Assessment of Stress Levels in Consumers Using Ovulation Tests in Order to Conceive
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Cortisol Measurement
研究概览
简要总结
Approximately 150 female volunteers wishing to become pregnant will be recruited via web recruitment from around the UK and randomised 1:1 to receive Clearblue Digital ovulation tests (active arm) or no aid to conception (control arm) for 2 full menstrual cycles. All volunteers will complete study questionnaires and provide a urine sample at designated time points though out the menstrual cycle.
A sub-arm to this study, applied the same protocol to women in an infertility treatment setting; Royal Hallamshire Hospital, Sheffield. Additional exclusion criteria were applied to this cohort; had regular menstrual cycles between 25 and 35 days, and who did not have a diagnosis of bilateral or unilateral tubal blockage, documented anovulation or severe male-factor infertility (with <5 million motile sperm per ejaculate). For this arm, the protocol was reviewed by Sheffield Research Ethics Committee 09/H1308/134.
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
- 是
入选标准
- •Provide written informed consent to participate in the study and agree to comply with study procedures.
- •Has menstrual bleeds.
- •Seeking to become pregnant.
- •Living in UK
排除标准
- •Used hormonal contraception within the last 3 months.
- •Currently undergoing fertility treatment or investigation.
- •Diagnosed as infertile following investigations.
- •Drug or alcohol dependency.
- •history of depression, anxiety or panic attacks
结局指标
主要结局
Cortisol Measurement
时间窗: Twice monthly
Measurement of Urinary Cortisol throughout menstrual cycle
次要结局
未报告次要终点
