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Completed

NCT Number: NCT03908697

Quantum Natural Family Planning Pilot

•The Pilot study will involve current Marquette Method users who own and use a ClearBlue Fertility monitor and who will be asked to simultaneously use the Mira monitor for the sake of comparing the two devices to monitor the menstrual cycle.

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Key information

Conditions

Fertility Disorders

Age range

18 year–42 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Deer Valley family Medicine Clinic

Calgary, Alberta, T2J6W5, Canada

About this study

  • The Mira fertility monitoring system (www.miracare.com) is a new home-use hormone tracking device with the ability to quantitatively measure reproductive hormones in the urine but is also synced to a smart phone App that provides a graphic representation of the hormonal levels throughout a menstrual cycle.
  • The Mira monitor will be compared to the ClearBlue Fertility Monitor for its ease of use, satisfaction, and accuracy.
  • The Mira hormonal monitor and App system has not been tested for its use in Natural Family Planning (NFP).
  • The Pilot study will involve current Marquette Method users who own and use a ClearBlue Fertility monitor and who will be asked to simultaneously use the Mira monitor for the sake of comparing the two devices.
  • Female participants invited to participate will need to meet the following criteria:
  • Age 18 to 42 years
  • Menstrual cycle ranging between 21-42 days
  • At least 3 cycles after cessation of breastfeeding
  • Not currently on medications that affect ovulation and 3 months prior
  • Not currently pregnant or breastfeeding
  • No known fertility problems
  • Not planning on achieving pregnancy during the 3 menstrual cycles of the study

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • • Menstrual cycle ranging between 21-42 days
  • At least 3 cycles after cessation of breastfeeding

Exclusion criteria

  • • Not currently on medications that affect ovulation and 3 months prior
  • Not currently pregnant or breastfeeding
  • No known fertility problems
  • Not planning on achieving pregnancy during the 3 menstrual cycles of the study

Treatment and study plan

Mira monitor comparison to ClearBlue monitor

Device

Testing first morning urine with hormone test sticks at home

Primary outcomes

  1. Day of the estimated beginning of the fertile phase of the menstrual cycle:

    Time frame: 3 months

    First day of the estimated fertile phase as measured by Clearblue Fertility Monitor First day of the estimated fertile phase as measured by the MIRA Fertility Monitor

  2. Day of the estimated peak of the fertile phase of the menstrual cycle:

    Time frame: 3 months

    Peak day of the estimated fertile phase as measured by the Clearblue Fertility Monitor Peak day of the estimated fertile phase as measured by the MIRA Fertility Monitor

  3. Day of the estimated end of the fertile phase of the menstrual cycle:

    Time frame: 3 months

    Last day of the estimated fertile phase as measured by the Clearblue Fertility Monitor Last day of the estimated fertile phase as measured by the MIRA Fertility Monitor

Secondary outcomes

  1. Satisfaction and Ease of Use of a Electronic Fertility Monitor:

    Time frame: 3 months

    Measured by the modified 8 item Severy Satisfaction Scale

    Total score rages from 8 - 24 with 24 being the highest satisfaction

Sponsors and collaborators

Lead sponsor

Quanovate Tech Inc.

Industry

Registry information

Official study title

Comparison of Two Hormonal Fertility Monitors for Use in Natural Family Planning

Acronym: QNFP

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Apr 9, 2019
Registry last updated
Mar 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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