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.

目前，流行病学分支和分裂被邀请参加叶酸和锌补充试验（FAZST）参与者的女性伴侣，以参与一项研究（饮食，运动和生活方式对生育能力（理想）研究的影响，其中包括针对女性伴侣解决这些重要研究问题的特定和详细的随访。 FAZST试验是一项多站点的双盲块随机安慰剂对照临床试验，以评估叶酸和硫酸锌补充对寻求生育治疗的夫妻伴侣的精液质量和生育治疗结果的影响。拟议的倡议是一项16个月的数据支持合同，以“饮食，运动和生活方式对生育能力的影响：理想的生育研究”与犹他大学合同根据合同HHSN2752015001C。拟议的计划包括向叶酸和补充锌补充试验（FAZST）的女性合作伙伴（FAZST）的女性伴侣进行的其他细节后续行动（问卷和生物素质收集），将涉及一个试验协调中心，该中心负责负责女性合作伙伴的招聘和保留女性合作伙伴，以及负责负责总体数据管理数据管理和网络数据管理和网络数据管理和网络数据管理和网络数据管理和网络数据管理和网络数据管理系统。试验协调中心是独立的工作范围，是一项独立的非独立合同。拟议的任务订单的目的是提供16个月的数据管理支持，这将通过招聘结束，并提供招聘工作的详细报告，这些报告将构成要提交的研究设计论文的基础。