Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2026-02-28 @ 7:10 PM
Study NCT ID:
NCT01767805
Status:
COMPLETED
Last Update Posted:
2013-01-14
First Post:
2013-01-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Culture Conditions on the Embryo Quality
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D010100', 'term': 'Oxygen'}], 'ancestors': [{'id': 'D018011', 'term': 'Chalcogens'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D005740', 'term': 'Gases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 790}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'completionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-01-10', 'studyFirstSubmitDate': '2013-01-08', 'studyFirstSubmitQcDate': '2013-01-10', 'lastUpdatePostDateStruct': {'date': '2013-01-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-01-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'embryo quality', 'timeFrame': 'day 1- day 3'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Embryo Development']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare different culture conditions. The effect of the type of incubator (standard versus mini-incubator) and the effect of the oxygen concentration (5% versus 20%) will be evaluated on the embryo quality'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '3 Days', 'minimumAge': '1 Day', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* embryos of patients younger than 36 years old\n\nExclusion Criteria:\n\n* embryos of patients older than 36 years old'}, 'identificationModule': {'nctId': 'NCT01767805', 'briefTitle': 'Impact of Culture Conditions on the Embryo Quality', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Gasthuisberg'}, 'orgStudyIdInfo': {'id': 'ML4563'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Type of incubator', 'description': 'Embryos are cultured in a standard incubator or a mini-incubator', 'interventionNames': ['Procedure: Standard incubator', 'Procedure: Mini incubator']}, {'type': 'OTHER', 'label': 'Oxygen concentration', 'description': 'Embryos are cultured in an incubator with a gas mixture with 20% oxygen or with 5% oxygen', 'interventionNames': ['Procedure: 5% oxygen', 'Procedure: 20% oxygen']}], 'interventions': [{'name': 'Standard incubator', 'type': 'PROCEDURE', 'armGroupLabels': ['Type of incubator']}, {'name': 'Mini incubator', 'type': 'PROCEDURE', 'armGroupLabels': ['Type of incubator']}, {'name': '5% oxygen', 'type': 'PROCEDURE', 'armGroupLabels': ['Oxygen concentration']}, {'name': '20% oxygen', 'type': 'PROCEDURE', 'armGroupLabels': ['Oxygen concentration']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3000', 'city': 'Leuven', 'state': 'Leuven', 'country': 'Belgium', 'facility': 'University Hospital Leuven, Catholic University Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'city': 'Leuven', 'country': 'Belgium', 'facility': 'University Hospital Leuven, Catholic University Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Gasthuisberg', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr.', 'investigatorFullName': "Thomas D'Hooghe", 'investigatorAffiliation': 'University Hospital, Gasthuisberg'}}}}