Ignite Creation Date:
2025-12-25 @ 3:54 AM
Ignite Modification Date:
2025-12-26 @ 2:43 AM
Study NCT ID:
NCT06767202
Status:
COMPLETED
Last Update Posted:
2025-07-18
First Post:
2025-01-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Relationship Between Exposure to Phenols and Pregnancy Outcomes After Embryo Transfer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Urine'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-03-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-17', 'studyFirstSubmitDate': '2025-01-06', 'studyFirstSubmitQcDate': '2025-01-06', 'lastUpdatePostDateStruct': {'date': '2025-07-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of clinical pregnancy patients', 'timeFrame': 'From the date of randomization until the termination of pregnancy', 'description': 'Rate of biochemical pregnancy, clinical pregnancy and post-natal patients'}], 'secondaryOutcomes': [{'measure': 'Rate of the health newborn', 'timeFrame': 'From the date of randomization until the termination of pregnancy', 'description': 'gestational age/preterm birth, physical health at birth, the incidence of systemic abnormalities or diseases, and other health outcomes'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Embryo Transfer', 'Dietary polyphenols', 'bisphenols'], 'conditions': ['Embryo Transfer']}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to explore the association between phenol exposure and pregnancy outcome after embryo transfer. The main question it aims to answer \\[is/are\\]:\n\nWhether exposure to phenols is associated with adverse pregnancy outcomes in pregnant women undergoing assisted reproductive technology?', 'detailedDescription': 'First of all, paper questionnaires were used in this study, including general information questionnaire, health effect questionnaire, health survey summary form, and dietary assessment questionnaire. Secondly, obtain the relevant information of the medical record system, including: assisted reproduction protocol, IVF examination results, B-ultrasound examination results, laboratory test indicators, pregnancy outcome information and newborn information. Finally, urine samples were detected using a high performance liquid chromatography mass spectrometer.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Pregnant women undergoing assisted reproductive technology in Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei Province, China from 2024 to 2025', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Chinese citizens over the age of 20;\n2. IVF/ICSI assisted reproductive treatment in our center;\n3. Complete clinical data, reproductive outcomes and questionnaire data of both sexes;\n4. Knowing about this research and voluntarily accepting this research;\n\nExclusion Criteria:\n\n1. The patient receives sperm or egg donation treatment;\n2. The patient gave up the egg collection operation due to various reasons, and the cycle was canceled;\n3. The patient abandons treatment before achieving clinical pregnancy, but the fertile frozen embryo is not transferred;\n4. There are contraindications to pregnancy, such as serious liver and kidney diseases, malignant tumors, serious mental diseases, uncorrected coagulation function abnormalities or endocrine indicators abnormalities;\n5. Incomplete or missing clinical data or follow-up data;'}, 'identificationModule': {'nctId': 'NCT06767202', 'briefTitle': 'Relationship Between Exposure to Phenols and Pregnancy Outcomes After Embryo Transfer', 'organization': {'class': 'OTHER', 'fullName': 'Tongji Hospital'}, 'officialTitle': 'Relationship Between Exposure to Phenols and Pregnancy Outcomes After Embryo Transfer', 'orgStudyIdInfo': {'id': 'liukeqin0208'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pregnant women undergoing assisted reproductive technology in Tongji Hospital, Wuhan City, Hubei Pro', 'description': '1. Chinese citizens over the age of 20;\n2. IVF/ICSI assisted reproductive treatment in our center;\n3. Complete clinical data, reproductive outcomes and questionnaire data of both sexes;\n4. Knowing about this research and voluntarily accepting this research;'}]}, 'contactsLocationsModule': {'locations': [{'zip': '430030', 'city': 'Wuhan', 'state': 'Hubei', 'country': 'China', 'facility': 'Reproductive center，tongji hospital，huazhong university of science and technology', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'keqin liu', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'keqin liu', 'investigatorAffiliation': 'Tongji Hospital'}}}}