跳至主要内容
临床试验/NCT04068428
NCT04068428已完成不适用

Reproductive Health of Couples of Childbearing Age: a Community Based Prospective Cohort Study

Guangzhou Women and Children's Medical Center4 个研究点 分布在 1 个国家目标入组 2,313 人开始时间: 2019年7月26日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
2,313
试验地点
4
主要终点
Time to pregnancy

研究概览

简要总结

This community based prospective cohort study was established to investigate the fecundability of couples of childbearing age. Data are collected regarding age, body mass index, education, menstrual regularity as well as childbearing history. Results of routine examination of leucorrhea, blood glucose, liver function of the female spouse, and semen analysis of the male spouse are obtained from the National Free Pre-conception Check-up Projects (NFPCP) in China. Couples recruited will be followed every 6 months for at least 1 year, and their time to pregnancy as well as behavior of seeking medical care would be recorded. Blood sample and/or information of antral follicle count would be collected from participants who fail to conceive after 12 months of attempts.

详细描述

Infertility is a heavy burden on families, with important implications for individuals and public health. In the last decades, the trend of delaying marriage and childbearing has further exacerbated the burden of infertility. From February 2010 to November 2011, a large-scale population-based cross-sectional study was conducted in northern and eastern China. It was reported that the overall prevalence of infertility was 15.5% among women 'at risk' of pregnancy, and 25.0% among women attempting to become pregnant in China. The prevalence of infertility was surprisingly high and aroused our great attention. To further explore the fecundability and associated risk factors in current China, this community based prospective cohort study was established. Recruitment will be performed at cites of National Free Pre-conception Check-up Projects (NFPCP). Besides of the information of sociodemographic characteristics and childbearing history of couples, their results of check-ups will also be obtained. By regular follow-ups, valid data of time to pregnancy will be collected. A prospective cohort would provide an opportunity to reveal the incidence of infertility, and explore the underlying risk factors of infertility, as well as the demand of assisted reproductive technology.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Couples who finish the national free pre-conception check-up
  • Couples who agree to receive follow-ups every half year for at least 1 year

排除标准

  • 未提供

结局指标

主要结局

Time to pregnancy

时间窗: From date of recruitment until the date of last menstrual period when conceived, assessed up to 1 year

Assessed by calculate the intervals between last menstrual period when conceived and the timing of termination of contraception.

次要结局

  • Prevalence of infertility(After 1 year of follow-up)

研究者

发起方
Guangzhou Women and Children's Medical Center
申办方类型
Other
责任方
Principal Investigator
主要研究者

Zehong Zhou

Principal Investigator

Guangzhou Women and Children's Medical Center

研究点 (4)

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