of embryos per participant multiplied by 100. Here, data used for analysis was based on Merck GMA interpretation.', 'unitOfMeasure': 'Percentage of Non-viable Embryos', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FA dataset included all randomized participants. Here, "Number of participants analyzed" signifies participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Implantation Rate (IR) With Positive Fetal Heart Beat', 'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'OG000'}, {'value': '208', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GERI+ Incubator', 'description': 'The embryo culture of consented participants carried out in Genea Embryo Review Instrument Plus (GERI+) incubator for both bright-field and dark-field time lapse monitoring until Day 3 of embryo culture. On Day 3, all embryos were reviewed firstly by GERI Assess software, using bright-field imaging. Finally the embryo(s) with the highest EEVA grade were transferred and were followed up until the achievement of implantation and confirmation of pregnancy.'}, {'id': 'OG001', 'title': 'Conventional Incubator', 'description': 'The embryo culture of consented participants were carried out in conventional incubator for culture until Day 3 of embryo culture. On Day 3 of embryo culture, all embryos were assessed using a bench-top microscope. The embryo(s) with optimal cell stage and grade were transferred and were followed up until the achievement of implantation and confirmation of pregnancy.'}], 'classes': [{'categories': [{'measurements': [{'value': '31.2', 'groupId': 'OG000'}, {'value': '32.5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Gestational Weeks 6 to 8', 'description': 'A successful implantation is defined as the presence of one gestational sac with fetal heart beat (FHB) under ultrasonography at gestational weeks 6-8. Implantation rate (IR) was defined as the number of intrauterine gestational sacs with positive FHB under ultrasound scans at gestational weeks 6-8 divided by the total number of embryos transferred (ET) multiplied by 100. Here, data used for analysis was based on Merck GMA interpretation.', 'unitOfMeasure': 'Percentage of gestational sacs per ET', 'reportingStatus': 'POSTED', 'populationDescription': 'FA dataset included all randomized participants.'}, {'type': 'SECONDARY', 'title': 'Biochemical Pregnancy Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'OG000'}, {'value': '208', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GERI+ Incubator', 'description': 'The embryo culture of consented participants carried out in Genea Embryo Review Instrument Plus (GERI+) incubator for both bright-field and dark-field time lapse monitoring until Day 3 of embryo culture. On Day 3, all embryos were reviewed firstly by GERI Assess software, using bright-field imaging. Finally the embryo(s) with the highest EEVA grade were transferred and were followed up until the achievement of implantation and confirmation of pregnancy.'}, {'id': 'OG001', 'title': 'Conventional Incubator', 'description': 'The embryo culture of consented participants were carried out in conventional incubator for culture until Day 3 of embryo culture. On Day 3 of embryo culture, all embryos were assessed using a bench-top microscope. The embryo(s) with optimal cell stage and grade were transferred and were followed up until the achievement of implantation and confirmation of pregnancy.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.2', 'groupId': 'OG000'}, {'value': '4.7', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Day 12 of Gestational up to Week 8', 'description': 'Biochemical Pregnancy defined as a pregnancy diagnosed only by the detection of Human Chorionic Gonadotropin (hCG) in serum or urine and that does not develop into a clinical pregnancy. Biochemical pregnancy rate was defined as the number of participants with biochemical pregnancy divided by the number of participants with embryo transfer (ET) multiplied by 100. Here, data used for analysis was based on Merck GMA interpretation.', 'unitOfMeasure': 'Percentage of Pregnancy per ET', 'reportingStatus': 'POSTED', 'populationDescription': 'FA dataset included all randomized participants.'}, {'type': 'SECONDARY', 'title': 'Ongoing Pregnancy Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'OG000'}, {'value': '208', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GERI+ Incubator', 'description': 'The embryo culture of consented participants carried out in Genea Embryo Review Instrument Plus (GERI+) incubator for both bright-field and dark-field time lapse monitoring until Day 3 of embryo culture. On Day 3, all embryos were reviewed firstly by GERI Assess software, using bright-field imaging. Finally the embryo(s) with the highest EEVA grade were transferred and were followed up until the achievement of implantation and confirmation of pregnancy.'