Establishing the Diagnosis Standard and Analysis the Risk Factors of Premature Ovarian Insufficiency in Chinese Women： Multi-center, Prospective,Observational Study
试验速览
- 阶段
- 不适用
- 入组人数
- 50,000
- 试验地点
- 1
- 主要终点
- Menstruation situation
研究概览
简要总结
The study aims to establishing the diagnosis standard of POI and analyzing the risk factors in Chinese women.
详细描述
Premature ovarian insufficiency (POI) is a clinical syndrome defined by loss of ovarian activity before the age of 40 years. The POI guideline development group of ESHRE recommends the following diagnostic criteria: oligo/amenorrhea for at least 4 months and an elevated follicle stimulating hormone (FSH) level >25 mIU/mL on two occasion >4 weeks apart. But there still no diagnosis standard of POI in Chinese.The study aims to establishing the diagnosis standard of POI and analyzing the risk factors in Chinese women.
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
- 12 Years 至 39 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Infertility
- •The length of menstrual cycle longer than 35 days or shorter than/amenorrhea
- •Serum FSH levels ≥10mIU/ml/ serum AMH levels ≤1.0pg/ml/ AFC ≤7, on at least two occasion >4 weeks apart
排除标准
- •Polycystic Ovarian Syndrome
- •other causes of amenorrhea
结局指标
主要结局
Menstruation situation
时间窗: through study completion, an average of 3 months, assessed up to 48 months
the length of the menstrual cycle from date of recruit until the date of study completion or date of twice FSH level \>25mIU/mL, whichever came first.
Change of serum FSH levels
时间窗: through study completion, an average of 3 months, assessed up to 48 months
the serum FSH levels between day 2 to day 5 of menstrual cycle from date of recruit until the date of study completion or date of twice FSH level \>25mIU/mL, whichever came first.
次要结局
- Change of Antral follicle count(through study completion, an average of 3 months, assessed up to 48 months)
- Change of anti-mullerian hormone levels(through study completion, an average of 3 months, assessed up to 48 months)