Ignite Creation Date:
2025-12-25 @ 12:02 AM
Ignite Modification Date:
2025-12-25 @ 9:59 PM
Study NCT ID:
NCT04497558
Status:
COMPLETED
Last Update Posted:
2025-02-26
First Post:
2020-07-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Clinical Efficiency of Tb-ERA in Chinese RIF Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-11-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2024-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-24', 'studyFirstSubmitDate': '2020-07-28', 'studyFirstSubmitQcDate': '2020-08-01', 'lastUpdatePostDateStruct': {'date': '2025-02-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical pregnancy rate', 'timeFrame': '6 months', 'description': 'Clinical pregnancy rate in patients'}], 'secondaryOutcomes': [{'measure': 'Endometrial implantation window evaluation results', 'timeFrame': '6 months', 'description': 'Endometrial implantation window evaluation results in tested patients'}, {'measure': 'Embryo implantation rate', 'timeFrame': '6 months', 'description': 'Embryo implantation rate in patients'}, {'measure': 'Biochemical pregnancy rate', 'timeFrame': '6 months', 'description': 'Biochemical pregnancy rate in patients'}, {'measure': 'Early abortion rate', 'timeFrame': '6 months', 'description': 'Early abortion rate in patients'}, {'measure': 'Ectopic pregnancy rate', 'timeFrame': '6 months', 'description': 'Ectopic pregnancy rate in patients'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['endometrial receptivity array', 'Repeated implantation failure'], 'conditions': ['Endometrial Receptivity', 'Repeated Implantation Failure']}, 'referencesModule': {'references': [{'pmid': '23756099', 'type': 'BACKGROUND', 'citation': 'Ruiz-Alonso M, Blesa D, Diaz-Gimeno P, Gomez E, Fernandez-Sanchez M, Carranza F, Carrera J, Vilella F, Pellicer A, Simon C. The endometrial receptivity array for diagnosis and personalized embryo transfer as a treatment for patients with repeated implantation failure. Fertil Steril. 2013 Sep;100(3):818-24. doi: 10.1016/j.fertnstert.2013.05.004. Epub 2013 Jun 4.'}, {'pmid': '29259480', 'type': 'BACKGROUND', 'citation': 'Hashimoto T, Koizumi M, Doshida M, Toya M, Sagara E, Oka N, Nakajo Y, Aono N, Igarashi H, Kyono K. Efficacy of the endometrial receptivity array for repeated implantation failure in Japan: A retrospective, two-centers study. Reprod Med Biol. 2017 Jun 27;16(3):290-296. doi: 10.1002/rmb2.12041. eCollection 2017 Jul.'}, {'pmid': '35669489', 'type': 'DERIVED', 'citation': 'Zhang WB, Li H, Lu X, Chen JL, Li L, Chen JC, Wu H, Sun XX. The clinical efficiency of transcriptome-based endometrial receptivity assessment (Tb-ERA) in Chinese patients with recurrent implantation failure (RIF): A study protocol for a prospective randomized controlled trial. Contemp Clin Trials Commun. 2022 May 28;28:100928. doi: 10.1016/j.conctc.2022.100928. eCollection 2022 Aug.'}]}, 'descriptionModule': {'briefSummary': 'In order to further explore the clinical utility of endometrial receptivity array in patients with repeated implantation failure, the patients divide into the experimental group or the control group. In the experimental group, those patients undergo endometrial receptivity array. In the control group, those patients do not receive any treatment before next cycle of transfer. In the experimental group, according to the results of endometrial receptivity array, the transplantation time will be adjusted and retransplantation will be carried out. Statistical analysis of the two groups of primary endpoint and secondary endpoint are done.', 'detailedDescription': 'In the field of assisted reproduction techonology, there are still 10% of patients with repeated implantation failure. In order to further explore the clinical utility of endometrial receptivity array in patients with repeated implantation failure, the patients divide into the experimental group or the control group. In the experimental group, those patients undergo endometrial receptivity array. In the control group, those patients do not receive any treatment before next cycle of transfer. In the experimental group, according to the results of endometrial receptivity array, the transplantation time will be adjusted and retransplantation will be carried out. In the control group, no intervention will be performed. Statistical analysis of the two groups of primary endpoint (clinical pregnancy rate) and secondary endpoint (endometrial implantation window evaluation results, embryo implantation rate, biochemical pregnancy rate, early abortion rate, ectopic pregnancy rate) are done. Through the comparative analysis of clinical outcomes to verify the clinical efficacy of endometrial receptivity analysis in patients with repeated implant failure, this method will provide a new treatment for repeated implant failure population.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. People with unexplained repeated implantation failure (3 or more times of transplantation, at least 4 or more high-quality embryos failed to conceive).\n2. Age: 20-40 years old.\n3. BMI: 19 - 24.\n4. The thickness of endometrium is more than or equal to 7 mm.\n\nExclusion Criteria:\n\n1. Known causes of embryo implantation failure, such as infection, reproductive tract malformation, uterine cavity factors, immune factors, hydrosalpinx, etc.\n2. Decreased ovarian function (meet the following at least two criteria: ① 10u / L \\< basal follicle stimulating hormone (FSH) \\< 25U / L, and / or estradiol (E2) \\> 292.8pmol/l, and / or FSH / LH \\> 3; ② the number of antral follicles \\< 5-7 on the second to third day of menstruation; and (or) antimullerian hormone (AMH) \\< 0.5-1.1ng/ml.\n3. People with genetic history.\n4. Those who have done abortion and the histogenetic analysis are positive.'}, 'identificationModule': {'nctId': 'NCT04497558', 'briefTitle': 'The Clinical Efficiency of Tb-ERA in Chinese RIF Patients', 'organization': {'class': 'OTHER', 'fullName': 'ShangHai Ji Ai Genetics & IVF Institute'}, 'officialTitle': 'The Clinical Efficiency of Transcriptome-based Endometrial Receptivity Assessment (Tb-ERA) in Chinese Patients With Recurrent Implantation Failure (RIF)', 'orgStudyIdInfo': {'id': 'JIAI 2020-07'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ERA group', 'description': 'In the experimental group, those patients undergo endometrial receptivity array. According to the results of endometrial receptivity array, the transplantation time will be adjusted and retransplantation will be carried out.', 'interventionNames': ['Diagnostic Test: Endometrium biopsy']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'In the control group, those patients do not receive any treatment before next cycle of transfer. In the control group, no intervention will be performed.'}], 'interventions': [{'name': 'Endometrium biopsy', 'type': 'DIAGNOSTIC_TEST', 'description': 'In the experimental group, those patients undergo endometrial receptivity array. In the control group, those patients do not receive any treatment before next cycle of transfer. In the experimental group, according to the results of endometrial receptivity array, the transplantation time will be adjusted and retransplantation will be carried out. In the control group, no intervention will be performed.', 'armGroupLabels': ['ERA group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200011', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Shanghai Ji Ai Genetics & IVF Institute, Obstetrics and Gynecology Hospital of Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Xiaoxi Sun', 'role': 'STUDY_CHAIR', 'affiliation': 'Obstetrics and Gynecology Hospital affiliated to Fudan University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ShangHai Ji Ai Genetics & IVF Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Wenbi Zhang', 'investigatorAffiliation': 'ShangHai Ji Ai Genetics & IVF Institute'}}}}