Comparison of DuoFertility, LadyComp/BabyComp and Clearblue Monitors
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Pilot Study Comparing Fertility Monitors: DuoFertility Monitor, LadyComp/Babycomp Monitor and Clearblue Ovulation Tests in Support of FDA Application|
|Study Start Date:||March 2011|
|Study Completion Date:||May 2014|
|Primary Completion Date:||May 2014 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01364935
|Cambridge University Hospitals NHS Foundation Trust|
|Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ|
|Principal Investigator:||Basil Matta||Cambridge University Hospitals NHS Foundation Trust|