Comparison of DuoFertility, LadyComp/BabyComp and Clearblue Monitors
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ClinicalTrials.gov Identifier: NCT01364935
Recruitment Status :
First Posted : June 3, 2011
Last Update Posted : June 25, 2014
Cambridge University Hospitals NHS Foundation Trust
Cambridge Temperature Concepts
Information provided by (Responsible Party):
Joanne Outtrim, Cambridge University Hospitals NHS Foundation Trust
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.
Condition or disease
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.
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Ages Eligible for Study:
18 Years to 44 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Female participants trying to conceive, with regular menstrual cycles.
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
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