Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2026-03-03 @ 8:11 AM
Study NCT ID:
NCT03804294
Status:
UNKNOWN
Last Update Posted:
2019-01-17
First Post:
2019-01-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Vitamin D on Outcome of Assisted Reproductive Technology(ART);
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'serum'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 4000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-11-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2020-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-01-15', 'studyFirstSubmitDate': '2019-01-11', 'studyFirstSubmitQcDate': '2019-01-11', 'lastUpdatePostDateStruct': {'date': '2019-01-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'clinical pregnancy rates', 'timeFrame': '12 weeks after transplantation', 'description': 'Time Frame:\n\nthe presence of an intrauterinesac with an embryonic pole demonstrating cardiacactivity'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['ART']}, 'referencesModule': {'references': [{'pmid': '32412142', 'type': 'DERIVED', 'citation': 'Chen Y, Liu D, Zeng L, Xu H, Jiang H, Yang R, Wang H, Yan L, Li R, Qiao J, Zhi X. Effect of serum 25-hydroxyvitamin D levels on sperm quality and assisted reproductive technology outcomes for men of infertile Chinese couples. Andrology. 2020 Sep;8(5):1277-1286. doi: 10.1111/andr.12818. Epub 2020 Jun 3.'}]}, 'descriptionModule': {'briefSummary': 'Vitamin D has many biological functions. Vitamin D receptors are widely distributed in the male and female reproductive system. Animal experiments have shown that vitamin D deficiency can affect hormone synthesis and gamete formation, reduce sperm motility, and may be related to diseases such as PCOS and endometriosis. Population studies suggest that vitamin D may be related to androgen levels and sperm quality, but whether vitamin D affects the outcome of assisted reproduction is controversial and inconclusive. This study intends to explore whether vitamin D affects the outcome of assisted reproduction through a large sample cohort study.', 'detailedDescription': 'Vitamin D plays an important role in reproduction, while there is high prevalence of vitamin D deficiency. Serum 25(OH)D was categorized according to clinically accepted ranges for vitamin D deficiency (\\<20 ng/mL), insufficiency (20-30 ng/mL), and replete (\\>30 ng/mL).\n\nThis is a retrospective cohort study of about 2000 infertile couples who undergo their first IVF/ICSI and IUI cycle at Reproductive Medicine Center of Peking University Third Hospital. Patients will be excluded if they refuse to be recruited. Serum samples are collected the day when patients first time to Reproductive Medicine Center and were stored at -20℃ until assayed. Life style of patients is collected by questionair. Vitamin D status is measured by assessing circulating levels of 25(OH)D in frozen, never previously thawed serum samples using radioimmunoassay.\n\nThe investigators will comapere the ART outcomes in different groups according to serum 25(OH)D status.\n\nIn female, the primary outcome is clinical pregnancy rates defined as the presence of an intrauterinesac with an embryonic pole demonstrating cardiacactivity at 7 weeks of gestation. Secondary outcomes are quality of embryo, positive hCG rates and live birth rates.\n\nIn male, the primary outcome is semen quality, such as semen volume, sperm concentration, sperm motility, morphologically normal percent and progressive motile spermatozoa percent. Secondary outcomes are clinical pregnancy rates and live birth rates.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'infertile couples', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\ninfertile couples who undergo their first IVF/ICSI and IUI cycle at Reproductive Medicine Center of Peking University Third Hospital.\n\nExclusion Criteria:\n\nrefusing to be recruited.'}, 'identificationModule': {'nctId': 'NCT03804294', 'acronym': 'ART', 'briefTitle': 'Effect of Vitamin D on Outcome of Assisted Reproductive Technology(ART);', 'organization': {'class': 'OTHER', 'fullName': 'Peking University Third Hospital'}, 'officialTitle': 'Effect of Vitamin D on Outcome of Assisted Reproductive Technology(ART)', 'orgStudyIdInfo': {'id': 'Vitamin D and ART'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'vitamin D-ART', 'description': 'Infertile couples who undergo their first IVF/ICSI and IUI cycle in Reproductive Medicin Center of Peking university Third Hosiptal.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '100091', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'XU ZHI', 'role': 'CONTACT', 'email': 'zhixujp@163.com', 'phone': '01082266757'}], 'facility': 'Peking University Third Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'XU ZHI, doctor', 'role': 'CONTACT', 'email': 'zhixujp@163.com', 'phone': '01082266757', 'phoneExt': '01082266757'}, {'name': 'yilu chen, bachelor', 'role': 'CONTACT', 'email': 'yilua_chen@163.com', 'phone': '8601082266752', 'phoneExt': '01082266757'}], 'overallOfficials': [{'name': 'XU ZHI', 'role': 'STUDY_CHAIR', 'affiliation': 'Peking University Third Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking University Third Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'associate professor', 'investigatorFullName': 'Zhi Xu', 'investigatorAffiliation': 'Peking University Third Hospital'}}}}