Quantum Natural Family Planning Pilot (QNFP)

March 21, 2025 updated by: Thomas Bouchard, MD, Quanovate Tech Inc.

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

•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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

  • 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

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2J6W5
        • Deer Valley family Medicine Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 42 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single cohort
All 20 participants will use ClearBlue and Mira monitors on first morning urine
Device: Mira monitor comparison to ClearBlue monitor
Testing first morning urine with hormone test sticks at home

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 months
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 months
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
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Quanovate Tech Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 29, 2020

Primary Completion (Actual)

February 28, 2021

Study Completion (Actual)

April 22, 2021

Study Registration Dates

First Submitted

April 2, 2019

First Submitted That Met QC Criteria

April 6, 2019

First Posted (Actual)

April 9, 2019

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 21, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • HREBA.CTC-19-0046

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Fertility Disorders

Clinical Trials on Mira monitor comparison to ClearBlue monitor

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in United Arab Emirates

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe