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中文摘要
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叶酸和锌补充试验(FAZST)是一项多中心、双盲、随机安慰剂对照试验,旨在评估寻求辅助生殖的夫妇的男性伴侣中叶酸和锌补充剂对精液质量和活产的影响。男性受试者被随机平均(1:1)接受活性研究补充剂(5 mg叶酸和30 mg元素锌组合)或匹配的安慰剂。研究干预从随机化开始持续6个月,男性受试者在基线、2、4和6个月时完成亲自研究访视,包括血液、尿液和精液采集。女性伴侣提供基线生物标本和问卷调查数据,通过图表摘要跟踪临床结局。试验招募于2017年12月完成,共有2372对夫妇入组。饮食,运动和生活方式(IDEAL)生育力研究的影响涉及对女性伴侣的子集进行额外的详细随访。 一个大型的生物标本库可用于分析,并为测试多种假设提供了一个很好的平台。本任务订单用于分析FAZST/IDEAL研究中储存的生物标本。本任务订单的工作是测量锌和叶酸代谢标志物、炎症标志物、异前列腺素、内分泌系统标志物和代谢标志物,这将使DIPHR能够结合FAZST/IDEAL研究中已经收集的大量数据回答新的研究问题
英文摘要
The Folic Acid and Zinc Supplementation Trial (FAZST) is a multi-center, double-blind, randomized placebo-controlled trial to assess the effects of follc acid and zinc supplementation among male partners of couples seeking assisted reproduction, on the trial's primary outcomes of semen quality and live birth. Male participants were randomized equally (1:1) either to active study supplement (combined 5 mg folic acid and 30 mg elemental zinc) or to matching placebo. The study intervention continued for 6 months from randomization, and male participants completed in-person study visits, which included blood, urine, and semen collection, at baseline, 2, 4, and 6 months. Female partners provided biospecimens at baseline and questionnaire data, and clinical outcomes were followed through chart abstraction. Trial recruitment was completed in December 2017, with a total of 2372 couples enrolled. The Impact of Diet, Exercise and Lifestyle (IDEAL) Fertility Study involves additional detailed follow-up on a subset of the female partners. A large biospecimen repository is available for analysis and offers a good platform for testing multiple hypotheses. This task order is for the analysis of stored biospecimens in the FAZST/IDEAL studies. The work of this task order to measure zinc and markers of folate metabolism, inflammatory markers, lsoprostanes, endocrine system markers, and metabolic markers will allow DIPHR to answer novel research questions in conjunction with the extensive data already collected in the FAZST/IDEAL studies
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IDIQ BASE BIOMEDICAL ASSAY LABORATORY FOR THE DIVISION OF POPULATION HEALTH RESEARCH - PROJECT TRACKING AND CONSULTATION
  • 批准号:
    10905961
  • 项目类别:
  • 资助金额:
    $2.19万
  • 财政年份:
    2022
  • 负责人:
    MICHAEL TSAI
  • 依托单位:
IDIQ BASE BIOMEDICAL ASSAY LABORATORY FOR THE DIVISION OF POPULATION HEALTH RESEARCH - PROJECT TRACKING AND CONSULTATION
  • 批准号:
    10703545
  • 项目类别:
  • 资助金额:
    $2.16万
  • 财政年份:
    2022
  • 负责人:
    MICHAEL TSAI
  • 依托单位:
COLLABORATIVE PERINATAL PROJECT IN OBESITY GENOME-WIDE ASSOCIATION STUDIES
  • 批准号:
    10670539
  • 项目类别:
  • 资助金额:
    $219.44万
  • 财政年份:
    2022
  • 负责人:
    MICHAEL TSAI
  • 依托单位:
B WELL MOM FATTY ACID PROFILE
  • 批准号:
    10349984
  • 项目类别:
  • 资助金额:
    $1.11万
  • 财政年份:
    2021
  • 负责人:
    MICHAEL TSAI
  • 依托单位:
海外基金