Ignite Creation Date:
2025-12-25 @ 3:17 AM
Ignite Modification Date:
2025-12-26 @ 1:56 AM
Study NCT ID:
NCT05189405
Status:
UNKNOWN
Last Update Posted:
2022-01-12
First Post:
2021-12-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
3 Year Retrospective Analysis of IVF in Comparison With INVOcell
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 450}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-10-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2022-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-12-29', 'studyFirstSubmitDate': '2021-12-29', 'studyFirstSubmitQcDate': '2021-12-29', 'lastUpdatePostDateStruct': {'date': '2022-01-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Embryo development', 'timeFrame': '5 days', 'description': 'Characteristics of embryo quality and phase of development and transfer rates'}, {'measure': 'Clinical pregnancy rate', 'timeFrame': '5 days', 'description': 'Clinical pregnancy rate'}, {'measure': 'Live birth rate', 'timeFrame': '5 days', 'description': 'Live birth rate'}], 'secondaryOutcomes': [{'measure': 'Maternal Adverse Events', 'timeFrame': '5 days', 'description': 'Adverse events noted by the women that received IVF and INVOcell IVC'}, {'measure': 'Offspring adverse events', 'timeFrame': '5 days', 'description': 'Adverse events noted for the offspring'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Infertility']}, 'descriptionModule': {'briefSummary': 'Retrospective chart review of data on the use of traditional IVF and INVOcell IVC collected from clinics using both technologies. The retrospective data will be utilized for a comparison of the two methods.', 'detailedDescription': 'The following aspects of data will be collected to support the analysis of the two methods\n\n* Procedure details for including oil overlay and incubation time frame\n* Characteristics of embryo quality and phase of development and transfer rates\n* Clinical pregnancy rate\n* Live birth rate Secondary: Data regarding safety\n* Adverse events noted by the women that received IVF and INVOcell IVC\n* Adverse events noted for the offspring'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '42 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects that have received infertility treatment with either INVOcell IVC or standard IVF during the same timeframe. All subjects treated with the standard of care IVF method during the same timeframe that the center used INVOcell IVC were included in the retrospective data collection.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects that have received infertility treatment with either INVOcell IVC or standard IVF during the same timeframe. All subjects treated with the standard of care IVF method during the same timeframe that the center used INVOcell IVC were included in the retrospective data collection.\n\nExclusion Criteria:\n\n* Not applicable'}, 'identificationModule': {'nctId': 'NCT05189405', 'briefTitle': '3 Year Retrospective Analysis of IVF in Comparison With INVOcell', 'organization': {'class': 'INDUSTRY', 'fullName': 'INVO Bioscience, Inc.'}, 'officialTitle': "A 3 Year Retrospective Analysis of Fertility Clinic's of In Vitro Fertilization (IVF) in Comparison With INVOcell Intravaginal Culture (INVOcell IVC) Device", 'orgStudyIdInfo': {'id': 'CP-019'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'INVOcell IVC', 'description': 'IVF using intravaginal incubation with INVOcell device for embryo development.', 'interventionNames': ['Device: INVOcell IVC']}, {'label': 'Traditional IVF (tIVF)', 'description': 'Traditional IVF using laboratory equipment and incubators for embryo development'}], 'interventions': [{'name': 'INVOcell IVC', 'type': 'DEVICE', 'description': 'Embryo development in intravaginal incubation', 'armGroupLabels': ['INVOcell IVC']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27607', 'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Carolina Conceptions', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'zip': '29615', 'city': 'Greenville', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Piedmont Reproductive Endocrinology Group', 'geoPoint': {'lat': 34.85262, 'lon': -82.39401}}, {'zip': '76022', 'city': 'Bedford', 'state': 'Texas', 'country': 'United States', 'facility': 'CARE Fertility', 'geoPoint': {'lat': 32.84402, 'lon': -97.14307}}, {'zip': '23452', 'city': 'Virginia Beach', 'state': 'Virginia', 'country': 'United States', 'facility': 'THE NEW HOPE CENTER for Reproductive Medicine', 'geoPoint': {'lat': 36.85293, 'lon': -75.97799}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'INVO Bioscience, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}