}, {'id': 'OG001', 'title': 'Conventional Incubator', 'description': 'The embryo culture of consented participants were carried out in conventional incubator for culture until Day 3 of embryo culture. On Day 3 of embryo culture, all embryos were assessed using a bench-top microscope. The embryo(s) with optimal cell stage and grade were transferred and were followed up until the achievement of implantation and confirmation of pregnancy.'}], 'classes': [{'categories': [{'measurements': [{'value': '35.0', 'groupId': 'OG000'}, {'value': '36.3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Gestational Weeks 10 to 12', 'description': 'Ongoing pregnancy is defined as the presence of viable fetuses identified by ultrasonography at gestational weeks 10-12. Ongoing pregnancy rate is defined as the number of participants with ongoing pregnancy divided by the number of participants with embryo transfer (ET) multiplied by 100. Here, data used for analysis was based on Merck GMA interpretation.', 'unitOfMeasure': 'Percentage of Pregnancy per ET', 'reportingStatus': 'POSTED', 'populationDescription': 'FA dataset included all randomized participants.'}, {'type': 'SECONDARY', 'title': 'Multiple Pregnancy Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'OG000'}, {'value': '208', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GERI+ Incubator', 'description': 'The embryo culture of consented participants carried out in Genea Embryo Review Instrument Plus (GERI+) incubator for both bright-field and dark-field time lapse monitoring until Day 3 of embryo culture. On Day 3, all embryos were reviewed firstly by GERI Assess software, using bright-field imaging. Finally the embryo(s) with the highest EEVA grade were transferred and were followed up until the achievement of implantation and confirmation of pregnancy.'}, {'id': 'OG001', 'title': 'Conventional Incubator', 'description': 'The embryo culture of consented participants were carried out in conventional incubator for culture until Day 3 of embryo culture. On Day 3 of embryo culture, all embryos were assessed using a bench-top microscope. The embryo(s) with optimal cell stage and grade were transferred and were followed up until the achievement of implantation and confirmation of pregnancy.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000'}, {'value': '11.4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Gestational Weeks 10 to 12', 'description': 'Multiple pregnancy is defined as a pregnancy with more than one fetus. It is identified by ultrasonography at gestational weeks 10-12. Multiple pregnancy rate was defined as the number of participants with multiple pregnancy divided by the number of participants with ongoing pregnancy multiplied by 100. Here, data used for analysis was based on Merck GMA interpretation.', 'unitOfMeasure': 'Percentage of Multiple Pregnancy', 'reportingStatus': 'POSTED', 'populationDescription': 'FA dataset included all randomized participants.'}, {'type': 'SECONDARY', 'title': 'Ectopic Pregnancy Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'OG000'}, {'value': '208', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GERI+ Incubator', 'description': 'The embryo culture of consented participants carried out in Genea Embryo Review Instrument Plus (GERI+) incubator for both bright-field and dark-field time lapse monitoring until Day 3 of embryo culture. On Day 3, all embryos were reviewed firstly by GERI Assess software, using bright-field imaging. Finally the embryo(s) with the highest EEVA grade were transferred and were followed up until the achievement of implantation and confirmation of pregnancy.'}, {'id': 'OG001', 'title': 'Conventional Incubator', 'description': 'The embryo culture of consented participants were carried out in conventional incubator for culture until Day 3 of embryo culture. On Day 3 of embryo culture, all embryos were assessed using a bench-top microscope. The embryo(s) with optimal cell stage and grade were transferred and were followed up until the achievement of implantation and confirmation of pregnancy.