Assessment of Stress Levels in Consumers Using Ovulation Tests in Order to Conceive
- Conditions
- Stress
- Registration Number
- NCT01084304
- Lead Sponsor
- SPD Development Company Limited
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 150
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cortisol Measurement Twice monthly Measurement of Urinary Cortisol throughout menstrual cycle
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
SPD Development Company Ltd
🇬🇧Bedford, Bedfordshire, United Kingdom