Ignite Creation Date:
2025-12-26 @ 4:00 PM
Ignite Modification Date:
2025-12-29 @ 7:18 AM
Study NCT ID:
NCT04693806
Status:
COMPLETED
Last Update Posted:
2023-05-03
First Post:
2020-12-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Embryo Culture Under a Continuous CO2 Setting Versus a Sequential CO2 Setting
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 102}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-12-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2022-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-02', 'studyFirstSubmitDate': '2020-12-30', 'studyFirstSubmitQcDate': '2020-12-31', 'lastUpdatePostDateStruct': {'date': '2023-05-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'blastulation rate', 'timeFrame': 'approximately one week', 'description': 'the number of zygotes that reach the blastocyst stage'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Infertility']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if embryo culture under a single CO2 setting improves blastocyst formation rate.', 'detailedDescription': "Following enrollment, patients will undergo ovarian stimulation and oocyte retrieval per routine as previously consented to at the clinic. IVF stimulation protocol will be at the discretion of the patient's individual provider, per routine. Intracytoplasmic Sperm Injection (ICSI) will be performed and embryos will be cultured to the blastocyst stage per routine. There are no changes to the embryology care itself, the only difference within the study is the CO2 level within the incubator pending the patient's randomization."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Major Inclusion Criteria for participants:\n\n1\\. Patients undergoing IVF stimulation cycle with plan for subsequent FET\n\nMajor Exclusion Criteria for participants:\n\n1. All patients who do not voluntarily give their written consent for participation\n2. Male partner with \\<100,000 total motile spermatozoa per ejaculate (donor sperm is acceptable)\n3. Use of surgical procedures to obtain sperm'}, 'identificationModule': {'nctId': 'NCT04693806', 'briefTitle': 'The Effect of Embryo Culture Under a Continuous CO2 Setting Versus a Sequential CO2 Setting', 'organization': {'class': 'OTHER', 'fullName': 'Reproductive Medicine Associates of New Jersey'}, 'officialTitle': 'The Effect of Embryo Culture Under a Continuous CO2 Setting Versus a Sequential CO2 Setting', 'orgStudyIdInfo': {'id': 'RMA-2020-04'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Continuous CO2 Level', 'description': 'embryos will remain in a single incubator set at a continuousCO2 level', 'interventionNames': ['Other: Continuous CO2 Level']}, {'type': 'NO_INTERVENTION', 'label': 'Sequential CO2 Level', 'description': 'Current standard of care'}], 'interventions': [{'name': 'Continuous CO2 Level', 'type': 'OTHER', 'description': 'Embryos will be cultured in a single, continuous CO2 setting', 'armGroupLabels': ['Continuous CO2 Level']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07920', 'city': 'Basking Ridge', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Reproductive Medicine Associates of New Jersey', 'geoPoint': {'lat': 40.70621, 'lon': -74.54932}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Reproductive Medicine Associates of New Jersey', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}