DATA COORDINATING CENTER FOR THE IDEAL FERTILITY STUDY

流行病学分支和司目前正在邀请叶酸和锌补充试验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力的影响研究），其中包括对女性伴侣进行具体和详细的后续行动，以解决这些重要的研究问题。FAZST试验是一项多中心双盲区组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夫妇的男性伴侣的精液质量和生育治疗结局的影响。该计划是一项为期16个月的数据支持合同，用于与犹他州大学签订的“饮食、运动和生活方式对生育的影响：理想生育研究”，合同编号为HHSN 275201500001 C。拟议的举措包括对叶酸和锌补充试验（FAZST）的女性伴侣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伴侣的试验协调中心，以及负责整体数据管理和基于网络的数据收集系统的数据协调中心。试验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。拟议任务订单的目的是提供为期16个月的数据管理支持，以支持研究直至招募结束，并提供招募工作的详细报告，该报告将构成提交发表的研究设计文件的基础。

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.