NCT01084304

Assessment of Stress Levels in Consumers Using Ovulation Tests in Order to Conceive

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 150 (estimated)
• Sponsor: SPD Development Company Limited · Industry
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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.

Conditions

• Stress

Timeline

• Start date: 2010-02-01
• Primary completion: 2011-06-01
• Completion: 2011-06-01
• First posted: 2010-03-10
• Last updated: 2017-03-24

Locations

1 site across 1 country: United Kingdom