NCT04065464已完成不适用
TRACY - Track My Cycle
Center for Epidemiology and Health Research, Germany1 个研究点 分布在 1 个国家目标入组 303 人开始时间: 2019年7月3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
- 303
- 试验地点
- 1
- 主要终点
- Fine-tuning Ava algorithm
研究概览
简要总结
The primary aim of the pilot study is to collect data for the fine-tuning and evaluation of the Ava algorithm. Secondary outcomes are the estimation of the accuracy in detecting the fertility status of each cycle day.
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 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Aged between 18 and 40 at the time of admission
- •Not pregnant and no pregnancy wish during the pilot study period
- •Have a regular sleep pattern (sleep at least four hours per night and not working nightshift)
- •Have regular menstrual cycles
排除标准
- •Pregnant at study admission
- •Currently breastfeeding or have breastfed in the past 6 months before study admission
- •Currently using hormonal contraception or hormonal medication
- •Health-related conditions that may affect menstrual cycle length and variability (e.g. PCOS, menopause, thyroid dysfunction)
- •Unable to understand study instructions and/or not able to understand English or German
- •More than one international overseas travel per month
- •Unwilling to sign the ICF.
结局指标
主要结局
Fine-tuning Ava algorithm
时间窗: 5 months
Number of days within a menstrual cycle that are correctly predicted as 'fertile' by the Ava algorithm. Number of study participants who have their 'fertile window' accurately predicted by the Ava AG app.
次要结局
未报告次要终点
研究者
Clare Barnett, MBBS (Hons) MPH
Director of Project Management, Principal Investigator
Center for Epidemiology and Health Research, Germany
研究点 (1)
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