Infertility Clinical Trial
Official title:
Pilot Study Comparing Fertility Monitors: DuoFertility Monitor, LadyComp/Babycomp Monitor and Clearblue Ovulation Tests in Support of FDA Application
Comparative study to determine whether several fertility monitoring products - the DuoFertility monitor, the LadyComp/Babycomp monitor and Clearblue Ovulation tests - are substantially equivalent in performance, and secondarily to determine the appropriateness of labeling information for the DuoFertility monitor.
Status | Completed |
Enrollment | 30 |
Est. completion date | May 2014 |
Est. primary completion date | May 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 44 Years |
Eligibility |
Inclusion Criteria: - Participant is willing and able to give informed consent for participation - Females aged 18 to 44 years - Have a body mass index (BMI) above 19 and below 29 - Regular menstrual cycles, i.e. no greater than 7 days difference between the shortest and longest cycle in the last 6 months - Minimum menstrual cycle 24 days - Maximum menstrual cycle 33 days - Female participants willing to use the 3 fertility monitors for at least 3 cycles. - Willing to fill in regular questionnaires and study diaries Exclusion Criteria: - Women aged younger than 18 years, or older than 44 years - Have a BMI less than 18 or greater than 29 - Any diagnosed systemic illnesses, including but not restricted to thyroid disease, diabetes or inflammatory diseases - Polycystic ovary disease - Endometriosis or other pelvic pathology (including proven tubal disease) - Taking steroids, including oral contraceptives or anti inflammatory drugs |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United Kingdom | Cambridge University Hospitals NHS Foundation Trust | Cambridge | Cambridgeshire |
Lead Sponsor | Collaborator |
---|---|
Cambridge University Hospitals NHS Foundation Trust | Cambridge Temperature Concepts |
United Kingdom,
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