NCT03131388已完成不适用
Clinical Performance Evaluation of AMH Assay
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 277
- 试验地点
- 13
- 主要终点
- Measurement of AMH as an aid for fertility assessment
研究概览
简要总结
The Access AMH Assay is an in vitro diagnostic assay intended as an aid for fertility assessment. The purpose of the study is to evaluate the clinical performance of the Access AMH Assay in the intended use population.
详细描述
same as brief summary
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 21 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •≥ 21 and < 46 years of age
- •Regular menstrual cycle
- •Both ovaries present
排除标准
- •Evidence of PCOS
- •Confirmed ovarian endometrioma
- •Ovarian surgery prior to enrollment
- •Being treated for cancer
- •Hormonal contraceptive use prior to enrollment
- •Currently pregnant
结局指标
主要结局
Measurement of AMH as an aid for fertility assessment
时间窗: Day 2 to 4 of menstrual cycle
Comparison of AMH levels in women at different levels of AFC to aid in assessing ovarian reserve
次要结局
未报告次要终点
研究者
研究点 (13)
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