Stress
Conditions
Keywords
Pregnancy, Ovulation tests, stress, Wishing to become pregnant
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.
Interventions
None listed
Sponsors
SPD Development Company Limited
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cortisol Measurement | Twice monthly | Measurement of Urinary Cortisol throughout menstrual cycle |
Countries
United Kingdom
Outcome results
None listed