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.1', 'groupId': 'OG000'}, {'value': '0.5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Gestational Weeks 6 to 8', 'description': 'Ectopic pregnancy is defined as a pregnancy in which implantation takes place outside the uterine cavity. It is identified by ultrasonography at weeks 6-8. Ectopic Pregnancy Rate was defined as the number of participants with ectopic pregnancy divided by the number of participants with embryo transfer (ET) multiplied by 100. Here, data used for analysis was based on Merck GMA interpretation.', 'unitOfMeasure': 'Percentage of Pregnancy per ET', 'reportingStatus': 'POSTED', 'populationDescription': 'FA dataset included all randomized participants.'}, {'type': 'SECONDARY', 'title': 'Spontaneous Miscarriage Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'OG000'}, {'value': '208', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GERI+ Incubator', 'description': 'The embryo culture of consented participants carried out in Genea Embryo Review Instrument Plus (GERI+) incubator for both bright-field and dark-field time lapse monitoring until Day 3 of embryo culture. On Day 3, all embryos were reviewed firstly by GERI Assess software, using bright-field imaging. Finally the embryo(s) with the highest EEVA grade were transferred and were followed up until the achievement of implantation and confirmation of pregnancy.'}, {'id': 'OG001', 'title': 'Conventional Incubator', 'description': 'The embryo culture of consented participants were carried out in conventional incubator for culture until Day 3 of embryo culture. On Day 3 of embryo culture, all embryos were assessed using a bench-top microscope. The embryo(s) with optimal cell stage and grade were transferred and were followed up until the achievement of implantation and confirmation of pregnancy.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.3', 'groupId': 'OG000'}, {'value': '10.1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Gestational Weeks 10 to 12', 'description': 'Spontaneous miscarriage (SM) is the spontaneous loss of a clinical pregnancy before 20 completed weeks of gestational age (18 weeks after fertilization). In this study, the spontaneous miscarriage was tracked up to 10-12 weeks of gestational age. Spontaneous miscarriage rate was defined as the number of participants with spontaneous miscarriage divided by the number of participants with clinical pregnancy multiplied by 100. Here, data used for analysis was based on Merck GMA interpretation.', 'unitOfMeasure': 'Percentage of miscarriages', 'reportingStatus': 'POSTED', 'populationDescription': 'FA dataset included all randomized participants.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'GERI+ Incubator', 'description': 'The embryo culture of consented participants carried out in Genea Embryo Review Instrument Plus (GERI+) incubator for both bright-field and dark-field time lapse monitoring until Day 3 of embryo culture. On Day 3, all embryos were reviewed firstly by GERI Assess software, using bright-field imaging. Finally the embryo(s) with the highest EEVA grade were transferred and were followed up until the achievement of implantation and confirmation of pregnancy.'}, {'id': 'FG001', 'title': 'Conventional Incubator', 'description': 'The embryo culture of consented participants were carried out in conventional incubator for culture until Day 3 of embryo culture. On Day 3 of embryo culture, all embryos were assessed using a bench-top microscope. The embryo(s) with optimal cell stage and grade were transferred and were followed up until the achievement of implantation and confirmation of pregnancy.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '200'}, {'groupId': 'FG001', 'numSubjects': '208'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '171'}, {'groupId': 'FG001', 'numSubjects': '192'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '16'}]}], 'dropWithdraws': [{'type': 'Imaging discontinued prior completion', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Participant was non-compliant', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Cancellation of Fresh Embryo Transfer', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'BG000'}, {'value': '208', 'groupId': 'BG001'}, {'value': '408', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'GERI+ Incubator', 'description': 'The embryo culture of consented participants carried out in Genea Embryo Review Instrument Plus (GERI+) incubator for both bright-field and dark-field time lapse monitoring until Day 3 of embryo culture. On Day 3, all embryos were reviewed firstly by GERI Assess software, using bright-field imaging. Finally the embryo(s) with the highest EEVA grade were transferred and were followed up until the achievement of implantation and confirmation of pregnancy.'