Ignite Creation Date:
2025-12-25 @ 12:37 AM
Ignite Modification Date:
2026-02-25 @ 8:25 PM
Study NCT ID:
NCT03687567
Status:
COMPLETED
Last Update Posted:
2022-01-11
First Post:
2018-09-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Retrospective Study on the Effect of HBA or HBB Genetic Defects on Early Embryonic Development
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013789', 'term': 'Thalassemia'}, {'id': 'D007246', 'term': 'Infertility'}], 'ancestors': [{'id': 'D000745', 'term': 'Anemia, Hemolytic, Congenital'}, {'id': 'D000743', 'term': 'Anemia, Hemolytic'}, {'id': 'D000740', 'term': 'Anemia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006453', 'term': 'Hemoglobinopathies'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 737}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-10', 'studyFirstSubmitDate': '2018-09-26', 'studyFirstSubmitQcDate': '2018-09-26', 'lastUpdatePostDateStruct': {'date': '2022-01-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Gardner grading of blastocysts', 'timeFrame': 'embryo cultured in-vitro for 5-7 days', 'description': 'development status of blastocysts'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Thalassemia,Embryonic Development,Reproductive Sterility and Infertility']}, 'descriptionModule': {'briefSummary': 'Thalassemia is an anemia or pathological state caused by compounding absently or inadequately of one or more globin chains of hemoglobin due to the defects of the globin gene,and the carrying rate is high in southern China. Although there are many studies of Thalassemia, the relationship between the globin gene defects and the early embryo development has not been reported.\n\nThis study intends to carry out a retrospective analysis on the embryonic development of the patients with thalassemia assisted by PGD from January 1, 2011 to now in our hospital, to explore whether the HBA or HBB gene defects have a certain influence on the early embryo development, so as to accumulate certain data for reproductive health research.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'One or both of infertility couples with thalassemia take PGD treatment.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* infertility couples with thalassemia(one or both )\n* infertility couples treat by PGD\n\nExclusion Criteria:\n\n* abortion of amplification for blastula biopsy\n* PGD without diagnostic results or with unclear diagnostic results\n* embryos with both HBA and HBB genetic defect'}, 'identificationModule': {'nctId': 'NCT03687567', 'briefTitle': 'A Retrospective Study on the Effect of HBA or HBB Genetic Defects on Early Embryonic Development', 'organization': {'class': 'OTHER', 'fullName': 'Reproductive & Genetic Hospital of CITIC-Xiangya'}, 'officialTitle': 'A Retrospective Study on the Effect of HBA or HBB Genetic Defects on Early Embryonic Development', 'orgStudyIdInfo': {'id': 'KYXM-201804'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'HBA', 'description': 'alpha-Thalassemia', 'interventionNames': ['Procedure: Preimplantation genetic diagnosis']}, {'label': 'HBB', 'description': 'beta-Thalassemia', 'interventionNames': ['Procedure: Preimplantation genetic diagnosis']}], 'interventions': [{'name': 'Preimplantation genetic diagnosis', 'type': 'PROCEDURE', 'armGroupLabels': ['HBA', 'HBB']}]}, 'contactsLocationsModule': {'locations': [{'zip': '410008', 'city': 'Changsha', 'state': 'Hunan', 'country': 'China', 'facility': 'Reproductive & Genetic Hospital of CITIC-XIANGYA', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}], 'overallOfficials': [{'name': 'Liang Hu, MD,PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Reproductive & Genetic Hospital of CITIC-Xiangya'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Reproductive & Genetic Hospital of CITIC-Xiangya', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}