Longitudinal Investigation-Fertility and the Environment

纵向调查-生育率与环境

• 批准号: 7212380
• 负责人: germaine louis
• 金额: --
• 依托单位: EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/7212380
• 关键词: blood tests; chlorohydrocarbon insecticide; clinical research; environmental contamination; environmental exposure; epidemiology; fertility; halobiphenyl /halotriphenyl compound; hormone regulation /control mechanism; human subject; lifestyle; longitudinal human study; nicotine; phytoestrogens; pregnancy; pregnancy tests; reproductive development; sperm analysis; stress; urinalysis

The purpose of the LIFE Study is to assess the impact of environmental factors, broadly defined to include lifestyle factors, on human reproduction and development. The LIFE Study is consistent with the mission of the National Institute of Child Health and Human Development that includes conducting basic, clinical and epidemiologic research focusing on factors and processes associated with human reproduction and development thereby, ensuring the birth of healthy infants capable of reaching full adult potential unimpaired by physical or mental disabilities. This study will assess the relation between select environmental factors and human fecundity and fertility. This research proposes to recruit and retain 800 couples interested in becoming pregnant and willing to participate in a longitudinal study. Couples will be selected from geographic regions that were chosen from peer reviewed competitive proposals. Fecundity will be measured by the time required for the couples to achieve pregnancy, while fertility will be measured by the ability of couples to have a live born infant. Infertility will be recognized for couples unable to conceive within 12 months of trying. The study?s primary environmental exposures include: organochlorine pesticides; polychlorinated biphenyls; polybrominated diphenyl ethers; metals; perfluorinated compounds; cotinine; and phytoestrogens. A growing body of literature suggests these compounds may exert adverse effects on human reproduction and development; however, definitive data are lacking especially for sensitive endpoints. Couples will participate in a 25-minute baseline interview and be instructed in the use of home fertility monitors and pregnancy kits for counting the time required for pregnancy and detecting pregnancy. Blood and urine samples will be collected at baseline from both partners of the couple for measurement of the environmental exposures. Two semen samples from male partners and two saliva samples from female partners also will be requested. Semen samples will be used to globally assess male fecundity as measured primarily by sperm concentration and morphology. Saliva samples will be used for the measurement of cortisol levels as a marker of stress among female partners so that the relation between environmental factors, stress and human reproduction can be assessed. The findings will provide valuable information regarding the effect of environmental contaminants on sensitive markers of human reproduction and development, filling critical data gaps. Moreover, these environmental exposures will be analyzed in the context of other lifestyle exposures such as use of cigarettes and alcohol, consistent with the manner in which human beings are exposed.

LIFE研究的目的是评估环境因素（广义上包括生活方式因素）对人类生殖和发育的影响。LIFE研究符合国家儿童健康和人类发展研究所的使命，其中包括开展基础、临床和流行病学研究，重点关注与人类生殖和发展有关的因素和过程，从而确保出生的健康婴儿能够充分发挥成人潜力，不受身体或精神残疾的影响。 本研究将评估选定的环境因素与人类生殖力和生育力之间的关系。这项研究计划招募和保留800对有兴趣怀孕并愿意参加纵向研究的夫妇。夫妇将从地理区域中选出，这些地理区域是从同行评审的竞争性提案中选出的。生育力将以夫妇怀孕所需的时间来衡量，而生育力将以夫妇生育活产婴儿的能力来衡量。不孕症将被确认为夫妇无法怀孕的12个月内尝试。书房？环境署的主要环境接触包括：有机氯农药、多氯联苯、多溴二苯醚、金属、全氟化合物、可替宁和植物雌激素。越来越多的文献表明，这些化合物可能对人类生殖和发育产生不利影响;然而，缺乏确切的数据，特别是敏感终点。夫妇将参加一个25分钟的基线访谈，并指导使用家庭生育监测器和怀孕工具包，以计算怀孕所需的时间和检测怀孕。将在基线时从夫妇双方采集血液和尿液样本，用于测量环境暴露。男性伴侣的两份精液样本和女性伴侣的两份唾液样本也将被要求。精液样本将用于全面评估男性生育力，主要通过精子浓度和形态进行测量。唾液样本将用于测量皮质醇水平，作为女性伴侣之间压力的标志，以便评估环境因素、压力和人类生殖之间的关系。 研究结果将提供有关环境污染物对人类生殖和发育敏感标志物影响的宝贵信息，填补关键数据空白。此外，这些环境暴露将在其他生活方式暴露的背景下进行分析，如使用香烟和酒精，与人类暴露的方式一致。