}, {'id': 'BG001', 'title': 'Conventional Incubator', 'description': 'The embryo culture of consented participants were carried out in conventional incubator for culture until Day 3 of embryo culture. On Day 3 of embryo culture, all embryos were assessed using a bench-top microscope. The embryo(s) with optimal cell stage and grade were transferred and were followed up until the achievement of implantation and confirmation of pregnancy.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'BG000'}, {'value': '208', 'groupId': 'BG001'}, {'value': '408', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '33.27', 'spread': '4.076', 'groupId': 'BG000'}, {'value': '33.23', 'spread': '3.996', 'groupId': 'BG001'}, {'value': '33.25', 'spread': '4.030', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'BG000'}, {'value': '208', 'groupId': 'BG001'}, {'value': '408', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '200', 'groupId': 'BG000'}, {'value': '208', 'groupId': 'BG001'}, {'value': '408', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], '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'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-01-31', 'size': 2555795, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-11-06T08:13', 'hasProtocol': True}, {'date': '2020-01-14', 'size': 500460, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-11-06T08:13', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 408}}, 'statusModule': {'whyStopped': 'Participant enrollment has remained significantly behind plan despite increased site enrollment activity.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-04-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2019-11-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-06', 'studyFirstSubmitDate': '2017-05-22', 'resultsFirstSubmitDate': '2020-11-06', 'studyFirstSubmitQcDate': '2017-05-22', 'lastUpdatePostDateStruct': {'date': '2020-12-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-11-06', 'studyFirstPostDateStruct': {'date': '2017-05-23', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-12-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical Pregnancy Rate With Positive Fetal Heart Beat (FHB)', 'timeFrame': 'Gestation Weeks 6 to 8', 'description': 'Clinical Pregnancy was defined as the pregnancy diagnosed by ultrasonographic or clinical documentation of at least one fetus with heart beat in gestational week 6 to 8. Clinical pregnancy rate with positive FHB was measured as the number of participants with FHB positive clinical pregnancy divided by number of participants with embryo transfer (ET) multiplied by 100. Here, data used for analysis was based on Merck Global Medical Affairs (GMA) interpretation.'}], 'secondaryOutcomes': [{'measure': 'Utilizable Embryos Rate', 'timeFrame': 'Day 3 of embryo culture', 'description': 'Utilizable embryos rate is defined as the number of transferred and cryopreserved embryos divided by the number embryos stage zygotes per participant multiply by 100. Here, data used for analysis was based on Merck GMA interpretation.'}, {'measure': 'Good Quality Embryos Rate', 'timeFrame': 'Day 3 of embryo culture', 'description': 'Good Quality Embryos is defined embryos with 7 or more blastomeres, less than (\\<) 25 % fragmentation, size and symmetry of blastomeres appropriate to the cell number, and no evidence of multinucleation, based on the morphology on Day 3 of embryo culture. Good quality embryos rate was defined as the number of good quality embryos divided by the number of embryos per participant multiplied by 100. Here, data used for analysis was based on Merck GMA interpretation.'}, {'measure': 'Non-viable Embryos Rate', 'timeFrame': 'Days 1 to 3 of embryo culture', 'description': 'Non-viable Embryos is defined as the embryos in which development has been arrested for at least 24 hour or in which all the cells have degenerated or lysed. Non-viable embryos rate was defined as the number of non-viable embryos divided by the number of embryos per participant multiplied by 100. Here, data used for analysis was based on Merck GMA interpretation.'}, {'measure': 'Implantation Rate (IR) With Positive Fetal Heart Beat', 'timeFrame': 'Gestational Weeks 6 to 8', 'description': 'A successful implantation is defined as the presence of one gestational sac with fetal heart beat (FHB) under ultrasonography at gestational weeks 6-8. Implantation rate (IR) was defined as the number of intrauterine gestational sacs with positive FHB under ultrasound scans at gestational weeks 6-8 divided by the total number of embryos transferred (ET) multiplied by 100. Here, data used for analysis was based on Merck GMA interpretation.'