Libera Efficacy 2 Cycles at Home Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,000
- 试验地点
- 2
- 主要终点
- Difference in pregnancy rates across 2 cycles of use between volunteers trying to conceive in the home setting using (i) COTS, (ii) no intervention.
研究概览
简要总结
Clearblue Connected Ovulation Test System (COTS) has been designed for home use by women who are either planning or trying for a pregnancy. This study will determine the difference in pregnancy rate of female volunteers seeking to get pregnant who use COTS in comparison to those not using an ovulation product to assist with conception.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Actively trying to conceive
- •At least 2 regular consecutive cycles since last pregnancy/ miscarriage/ or since stopping breastfeeding
- •Willing to use their own smartphone for the duration of this study and to download and install the study app
- •Willing to disclose their pregnancy status and provide urine samples to test markers related to pregnancy and fertility
- •Have internet access on their phone for the duration of the study
- •Willing to give informed consent and comply with the investigational procedures
排除标准
- •Currently or previously employed by SPD, Alere, Abbott, Unipath or P&G, or affiliates
- •Has an immediate relative* currently or previously employed by SPD, Alere, Abbott, Unipath or P&G or affiliates
- •There is a reason why the volunteer should not get pregnant e.g. they are taking a medication or have a medical condition which means they should not get pregnant
- •Trying to conceive for more than 6 months (if less than 35 years old) and more than 3 months (if 35 years old or over)
- •Has been diagnosed with Polycystic Ovarian Syndrome (PCOS)
- •Has PCOS symptoms: very irregular cycles, hirsutism
- •Using or has previously used infertility medications or hormone replacement therapy containing hCG or LH (e.g Pregnyl)
- •Are taking clomiphene citrate or other ovulation induction drugs
- •Using any treatment which may affect the menstrual cycle (e.g. the contraceptive pill)
- •Currently pregnant or breastfeeding
- •Peri- or post-menopausal, e.g. experiencing symptoms: Irregular menstrual periods, hot flushes, night sweats, sleep disturbances, and mood swings
- •Have abnormal liver or kidney function
- •Taking medication containing tetracycline
- •Using or undergoing any other medical treatment for fertility such as ovulation drugs, artificial insemination and assisted fertility such as IVF or ICSI
- •Has a phone that is known to be incompatible with COTS
研究组 & 干预措施
COTS
Volunteers will be provided with Clearblue connected Ovulation test system to use during the study period, accortding to the instructions for use.
干预措施: Clearblue Connected Ovulation Test System (Device)
Control
Volunteers will not be provided with Clearblue Connected Ovulation Test System and will be instructed not to use any other ovulation predictions tests during the study period.
结局指标
主要结局
Difference in pregnancy rates across 2 cycles of use between volunteers trying to conceive in the home setting using (i) COTS, (ii) no intervention.
时间窗: 2 months
The difference in pregnancy rates between volunteers trying to conceive in the home setting using (i) COTS (ii) no intervention
次要结局
- Assessment of behaviour of women trying to conceive(2 months)
- Evaluation of women's experience of trying to conceive using COTS compared to not using ovulation tests(2 months)