ORGANOPHOSPHATE PESTICIDES AND HUMAN REPRODUCTIVE HEALTH

描述：(改编自《调查者摘要》)本研究设计 招募并预期跟随一群妇女和她们的丈夫去 评估接触有机磷(OP)农药对不良反应的影响 男性和女性在农业工人中的生殖结果。已婚 目前在安庆市海口镇工作的20-34岁的不吸烟妇女， 他们已经获得了生育许可，并将尝试 在研究过程中怀孕的人将有资格参加研究。 生殖终点将包括(1)精液参数(浓度、总量 计数、运动、进展和形态)，(2)月经失调 (月经过少、闭经、多经、经期出血、经期延长 月经出血、痛经、月经不调)；(3)月经变化 在激素模式中，包括雌激素排泄减少(REE)，无排卵， 女性黄体期异常(ALP)和卵泡期异常(AFP) 男性促黄体生成素、促卵泡刺激素、促甲状腺激素、单核细胞生成素、抑制素-B和睾酮异常； 受精性；以及(5)妊娠结局，包括自然流产， 早产、低出生体重和宫内发育迟缓。之后 登记，面试官将管理之前验证过的调查问卷 给妇女和她们的丈夫收集基线信息 社会人口、环境、职业和个人协变量。精液 样本将由训练有素的技术人员在注册时获取，并再次在四个月内 几个月后。每个女人都会记下她的月经信息， 环境暴露和饮食摄入量。每天的尿样将会是 从每名女性受试者身上收集最多一年或直到怀孕 发生。测定尿PDG、EIC、LH、FSH和hCG以确定异常情况 内分泌模式与亚临床妊娠。一旦女人怀孕了， 将对她进行跟踪调查，以了解其妊娠结局。 以及婴儿出生的医院记录。广泛的暴露评估 将在整个随访期内进行，因此，剂量反应 可以建立关系。所有参与者将保持每日接触 日记。尿样将在选定的暴露条件下进行代谢物检测。 几天。一部分参与者将被研究用于个人空气监测和 尿液代谢物系列分析以验证暴露日记和尿液 代谢物分析。调查人员表示，这项拟议的研究有几个 优势：(1)将在范围广泛的人群中进行 有机磷农药暴露；(2)暴露将被很好地描述； (3)每名妇女和她的丈夫将被同时研究； 前瞻性研究设计可以消除某些缺陷或潜在的偏见 以前的回顾研究；(5)受孕时间和自然流产 将用改进的特异性hCG检测方法进行评估，该方法可以检测到 植入后几天内怀孕；(6)最近开发的生物标志物， 包括尿激素分析和FISH方法，将应用于 研究；(7)将测试基因与环境的相互作用；(8) 中国比美国低得多；(9)人口拥有 检验提出的假设的独特特征，即一个稳定的 劳动力、不吸烟群体和出色的遵从率。

DESCRIPTION: (Adapted from the Investigator's Abstract) This study is designed to recruit and prospectively follow a cohort of women and their husbands to assess the effects of exposure to organophosphate (OP) pesticides on adverse reproductive outcomes in both men and women in agricultural workers. Married never-smoking women age 20-34 who currently work in Haikou Township, Anqing, who have obtained permission to have a child, and who will be attempting to become pregnant over the course of the study will be eligible for the study. Reproductive endpoints will include (1) semen parameters (concentration, total count, motility, progression and morphology), (2) menstrual disorders (oligomenorrhea, amenorrhea, polymenorrhea, intermenstrual bleeding, prolonged menstrual bleeding, dysmenorrhea, and irregular menstruation); (3) alterations in hormone patterns including reduced estrogen excretion (REE), anovulation, abnormal luteal phase (ALP), and abnormal follicular phase (AFP) in women and abnormalities of LH, FSH, TSH, SHBG, inhibin-B and testosterone in men; (4) fecundability; and (5) pregnancy outcomes including spontaneous abortion, preterm delivery, low birth weight and intrauterine growth retardation. After enrollment, interviewers will administer a previously validated questionnaire to the women and their husbands to collect baseline information on sociodemographic, environmental, occupational, and personal covariates. Semen samples will be obtained by trained technicians at enrollment and again four months later. Each woman will keep a diary of her menstrual information, environmental exposures, and dietary intake. Daily urine samples will be collected from each female subject for up to one year or until a pregnancy occurs. Urinary PdG, EIC, LH, FSH and hCG will be measured to identify abnormal endocrine patterns and subclinical pregnancy. Once a woman becomes pregnant, she will be followed for pregnancy outcomes obtained from a follow-up survey and hospital records where the baby is delivered. Extensive exposure assessment will be conducted throughout the follow-up period and, therefore, dose-response relationships can be established. All participants will keep daily exposure diaries. Urine samples will be measured for metabolites on selected exposure days. A subset of participants will be studied for personal air monitoring and serial analysis of urine metabolites to validate the exposure diary and urine metabolite assay. The investigators state that the proposed study has several strengths: (1) it will be conducted in a population with a broad range of organophosphate pesticide exposure; (2) exposure will be well-characterized; (3) each woman and her husband will be studied simultaneously; (4) the prospective study design can eliminate certain flaws or potential biases in previous retrospective studies; (5) time to conception and spontaneous abortion will be evaluated with the improved specific hCG assay, which can detect pregnancy within a few days of implantation; (6) recently-developed biomarkers, including urinary hormone assays and FISH methods, will be applied to the study; (7) gene-environment interactions will be tested; (8) the field cost in China is much lower than that in the U.S.; and (9) the population possesses unique characteristics for examining the proposed hypothesis, i.e., a stable workforce, a non-smoking group and excellent compliance rates.