Ignite Creation Date:
2025-12-24 @ 4:45 PM
Ignite Modification Date:
2025-12-28 @ 11:02 AM
Study NCT ID:
NCT00588250
Status:
TERMINATED
Last Update Posted:
2023-05-08
First Post:
2007-12-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Trial of Novel Implantation Promoting Medium (EmbryoGlue) to Improve IVF Success Rates
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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'whyStopped': 'Implantation rate significantly lower in treatment group than Controls.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2003-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2005-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-05', 'studyFirstSubmitDate': '2007-12-22', 'studyFirstSubmitQcDate': '2007-12-22', 'lastUpdatePostDateStruct': {'date': '2023-05-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-01-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pregnancy Rate', 'timeFrame': 'one month'}], 'secondaryOutcomes': [{'measure': 'Implantation rate', 'timeFrame': 'two months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Embryo Implantation', 'Infertility']}, 'descriptionModule': {'briefSummary': 'Hypothesis: a special solution for improving human embryo implantation, when added to the solution during embryo transfer, will improve implantation rates in embryo transfers using previously frozen embryos.', 'detailedDescription': 'EmbryoGlue (TM) is added to embryo transfer solutions immediately prior to the transfer of frozen-thawed human embryos before placement of embryos into the patient uterus.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Frozen embryo transfer patients, men over the age of 18 and women between the ages of 18 and 42 completed years (if using their own eggs and with embryos frozen before 39 completed years) or 18 to 50 completed years if using donated eggs.\n\nExclusion Criteria:\n\n* Prior participation in this study, blastocyst transfers, single embryo transfer for medical reasons, prior embryo transfer with large amount of blood on the outside of the catheter, \\> or = 3 consecutive failed embryo transfers at Mayo Clinic (fresh or frozen-thawed cycles).'}, 'identificationModule': {'nctId': 'NCT00588250', 'briefTitle': 'Clinical Trial of Novel Implantation Promoting Medium (EmbryoGlue) to Improve IVF Success Rates', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Prospective Randomized Clinical Trial of Novel Implantation Promoting Medium (EmbryoGlue) to Improve IVF Success Rates', 'orgStudyIdInfo': {'id': '876-04'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A', 'interventionNames': ['Other: EmbryoGlue']}, {'type': 'NO_INTERVENTION', 'label': 'B'}], 'interventions': [{'name': 'EmbryoGlue', 'type': 'OTHER', 'description': 'G2 culture media from Vitrolife which contains hyaluronic acid', 'armGroupLabels': ['A']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Dean E Morbeck, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Dean E. Morbeck, PhD', 'oldOrganization': 'Mayo Clinic'}}}}