Clinical Trials Directory

Trials / Completed

CompletedNCT01364935

Comparison of DuoFertility, LadyComp/BabyComp and Clearblue Monitors

Pilot Study Comparing Fertility Monitors: DuoFertility Monitor, LadyComp/Babycomp Monitor and Clearblue Ovulation Tests in Support of FDA Application

Status
Completed
Phase
Study type
Observational
Enrollment
30 (actual)
Sponsor
Cambridge University Hospitals NHS Foundation Trust · Academic / Other
Sex
Female
Age
18 Years – 44 Years
Healthy volunteers
Accepted

Summary

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.

Detailed description

The investigators plan to recruit 30 women who are currently trying to conceive, and ask them to use the 3 fertility monitors for duration of 3 menstrual cycles. Additionally, during the study the women will be asked to fill in online questionnaires to assess the usability of the monitors. As the spouse is often a critical partner in the purchase decision and compliance, the investigators will also ask the spouse to complete similar online questionnaires.

Conditions

Timeline

Start date
2011-03-01
Primary completion
2014-05-01
Completion
2014-05-01
First posted
2011-06-03
Last updated
2014-06-25

Locations

1 site across 1 country: United Kingdom

Source: ClinicalTrials.gov record NCT01364935. Inclusion in this directory is not an endorsement.