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Comparison of DuoFertility, LadyComp/BabyComp and Clearblue Monitors

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by Cambridge University Hospitals NHS Foundation Trust.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Cambridge Temperature Concepts
Information provided by:
Cambridge University Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT01364935
First received: May 31, 2011
Last updated: June 1, 2011
Last verified: January 2011
History of Changes

May 31, 2011
June 1, 2011
March 2011
July 2011   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT01364935 on ClinicalTrials.gov Archive Site
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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.

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.
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

Female participants trying to conceive, with regular menstrual cycles.
Infertility
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
30
July 2011
July 2011   (final data collection date for primary outcome measure)

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
Female
18 Years to 44 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01364935
A092165, 11/EE/0016
No
Dr. Basil Matta, Cambridge University Hospitals NHS Foundation Trust
Cambridge University Hospitals NHS Foundation Trust
Cambridge Temperature Concepts
Principal Investigator: Basil Matta Cambridge University Hospitals NHS Foundation Trust
Cambridge University Hospitals NHS Foundation Trust
January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP