Continuous Sample Collection Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 558
- 试验地点
- 1
- 主要终点
- Collection of urine samples during conception cycle
研究概览
简要总结
This study will provide urine cycles from both pregnant and not pregnant volunteers to maintain the SPD sample bank.
Study volunteers, seeking to conceive will be provided with Clearblue Ovulation product to help them pinpoint their most fertile time and aid conception. All volunteers will provide daily early morning urine samples throughout the study period and keep a study diary of menses and pregnancy test results for 1 menstrual cycle.
Urine samples will be received in the clinical laboratory and aliquoted into 2.25ml amounts at stored at -80˚C until required.
The study will also gather optional information from volunteers regarding a woman's general health and stress levels when trying to conceive. This will be used to study the relationship between general health, stress and conception.
详细描述
This study will provide urine cycles from both pregnant and not pregnant volunteers to maintain the SPD sample bank.
Study volunteers, seeking to conceive will be recruited to the study after providing written informed consent. All volunteers will be provided with Clearblue Ovulation product to help them pinpoint their most fertile time and aid conception and be required to collect daily early morning urine samples throughout the study until pregnancy is conformed or their next menstrual period starts. Volunteers will be required to keep a daily diary of menses, sample collection and pregnancy test results. The study will last for 1 menstrual cycle.
Urine samples will be received in the clinical laboratory will be tested for the presence of hormones related to pregnancy and fertility, then aliquoted into 2.25ml amounts at stored in the SPD BioBank at -80˚C until required for product development or evaluation .
The study will also gather optional information from volunteers regarding a woman's general health and stress levels when trying to conceive. This will be used to study the relationship between general health, stress and conception.
Demographic data will be summarised. No statistical analysis will be conducted on the data.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- 是
入选标准
- •Females aged 18-40 years actively trying to conceive
- •At least 2 regular consecutive cycles since last pregnancy/miscarriage/or since stopping breastfeeding
- •Willing to disclose their pregnancy status and provide urine samples.
- •Willing to give informed consent and comply with the investigational procedures.
排除标准
- •Conditions that contraindicated pregnancy
- •Taking medication, or has known condition which means they should not get pregnant.
- •Currently pregnant or breastfeeding
- •Abnormal liver or kidney function
- •Taking antibiotics containing tetracycline.
- •Previously participated in this study
结局指标
主要结局
Collection of urine samples during conception cycle
时间窗: 2 years
Daily during samples collected throughout the cycle in which conception occurs
次要结局
未报告次要终点