Home Ovulation Test One Cycle at Home Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 121
- 试验地点
- 1
- 主要终点
- Device usability
研究概览
简要总结
This study will assess the usability of a Home Ovulation Test when used at home by lay-users seeking to conceive.
详细描述
This study will assess the ease of use of a Home Ovulation Test when used by lay-users for one cycle in their home environment. The home ovulation test to be used in the study is a visual home ovulation test used to detect luteinising hormone (LH) in urine to identify when ovulation is imminent.
A sample size of 120 volunteers (minimum) will provide adequate information for assessing the usability of the home ovulation test. Usability of the test will be assessed through a questionnaire completed at the end of the study.
This observational study will be conducted remotely and volunteers representative of the intended user (lay-users) will be recruited.
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 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Aged 18 to 45 years
- •Seeking to conceive
- •Willing to give informed consent and comply with the investigational procedures
排除标准
- •Taking medication, or has known condition which means they should not get pregnant.
- •Currently pregnant or breastfeeding
- •Used the test within the last six months
- •Currently or previously employed by SPD, Abbott, Alere, Unipath, P&G or affiliates
- •Has an immediate* relative currently or previously (within past 5 years) employed by Swiss Precision Diagnostics (SPD), Abbott, Alere, Unipath or P&G, or affiliates
- •*Immediate relatives are defined as parents, children, siblings or partner/spouse
- •Is a qualified or trainee healthcare professional (HCP)
- •Has professional experience of using dipstick type tests or lateral flow devices
- •Using any treatment which may affect the menstrual cycle (e.g. contraceptive pill)
- •Using infertility medications or hormone replacement medications containing Luteinising Hormone (LH) or human Chorionic Gonadotrophin (hCG) (e.g. Pregnyl®)
- •Using or undergoing any other medical treatment for fertility such as ovulation drugs, artificial insemination and assisted fertility such as In vitro fertilization (IVF) or Intracytoplasmic sperm injection (ICSI)
- •Peri-or post-menopausal, e.g. experiencing symptoms: irregular menstrual periods, hot flushes, night sweats, sleep disturbances and/or moods swings
- •Has been diagnosed with polycystic ovarian syndrome (PCOS)
- •Has PCOS symptoms e.g. very irregular cycles, hirsutism
结局指标
主要结局
Device usability
时间窗: One menstrual cycle, average 28 days
The usability of the home ovulation test when used at home by volunteers seeking to conceive scored on a 7 point Likert scale where 1 is the lowest (most negative) score and 7 is the highest (most positive) score.
次要结局
未报告次要终点