Comparison of DuoFertility, LadyComp/BabyComp and Clearblue Monitors

This study has been completed.
Sponsor:
Collaborator:
Cambridge Temperature Concepts
Information provided by (Responsible Party):
Joanne Outtrim, Cambridge University Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT01364935
First received: May 31, 2011
Last updated: June 24, 2014
Last verified: June 2014
  Purpose

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
Infertility

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

Resource links provided by NLM:


Further study details as provided by 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.

  Eligibility

Ages Eligible for Study:   18 Years to 44 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Female participants trying to conceive, with regular menstrual cycles.

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01364935

Locations
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
Investigators
Principal Investigator: Basil Matta Cambridge University Hospitals NHS Foundation Trust
  More Information

No publications provided

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

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on July 29, 2014