Establishing of an Early Warming System of Premature Ovarian Insufficiency
试验速览
- 阶段
- 不适用
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- the change of menstruation situation
研究概览
简要总结
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. Some clinicians and researchers proposed that POI was a progressive disease and there were three stages of POI: occult POI, biochemical POI, overt POI. However, there is lack of reliable indicators to assess the different stages of POI. The present study is to explore the change of menstruation condition, basal follicle-stimulating hormone, anti-müllerian hormone and antral follicle count during the development of POI, and whether those marks can assess the different stages of POI.
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 40 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Serum FSH levels ≥10mIU/ml/ serum AMH levels ≤1.0pg/ml/ AFC ≤5, 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
the change of menstruation situation
时间窗: Every 3 months from date of recruit until the date of study completion, assessed up to 48 months
Menstrual cycle
the change of serum follicle-stimulating hormone levels
时间窗: Every 3 months from date of recruit until the date of study completion, assessed up to 48 months
the serum FSH levels between day 2 to day 5 of menstrual cycle
the change of serum anti-mullerian hormone levels
时间窗: Every 3 months from date of recruit until the date of study completion, assessed up to 48 months
the serum anti-mullerian hormone levels between day 2 to day 5 of menstrual cycle
the change of antral follicle count
时间窗: Every 3 months from date of recruit until the date of study completion, assessed up to 48 months
Antral follicle count between day 2 to day 5 of menstrual cycle
次要结局
未报告次要终点