DATA COORDINATING CENTER FOR THE IDEAL FERTILITY STUDY

流行病学处和该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、锻炼和生活方式对生育的影响(理想)研究)，该研究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试验是一项多点双盲区随机安慰剂对照临床试验，旨在评估补充叶酸和硫酸锌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果的影响。这项拟议的倡议是与犹他大学签订的HHSN275201500001C合同下的一份为期16个月的数据支持合同，该合同名为“饮食、锻炼和生活方式对生育的影响：理想的生育研究”。拟议的举措包括对叶酸和锌补充剂试验的女性伙伴采取额外的详细后续行动(包括问卷调查和生物样品收集)，其中将包括一个负责招募和留住女性伙伴的试验协调中心，以及负责全面数据管理和网上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。拟议任务令的目的是提供为期16个月的数据管理支助，在征聘结束前支持这项研究，并提供一份征聘工作的详细报告，这将成为提交供出版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.