Clearblue® Advanced Ovulation Test User Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 577
- 试验地点
- 2
- 主要终点
- proportion of users who score the product above average according to the system usability score after 4 weeks of usage
研究概览
简要总结
The Clearblue® Advanced Ovulation Test is designed for home use by women who are either planning or trying for a pregnancy.
The purpose of this protocol is to demonstrate that lay-users representative of the target user population are able to use the product in the intended user environment.
详细描述
The Clearblue Advanced Ovulation Test is designed for home use by women who are trying to get pregnant now or in the near future. It identifies those days in a woman's cycle on which intercourse is most likely to lead to conception.
The product defines three phases of fertility through urine hormone measurement: Low (small chance of conceiving), High (increased chance of conceiving) which is achieved by the detection of a rise in the level of estrone-3-glucuronide and Peak (highest chance of conceiving) which provides an early warning of impending ovulation through detection of the luteinising hormone surge which precedes it by 24 - 36 hours.
This protocol aims to demonstrate the successful usage of the Clearblue Advanced Ovulation Test product by lay-users in the intended environment.
Elements of system usability, product satisfaction and ease of use will be used to assess overall product performance in lay-user hands.
Lay users will be required to user the product according to the instructions for use for a mimimum of 1 complete menstrual cycle after which they will be required to provide feedback on product use.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female Aged 18 to 45 years Trying to conceive, planning to conceive in the next year or interested in using an ovulation testing system.
- •Willing to provide written informed consent to participate in the study. Has menstrual cycles.
排除标准
- •Pregnant, recently pregnant or breastfeeding Diagnosed with Polycystic Ovarian Syndrome Use of hormonal contraception Use of hormone replacement therapy Use of any other medical treatment for fertility such as ovulation drugs, artificial insemination, assisted fertility such as IVF, ICSI Currently or previously employed by SPD, Alere, Unipath or P and G, or affiliates Has an immediate relative currently or previously employed by SPD, Alere, Unipath or P and G or affiliates
研究组 & 干预措施
ovulation test use
All voluteers will receive device for use according to instructions
干预措施: ovulation test use (Diagnostic Test)
结局指标
主要结局
proportion of users who score the product above average according to the system usability score after 4 weeks of usage
时间窗: 4 weeks
≥95% of volunteers score 68 or higher on the usability scale after 4 weeks of usage or at the point of withdrawal from the study
次要结局
- level of lay-user interaction with the product(4 weeks)
- agreement between lay-user interpretation of the test result and the test result as stored in the users account(4 weeks)
- Within and between volunteer experience of using the product(4 weeks)
- Product ease of use and comprehension of instructions for use(4 weeks)