Quantum Natural Family Planning Pilot

Not Applicable

Completed

• Conditions: Fertility Disorders
• Interventions: Device: Mira monitor comparison to ClearBlue monitor

• Registration Number: NCT03908697
• Lead Sponsor: Quanovate Tech Inc.

Brief Summary

•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.

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 Timeline

• Study First Submitted: 2019-04-02
• Study First Submitted QC: 2019-04-06
• Study First Posted: 2019-04-09
• Study Start: 2020-05-29
• Primary Completion: 2021-02-28
• Study Completion: 2021-04-22
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-21
• Last Update Posted: 2025-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 26

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single cohort	Mira monitor comparison to ClearBlue monitor	All 20 participants will use ClearBlue and Mira monitors on first morning urine

Primary Outcome Measures

Name	Time	Method
Day of the estimated beginning of the fertile phase of the menstrual cycle:	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
Day of the estimated peak of the fertile phase of the menstrual cycle:	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
Day of the estimated end of the fertile phase of the menstrual cycle:	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 Outcome Measures

Name	Time	Method
Satisfaction and Ease of Use of a Electronic Fertility Monitor:	3 months	Measured by the modified 8 item Severy Satisfaction Scale; Total score rages from 8 - 24 with 24 being the highest satisfaction

Trial Locations

Locations (1)

Deer Valley family Medicine Clinic; 🇨🇦 Calgary, Alberta, Canada