Assessment of Stress Levels in Consumers Using Ovulation Tests in Order to Conceive
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Cortisol Measurement
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Cortisol Measurement
Time Frame: Twice monthly
Measurement of Urinary Cortisol throughout menstrual cycle
Secondary Outcomes
No secondary outcomes reported