Ignite Creation Date:
2025-12-24 @ 2:06 PM
Ignite Modification Date:
2026-01-09 @ 3:30 PM
Study NCT ID:
NCT04533295
Status:
UNKNOWN
Last Update Posted:
2021-04-23
First Post:
2020-08-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Acupuncture on IVF Pregnancy Outcomes for Women With RIF
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015670', 'term': 'Acupuncture Therapy'}], 'ancestors': [{'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 514}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-08-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-04-21', 'studyFirstSubmitDate': '2020-08-26', 'studyFirstSubmitQcDate': '2020-08-26', 'lastUpdatePostDateStruct': {'date': '2021-04-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'CPR', 'timeFrame': '1 month after ET', 'description': 'Clinical pregnancy rate'}], 'secondaryOutcomes': [{'measure': 'OPR', 'timeFrame': '3 month after ET', 'description': 'ongoing pregnancy rate'}, {'measure': 'LBR', 'timeFrame': '10 month after ET', 'description': 'Live birth rate'}, {'measure': 'Biochemical indexes', 'timeFrame': 'one year', 'description': 'Biochemical indexes'}, {'measure': 'Questionnaire score', 'timeFrame': 'one year', 'description': 'Questionnaire score'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Repeated Implantation Failure']}, 'descriptionModule': {'briefSummary': 'The randomized, placebo-controlled multicenter trial is conducted in five centers in China. After screening and obtaining the signed informed consent , the participants are randomly divided into two groups: acupuncture +IVF group and sham acupuncture +IVF group.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Married women aged 25-40;\n2. Repeated implantation failure for unknown reasons (after 3 or more consecutive cycles of embryo transfer, or cumulative transfer of ≥6 high-quality cleavage embryos or 4 high-quality blastocysts without clinical pregnancy);\n3. Transplantable Day 3 high-quality frozen embryos or frozen blastocysts (≥3BB);\n4. Estrogen and progesterone replacement therapy (HRT), endometrial thickness ≥7mm on the day of endometrial transformation.\n\nExclusion Criteria:\n\nPatients who met any of the following conditions were not included.\n\n1. Those who prepare for PGD;\n2. Recipients of egg donors;\n3. Chromosomal abnormalities in both or one of the couples (excluding chromosome polymorphism);\n4. patients with implantation failure due to known embryonic factors;\n5. Uterine lesions that may affect implantation (including uterine malformation, uterine tuberculosis, history of intrauterine adhesions, submucosal fibroids, adenomyosis, \\>4cm intramural fibroids)\n6. Repeated spontaneous abortion (2 or more fetal loss before 28 weeks of gestation);\n7. Patients with other endocrine diseases, such as thyroid disease, hyperprolactinemia, insulin resistance, diabetes, adrenal disease, etc., and poor control of hormone levels in the last 3 months;\n8. Clearly diagnosed autoimmune diseases such as systemic lupus erythematosus, rheumatoid arthritis, antiphospholipid syndrome, etc.;\n9. Hydrosalpinx untreated;\n10. BMI less than 18 and higher than 25kg/m2;\n11. People with previous history of needle sickness;\n12. Those who had previously participated in this study or had received acupuncture treatment in the past 3 months.\n13. Any situation that researchers consider inappropriate for participating in this study.'}, 'identificationModule': {'nctId': 'NCT04533295', 'briefTitle': 'The Effect of Acupuncture on IVF Pregnancy Outcomes for Women With RIF', 'organization': {'class': 'OTHER', 'fullName': 'Huazhong University of Science and Technology'}, 'officialTitle': 'The Effect of Acupuncture on IVF Pregnancy Outcomes for Women With Recurrent Implantation Failure: a Multi-center Randomized Controlled Clinical Trial', 'orgStudyIdInfo': {'id': '2019CR110'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Acupuncture and IVF', 'description': 'Acupuncture and IVF', 'interventionNames': ['Device: acupuncture and IVF']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham acupuncture and IVF', 'description': 'Sham acupuncture and IVF', 'interventionNames': ['Device: sham acupuncture and IVF']}], 'interventions': [{'name': 'acupuncture and IVF', 'type': 'DEVICE', 'description': 'Acupuncture was performed three times a week for 30 minutes each time, starting from the 5th day of menstruation and ending within 24 hours after embryo transfer.', 'armGroupLabels': ['Acupuncture and IVF']}, {'name': 'sham acupuncture and IVF', 'type': 'DEVICE', 'description': 'Sham acupuncture was performed three times a week for 30 minutes each time, starting from the 5th day of menstruation and ending within 24 hours after embryo transfer.', 'armGroupLabels': ['Sham acupuncture and IVF']}]}, 'contactsLocationsModule': {'locations': [{'zip': '430030', 'city': 'Wuhan', 'state': 'Hubei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Cuihong Zheng, professor', 'role': 'CONTACT'}, {'name': 'Minming Zhang, professor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Tongji Hospital,Tongji medical college,HUST', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}], 'centralContacts': [{'name': 'Cuihong Zheng, professor', 'role': 'CONTACT', 'email': 'chzheng@tjh.tjmu.edu.cn', 'phone': '86-27-83663275'}], 'overallOfficials': [{'name': 'Minming Zhang, professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Huazhong University of Science and Technology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Huazhong University of Science and Technology', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'associate professor', 'investigatorFullName': 'Cui Hong Zheng', 'investigatorAffiliation': 'Huazhong University of Science and Technology'}}}}