The Clinical Cohort Study of Reproductive Health
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 3,000
- 主要终点
- birth weight
研究概览
简要总结
The study will conduct a multicenter prospective clinical cohort study to collect comprehensive health information and essential specimens from pre-pregnancy to postpartum offspring development. We will combine the reproductive medicine with the big data technologies and cloud computing to explore the key factors which will induce the occurrence the reproductive disorders and effect the health of women and offspring. Based on the discovery of the cohort study, we will construct a prediction model for improvement of ART，optimizing the effectiveness and safety of ART.
详细描述
Safeguarding the health of women and children is an important part of The Healthy China 2030 Plan. Precisely controlling the fertility process will help to improve the quality of national population. Lots of studies have reported that environmental exposure, lifestyle, diet and other factors are related to fertility, female pregnancy and postpartum health, and offspring development. Some studies have found that assisted reproductive technology (ART) represents an increased risk of epigenetic-related diseases or birth defects.
The study will conduct a multicenter prospective clinical cohort study to collect comprehensive health information and essential specimens from pre-pregnancy to postpartum offspring development. We will combine the reproductive medicine with the big data technologies and cloud computing to explore the key factors which will induce the occurrence the reproductive disorders and effect the health of women and offspring. Based on the discovery of the cohort study, we will construct a prediction model for improvement of ART，optimizing the effectiveness and safety of ART.
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
- 20 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Couples undergoing treatment for infertility or getting pregnant naturally and wanting to deliver their babies in study hospitals.
- •Men 22-55 years old
- •Women 20 - 45 years old
排除标准
- •Any individual or couple who is outside of age range .
- •Any couple who don't plan to complete their pregnancy check-up or deliver their babies in study hospitals.
- •Any couples had participated in other clinical studies.
结局指标
主要结局
birth weight
时间窗: 1 day after delivery
Weight of newborns at delivery.
height
时间窗: Change from the date of delivery up to 2 years after delivery
the height of offspring
Incidence of mental diseases and metabolic dysfunction
时间窗: from the date of delivery up to 2 years after delivery
weight
时间窗: Change from the date of delivery up to 2 years after delivery
the weight of offspring
live birth rate
时间窗: 1 day after delivery
Number of women with live births / number of women randomized to the specific group.
次要结局
- clinical pregnancy rate(6 weeks after embryo transfer)
- preterm birth rate(28 gestational weeks to 37 gestational weeks)
- implantation rate(11-12 weeks after embryo transfer)
- neonatal complication rate(1 day after delivery)
研究者
Dan Zhang
Vice president
Women's Hospital School Of Medicine Zhejiang University