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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 Identifier:
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.


Study Type: Observational
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

Further study details as provided by Joanne Outtrim, Cambridge University Hospitals NHS Foundation Trust:

Enrollment: 30
Study Start Date: March 2011
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
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.

Ages Eligible for Study:   18 Years to 44 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Female participants trying to conceive, with regular menstrual cycles.

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01364935

United Kingdom
Cambridge University Hospitals NHS Foundation Trust
Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
Sponsors and Collaborators
Cambridge University Hospitals NHS Foundation Trust
Cambridge Temperature Concepts
Principal Investigator: Basil Matta Cambridge University Hospitals NHS Foundation Trust
  More Information

Responsible Party: Joanne Outtrim, RN, Cambridge University Hospitals NHS Foundation Trust Identifier: NCT01364935     History of Changes
Obsolete Identifiers: NCT01343199
Other Study ID Numbers: A092165
11/EE/0016 ( Other Identifier: National Research Ethics Committee )
Study First Received: May 31, 2011
Last Updated: June 24, 2014

Additional relevant MeSH terms:
Genital Diseases, Male
Genital Diseases, Female processed this record on May 25, 2017