Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2025-12-27 @ 11:53 PM
Study NCT ID:
NCT04538560
Status:
UNKNOWN
Last Update Posted:
2022-01-11
First Post:
2020-08-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preimplantation Genetic Testing for Aneuploidy of Polar Bodies
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': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-10-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2022-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-01-09', 'studyFirstSubmitDate': '2020-08-30', 'studyFirstSubmitQcDate': '2020-08-30', 'lastUpdatePostDateStruct': {'date': '2022-01-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cumulative live birth rate', 'timeFrame': '22 months'}], 'secondaryOutcomes': [{'measure': 'abortion rate', 'timeFrame': '22 months'}, {'measure': 'time required to obtained a live birth', 'timeFrame': '22 months'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['poor ovarian respond，', 'advanced age', 'Preimplantation Genetic Testing'], 'conditions': ['Subfertility']}, 'descriptionModule': {'briefSummary': 'This study intends to randomly group the patients with advanced maternal age and poor ovarian response, and the study group will undergo polar body biopsy, and the next-generation sequencing(NGS) technology will be used to evaluate the polar body euploidy and then predict the euploidy of the oocyte. Embryo transfer priority according to the NGS test results and morphological scores. In the control group undergo routine culture and the transfer priority is determined according to the morphological score only. The transfer of frozen embryos at the cleavage or blastocyst stage was permitted. Cumulative live birth rate, miscarriage rate and time required to obtain a live birth up to two ovulatory cycles in a year.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '42 Years', 'minimumAge': '36 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* patients between their 36th and 42st birthdays;\n* absence of any type of genetic abnormality in the patient's personal and family history;\n* MⅡ oocytes: 2-9 .\n\nExclusion Criteria:\n\n* treatment involving donor oocytes;\n* any type of genetic abnormality or family history of genetic abnormality in subject or partner;\n* with assisted reproductive technology and pregnancy contraindications and with diseases that have a definite effect on pregnancy;\n* poor embryo quality in previous cycles;\n* Preimplantation genetic testing for aneuploidy(PGT-A) cycles;\n* MⅡ oocytes ≥10 or ≤ 1;\n* three or more previous failed IVF or Intracytoplasmic sperm injection(ICSI) cycles."}, 'identificationModule': {'nctId': 'NCT04538560', 'briefTitle': 'Preimplantation Genetic Testing for Aneuploidy of Polar Bodies', 'organization': {'class': 'OTHER', 'fullName': 'Reproductive & Genetic Hospital of CITIC-Xiangya'}, 'officialTitle': 'Preimplantation Genetic Testing for Aneuploidy by Next-generation Sequencing of Polar Bodies in Advanced Maternal Age With Poor Ovarian Responders: a Randomized Clinical Trial (Preliminary Experiments)', 'orgStudyIdInfo': {'id': 'P2020002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Polar body biopsy group', 'description': 'The study group will undergo polar body biopsy, and the NGS technology will be used to evaluate the polar body euploidy and then predict the euploidy of the oocyte. Embryo transfer priority according to the NGS test results and morphological scores.', 'interventionNames': ['Procedure: polar body biopsy']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'The control group will undergo routine culture and the transfer priority is determined according to the morphological score only.'}], 'interventions': [{'name': 'polar body biopsy', 'type': 'PROCEDURE', 'description': 'Undergo polar body biopsy, and the NGS technology will be used to evaluate the polar body euploidy and then predict the euploidy of the oocyte. Embryo transfer priority according to the NGS test results and morphological scores.', 'armGroupLabels': ['Polar body biopsy group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '410000', 'city': 'Changsha', 'state': 'Hunan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'xiaojuan Wang, Doc', 'role': 'CONTACT', 'email': '646829625@qq.com', 'phone': '+86-731-82355100'}, {'name': 'Ge Lin, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Reproductive and Genetic Hospital of Citic-xiangya', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Reproductive & Genetic Hospital of CITIC-Xiangya', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}