Ignite Creation Date:
2025-12-24 @ 3:14 PM
Ignite Modification Date:
2026-02-28 @ 2:51 AM
Study NCT ID:
NCT00541892
Status:
WITHDRAWN
Last Update Posted:
2015-05-20
First Post:
2007-10-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sibling Oocyte Study of Medium for In Vitro Fertilization/Intracytoplasmic Sperm Injection (IVF/ICSI) With no Human Serum Albumine
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003470', 'term': 'Culture Media'}], 'ancestors': [{'id': 'D019995', 'term': 'Laboratory Chemicals'}, {'id': 'D020313', 'term': 'Specialty Uses of Chemicals'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'senior coworker retired', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2007-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-19', 'studyFirstSubmitDate': '2007-10-09', 'studyFirstSubmitQcDate': '2007-10-09', 'lastUpdatePostDateStruct': {'date': '2015-05-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-10-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fertilization', 'timeFrame': '24 hours'}, {'measure': 'Cleavage', 'timeFrame': '48 hours'}, {'measure': 'Embryo score', 'timeFrame': '48 hours'}, {'measure': 'Embryos used', 'timeFrame': '48 hours'}]}, 'conditionsModule': {'keywords': ['Cell Culture Techniques'], 'conditions': ['In Vitro Fertilization', 'Infertility']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if a new medium with no human serum albumine added is as good as the media conventionally used for IVF/ICSI.', 'detailedDescription': 'Cells attained in IVF/ICSI procedures are kept in a medium that nurture the cells. Until now all such media have contained human serum albumine. The purpose of this study is to determine if a new medium with no human serum albumine added is as good as the media conventionally used for IVF/ICSI.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '38 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Couples seeking IVF/ICSI.\n* Female under 38 years of age.\n* No more than two previous IVF/ICSI treatments without pregnancy.\n* Regular menstruation periods.\n* No endocrine disease that requires treatment in the female.\n* BMI below 30 in the female.\n* At least 8 mature follicles upon monitoring or 6 MII oocytes upon ICSI.\n* Written informed consent.\n\nExclusion Criteria:\n\n* Low responders to FSH.\n* Females in danger of developing OHSS.\n* Sperm sample below ICSI-quality.'}, 'identificationModule': {'nctId': 'NCT00541892', 'briefTitle': 'Sibling Oocyte Study of Medium for In Vitro Fertilization/Intracytoplasmic Sperm Injection (IVF/ICSI) With no Human Serum Albumine', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Sykehuset Telemark'}, 'officialTitle': 'Sibling Oocyte Study of Medium for IVF/ICSI With no Human Serum Albumine', 'orgStudyIdInfo': {'id': 's-05249'}, 'secondaryIdInfos': [{'id': '14231(NSD)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Medium with no human serum albumine added', 'interventionNames': ['Other: Medium with no human serum albumine added']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Conventional medium', 'interventionNames': ['Other: Conventional medium']}], 'interventions': [{'name': 'Medium with no human serum albumine added', 'type': 'OTHER', 'description': 'See above', 'armGroupLabels': ['1']}, {'name': 'Conventional medium', 'type': 'OTHER', 'description': 'See above', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3901', 'city': 'Porsgrunn', 'state': 'Telemark', 'country': 'Norway', 'facility': 'Fertilitetsklinikken Sør', 'geoPoint': {'lat': 59.14054, 'lon': 9.6561}}], 'overallOfficials': [{'name': 'Jarl Kahn, Dr. Med', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Fertilitetsklinikken Sør'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sykehuset Telemark', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Cellcura AS', 'class': 'INDUSTRY'}, {'name': 'Vekst i Grenland', 'class': 'UNKNOWN'}, {'name': 'Innovation Norway', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD', 'investigatorFullName': 'Hans Ivar Hanevik', 'investigatorAffiliation': 'Sykehuset Telemark'}}}}