DATA COORDINATING CENTER FOR THE IDEAL FERTILITY STUDY

理想生育力研究数据协调中心

• 批准号: 9349074
• 负责人: TRACI E CLEMONS
• 金额: $ 11.33万
• 依托单位: THE EMMES COMPANY, LLC
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-09-01 至 2017-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9349074
• 关键词: Address; Blood; Collection; Contracts; Controlled Clinical Trials; Couples; Data; Data Collection; Data Coordinating Center; Double-Blind Method; Epidemiology; Female; Fertility; Fertility Study; Folic Acid; Follicular Fluid; Life Style; Monitor; Online Systems; Paper; Participant; Placebo Control; Placenta; Publications; Quality Control; Questionnaires; Randomized; Recruitment Activity; Reporting; Research; Research Design; Saliva; Seminal fluid; Site; Supplementation; Support Contracts; System; Time; Treatment outcome; Universities; Urine; Utah; Work; Zinc Sulfate; Zinc supplementation; base; data management; demographics; diet and exercise; follow-up; infertility treatment; male; web site

The Epidemiology Branch and Division are currently inviting female partners of participants in the Folic Acid and Zinc Supplementation Trials (FAZST), to participate in a study (the Impact of Diet, Exercise and Lifestyle on Fertility (IDEAL)study) that includes specific and detailed follow-up for the female partners to address these important research questions. The FAZST trial is a multi-site double-blind block randomized placebo-controlled clinical trial to evaluate the effect of folic acid and zinc sulfate supplementation on semen quality and fertility treatment outcomes among male partners of couples seeking fertility treatment. The proposed initiative is a 16 month data supporting contract for the “Impact of Diet, Exercise And Lifestyle on Fertility: The IDEAL Fertility Study” with the University of Utah under contract HHSN275201500001C. The proposed initiative, which includes additional detailed follow-up (both questionnaires and biospecimen collection) to the female partners of the Folic Acid and Zinc Supplementation Trial (FAZST), will involve a Trial Coordinating Center that is responsible for recruitment and retention of the female partners, and the Data Coordinating Center that is responsible for overall data management and the web-based data collection system. The Trial Coordinating Center is a separate scope of work and is a separate non-severable contract. The objective of the proposed task order is to provide data management support for 16 months which will support the study through the end of recruitment, as well as a detailed report of the recruitment efforts which will form the basis of a study design paper to be submitted for publication.

流行病学处和司目前正在邀请叶酸和锌补充试验（FAZST）参与者的女性伴侣参加一项研究（饮食、运动和生活方式对生育能力的影响（IDEAL）研究），该研究包括对女性伴侣进行具体和详细的随访，以解决这些重要的研究问题。FAZST试验是一项多地点双盲区随机安慰剂对照临床试验，旨在评估叶酸和硫酸锌补充剂对寻求生育治疗的男性伴侣精液质量和生育治疗结果的影响。该计划是一项为期16个月的数据支持合同，与犹他大学签订了“饮食、运动和生活方式对生育的影响：理想生育研究”，合同为HHSN275201500001C。拟议的倡议包括对叶酸和锌补充试验（FAZST）的女性合作伙伴进行额外的详细随访（问卷调查和生物标本收集），将涉及一个负责招募和保留女性合作伙伴的试验协调中心，以及负责总体数据管理和基于网络的数据收集系统的数据协调中心。审判协调中心是一个单独的工作范围，是一个单独的不可分割的合同。拟议任务订单的目标是提供为期16个月的数据管理支持，这将支持该研究直至征聘结束，并提供一份关于征聘工作的详细报告，该报告将成为提交出版的研究设计文件的基础。