}, {'measure': 'Biochemical Pregnancy Rate', 'timeFrame': 'From Day 12 of Gestational up to Week 8', 'description': 'Biochemical Pregnancy defined as a pregnancy diagnosed only by the detection of Human Chorionic Gonadotropin (hCG) in serum or urine and that does not develop into a clinical pregnancy. Biochemical pregnancy rate was defined as the number of participants with biochemical pregnancy divided by the number of participants with embryo transfer (ET) multiplied by 100. Here, data used for analysis was based on Merck GMA interpretation.'}, {'measure': 'Ongoing Pregnancy Rate', 'timeFrame': 'Gestational Weeks 10 to 12', 'description': 'Ongoing pregnancy is defined as the presence of viable fetuses identified by ultrasonography at gestational weeks 10-12. Ongoing pregnancy rate is defined as the number of participants with ongoing pregnancy divided by the number of participants with embryo transfer (ET) multiplied by 100. Here, data used for analysis was based on Merck GMA interpretation.'}, {'measure': 'Multiple Pregnancy Rate', 'timeFrame': 'Gestational Weeks 10 to 12', 'description': 'Multiple pregnancy is defined as a pregnancy with more than one fetus. It is identified by ultrasonography at gestational weeks 10-12. Multiple pregnancy rate was defined as the number of participants with multiple pregnancy divided by the number of participants with ongoing pregnancy multiplied by 100. Here, data used for analysis was based on Merck GMA interpretation.'}, {'measure': 'Ectopic Pregnancy Rate', 'timeFrame': 'Gestational Weeks 6 to 8', 'description': 'Ectopic pregnancy is defined as a pregnancy in which implantation takes place outside the uterine cavity. It is identified by ultrasonography at weeks 6-8. Ectopic Pregnancy Rate was defined as the number of participants with ectopic pregnancy divided by the number of participants with embryo transfer (ET) multiplied by 100. Here, data used for analysis was based on Merck GMA interpretation.'}, {'measure': 'Spontaneous Miscarriage Rate', 'timeFrame': 'Gestational Weeks 10 to 12', 'description': 'Spontaneous miscarriage (SM) is the spontaneous loss of a clinical pregnancy before 20 completed weeks of gestational age (18 weeks after fertilization). In this study, the spontaneous miscarriage was tracked up to 10-12 weeks of gestational age. Spontaneous miscarriage rate was defined as the number of participants with spontaneous miscarriage divided by the number of participants with clinical pregnancy multiplied by 100. Here, data used for analysis was based on Merck GMA interpretation.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['GERI+', 'TICON', 'EEVA', 'Embryo culture', 'In Vitro Fertilization', 'Intracytoplasmic Sperm Injection'], 'conditions': ['Infertility']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://clinicaltrials.emdgroup.com/en/trial-details/?id=MS200497_0006', 'label': 'Trial Awareness and Transparency website'}, {'url': 'https://www.merckgroup.com/en/company/contact-us/medinfo-contact-map.html', 'label': 'Medical Information Location Map - Med Info Contacts'}]}, 'descriptionModule': {'briefSummary': 'The main purpose of the study was to evaluate the overall clinical value of GERI+ as an integrated embryo culture and assessment system, providing an undisturbed culture environment, continuous monitoring of embryo development and automated scoring using a predictive algorithm.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Couples with less than or equal to (\\<= ) two failed fresh In Vitro Fertilization/Intracytoplasmic Sperm Injection (IVF/ICSI) embryo transfer cycles\n* Age greater than or equal to (\\>=) 18 and \\<= 40 years\n* Body mass index (BMI): 18-30 kilogram per meter square (kg/m2)\n* Normal uterine cavity under ultrasound\n* Participant and her husband/partner must have read and signed the Informed Consent form (ICF)\n* At least four normally fertilized oocytes (2Pronuclear stage (PN)) in the current cycle\n\nExclusion Criteria:\n\n* Male with non-ejaculated sperm\n* Participants with abnormal, undiagnosed gynecological bleeding or with genitourinary malformations\n* Participants with any contraindication to Controlled Ovarian Stimulation (COS) for Assisted Reproductive Technologies (ART) or to gonadotropins\n* Planned "freeze all" cycle (oocytes or embryos)\n* Planned preimplantation genetic screening (PGS) or Pre-implantation genetic diagnosis (PGD) cycle\n* Concurrent participation in another clinical study'}, 