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

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 Overview

• Status: Completed
• Conditions: Infertility

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.

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• United Kingdom
  • Cambridgeshire
    • Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
      • Cambridge University Hospitals NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 44 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Female participants trying to conceive, with regular menstrual cycles.

Description

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

Study Plan

How is the study designed?

Collaborators and Investigators

• Sponsor: Cambridge University Hospitals NHS Foundation Trust
• Collaborators: Cambridge Temperature Concepts
• Investigators: Principal Investigator: Basil Matta, Cambridge University Hospitals NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Actual): May 1, 2014
• Study Completion (Actual): May 1, 2014

Study Registration Dates

• First Submitted: May 31, 2011
• First Submitted That Met QC Criteria: June 1, 2011
• First Posted (Estimate): June 3, 2011

Study Record Updates

• Last Update Posted (Estimate): June 25, 2014
• Last Update Submitted That Met QC Criteria: June 24, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infertility
• Other Study ID Numbers: A092165; 11/EE/0016 (Other Identifier: National Research Ethics Committee)