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Comparison of DuoFertility, LadyComp/BabyComp and Clearblue Monitors

Sponsor
Cambridge University Hospitals NHS Foundation Trust (Other)
Overall Status
Completed
CT.gov ID
NCT01364935
Collaborator
Cambridge Temperature Concepts (Industry)
30
Enrollment
1
Location
38
Duration (Months)
0.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    30 participants
    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 :
    Mar 1, 2011
    Actual Primary Completion Date :
    May 1, 2014
    Actual Study Completion Date :
    May 1, 2014

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      18 Years to 44 Years
      Sexes Eligible for Study:
      Female
      Accepts Healthy Volunteers:
      Yes
      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

      Locations

      Site City State Country Postal Code
      1 Cambridge University Hospitals NHS Foundation Trust Cambridge Cambridgeshire United Kingdom CB2 0QQ

      Sponsors and Collaborators

      • Cambridge University Hospitals NHS Foundation Trust
      • Cambridge Temperature Concepts

      Investigators

      • Principal Investigator: Basil Matta, Cambridge University Hospitals NHS Foundation Trust

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      Joanne Outtrim, RN, Cambridge University Hospitals NHS Foundation Trust
      ClinicalTrials.gov Identifier:
      NCT01364935
      Other Study ID Numbers:
      • A092165
      • 11/EE/0016
      • NCT01343199
      First Posted:
      Jun 3, 2011
      Last Update Posted:
      Jun 25, 2014
      Last Verified:
      Jun 1, 2014
      Additional relevant MeSH terms:
      Infertility

      Study Results

      No Results Posted as of Jun 25, 2014