Ignite Creation Date:
2025-12-24 @ 5:45 PM
Ignite Modification Date:
2026-01-02 @ 12:22 PM
Study NCT ID:
NCT05216068
Status:
COMPLETED
Last Update Posted:
2025-02-20
First Post:
2022-01-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigation and Diagnosis of the Chromosome Variation in Donated/abandoned Blastocyst
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014178', 'term': 'Translocation, Genetic'}, {'id': 'D000026', 'term': 'Abortion, Habitual'}], 'ancestors': [{'id': 'D002869', 'term': 'Chromosome Aberrations'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D000022', 'term': 'Abortion, Spontaneous'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 57}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2024-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-19', 'studyFirstSubmitDate': '2022-01-23', 'studyFirstSubmitQcDate': '2022-01-26', 'lastUpdatePostDateStruct': {'date': '2025-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blastocyst aneuploidy rate', 'timeFrame': '28 days', 'description': 'anormal Karyotype according to human genome 19 or updated version'}], 'secondaryOutcomes': [{'measure': 'Whole genome amplification rate', 'timeFrame': '7 days', 'description': 'success rate'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pre-implantation genetic diagnosis', 'balanced reciprocal translocation (BRT)', 'structural variation (SV)', 'next generation sequencing', 'abandoned blastocysts'], 'conditions': ['Chromosome Translocation', 'Genetic Disorders in Pregnancy', 'Recurrent Miscarriage']}, 'descriptionModule': {'briefSummary': "Blastocysts derived from patients seeking infertility treatment were generated by in vitro fertilization and embryo culture as previously described, and were evaluated using the Gardner system. As part of the embryo selection process, cells of TE biopsy were collected, and blastocysts were vitrified. The clinical TE biopsies were subjected to whole genome amplification (WGA) with SurePlex reagents (Illumina) followed by NGS-based PGT-A using Illumina's VeriSeq kit (Illumina) on a MiSeq system (Illumina) according to the manufacturer's protocol.", 'detailedDescription': 'Collected 200 donate abandonment embryos (well-developed blastocysts) for research under the National Assisted Reproduction Act of Taiwan.\n\n1. Collected 200 donate abandonment embryos: Five to six days after egg retrieval, well-developed embryos (called blastocysts).\n2. Blastocysts derived from patients seeking infertility treatment were generated.\n3. Embryos biopsies for PGT-A (by use of NGS platforms from our institute) will be used for the validation of our Lab QC embryo.\n4. To standardize the operating procedures\n5. Paper writing.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* the surplus blastocysts\n* parents consent to donate the embryos\n\nExclusion Criteria:\n\n* not agree to participate in this program\n* whose embryo morphology and quality do not meet the technical requirements for genetic testing'}, 'identificationModule': {'nctId': 'NCT05216068', 'briefTitle': 'Investigation and Diagnosis of the Chromosome Variation in Donated/abandoned Blastocyst', 'organization': {'class': 'OTHER', 'fullName': 'Chang Gung Memorial Hospital'}, 'officialTitle': 'Investigation and Diagnosis of the Chromosome Variation in Donated/abandoned Blastocyst', 'orgStudyIdInfo': {'id': 'CMRPG8M0241'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'donated abandonment embryos', 'description': 'Embryos biopsies for PGT-A (by use of NGS platforms from our institute) will be used for the validation of our Lab QC.', 'interventionNames': ['Diagnostic Test: NGS']}], 'interventions': [{'name': 'NGS', 'type': 'DIAGNOSTIC_TEST', 'description': 'Based on the next generation sequencing (NGS), WES can identify single nucleotide variants (SNVs) and small variants.', 'armGroupLabels': ['donated abandonment embryos']}]}, 'contactsLocationsModule': {'locations': [{'zip': '123', 'city': 'Kaohsiung City', 'country': 'Taiwan', 'facility': 'Chang Gung Memorial Hospital', 'geoPoint': {'lat': 22.61626, 'lon': 120.31333}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chang Gung Memorial Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}