'identificationModule': {'nctId': 'NCT03164551', 'acronym': 'TICON', 'briefTitle': 'TICON-Day 3, Time Lapse Versus Conventional Method in Day 3 Embryo Culture and Assessment', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck KGaA, Darmstadt, Germany'}, 'officialTitle': 'A Phase IV, Single-blinded, Prospective, Randomized, Controlled, Multi-center Study to Compare the Clinical Outcomes of Genea Embryo Review Instrument Plus (GERI+) Time Lapse System With a Conventional Embryo Culture and Assessment System', 'orgStudyIdInfo': {'id': 'MS200497_0006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'GERI+ Incubator', 'interventionNames': ['Device: GERI+ incubator']}, {'type': 'OTHER', 'label': 'Conventional incubator', 'interventionNames': ['Device: Conventional incubator']}], 'interventions': [{'name': 'GERI+ incubator', 'type': 'DEVICE', 'description': 'The embryo culture of consented participants were carried out in GERI+ incubator for both bright-field and dark-field time lapse monitoring until Day 3 of embryo culture. On Day 3, all embryos were reviewed firstly by GERI Assess software, using bright-field imaging. Finally the embryo(s) with the highest EEVA grade are transferred were followed up until the achievement of implantation and confirmation of pregnancy.', 'armGroupLabels': ['GERI+ Incubator']}, {'name': 'Conventional incubator', 'type': 'DEVICE', 'description': 'The embryo culture of consented participants were carried out in conventional incubator for culture until Day 3 of embryo culture. On Day 3 of embryo culture, all embryos are assessed using a bench-top microscope. The embryo(s) with optimal cell stage and grade were transferred and were followed up until the achievement of implantation and confirmation of pregnancy.', 'armGroupLabels': ['Conventional incubator']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'T3B 4N2', 'city': 'Calgary', 'country': 'Canada', 'facility': 'Cambrian Wellness Centre', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'city': 'Calgary', 'country': 'Canada', 'facility': 'Regional Fertility Program', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'zip': '7800', 'city': 'Skive', 'country': 'Denmark', 'facility': 'Skive Fertility clinic', 'geoPoint': {'lat': 56.56699, 'lon': 9.02707}}, {'city': 'Skive', 'country': 'Denmark', 'facility': 'Fertility Clinic Skive Regional Hospital', 'geoPoint': {'lat': 56.56699, 'lon': 9.02707}}, {'zip': '92140', 'city': 'Clamart', 'country': 'France', 'facility': 'Hopital Antoine Beclere', 'geoPoint': {'lat': 48.80299, 'lon': 2.26692}}, {'zip': 'I-39031', 'city': 'Bruneck (BZ)', 'country': 'Italy', 'facility': 'Krankenhaus Bruneck', 'geoPoint': {'lat': 46.79942, 'lon': 11.93429}}, {'zip': '50141', 'city': 'Florence', 'country': 'Italy', 'facility': 'Demetra S.R.L', 'geoPoint': {'lat': 43.77925, 'lon': 11.24626}}, {'zip': 'SO129', 'city': 'Florence', 'country': 'Italy', 'facility': 'Futura Diagnostica medica PMA SRL', 'geoPoint': {'lat': 43.77925, 'lon': 11.24626}}, {'zip': '55043', 'city': 'Viareggio', 'country': 'Italy', 'facility': 'USL Toscana Nordovest', 'geoPoint': {'lat': 43.86693, 'lon': 10.2502}}, {'city': 'Oslo', 'country': 'Norway', 'facility': 'Oslo University Hospital', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}, {'zip': '3710', 'city': 'Skien', 'country': 'Norway', 'facility': 'Sykehuset Telemark HF Fertilitetsavdeliningen Sor', 'geoPoint': {'lat': 59.20962, 'lon': 9.60897}}, {'zip': 'N-7006', 'city': 'Trodheim', 'country': 'Norway', 'facility': 'St. Olavs Hospital Hf, Universitetssykehuset i Trondheim'}, {'zip': '3000-075', 'city': 'Coimbra', 'country': 'Portugal', 'facility': 'Centro Hospitalar e Universitario de Coimbra', 'geoPoint': {'lat': 40.20686, 'lon': -8.41996}}, {'zip': '48903', 'city': 'Barakaldo', 'country': 'Spain', 'facility': 'Hospital de Cruces', 'geoPoint': {'lat': 43.29639, 'lon': -2.98813}}, {'zip': '8025', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Nephrology Service Fundacion Puigvert', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Granada', 'country': 'Spain', 'facility': 'Hospital Universitario Virgen de las Nieves', 'geoPoint': {'lat': 37.18817, 'lon': -3.60667}}, {'city': 'Santa Cruz de Tenerife', 'country': 'Spain', 'facility': 'Hosp Univ de Canarias', 'geoPoint': {'lat': 28.46824, 'lon': -16.25462}}], 'overallOfficials': [{'name': 'Medical Responsible', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck KGaA, Darmstadt, Germany'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck KGaA, Darmstadt, Germany', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}