Comparison of DuoFertility, LadyComp/BabyComp and Clearblue Monitors
This study has been completed.
Cambridge Temperature Concepts
Information provided by (Responsible Party):
Joanne Outtrim, Cambridge University Hospitals NHS Foundation Trust
First received: May 31, 2011
Last updated: June 24, 2014
Last verified: June 2014
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.
||Observational Model: Cohort
Time Perspective: Prospective
||Pilot Study Comparing Fertility Monitors: DuoFertility Monitor, LadyComp/Babycomp Monitor and Clearblue Ovulation Tests in Support of FDA Application
| Study Start Date:
| Study Completion Date:
| 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.
|Ages Eligible for Study:
||18 Years to 44 Years
|Genders 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01364935
|Cambridge University Hospitals NHS Foundation Trust
|Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ |
Cambridge University Hospitals NHS Foundation Trust
Cambridge Temperature Concepts
||Cambridge University Hospitals NHS Foundation Trust
No publications provided
ClinicalTrials.gov processed this record on March 26, 2015
||Joanne Outtrim, RN, Cambridge University Hospitals NHS Foundation Trust
History of Changes
|Other Study ID Numbers:
|Study First Received:
||May 31, 2011
||June 24, 2014
||United Kingdom: Research Ethics Committee