QNFP: Quantum Natural Family Planning Pilot

• Sponsor: Quanovate Tech Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03908697
• Collaborator: (none)
• Enrollment: 24
• Location: 1
• Arm: 1
• Actual Duration (Months): 10.8
• Patients Per Site Per Month: 2.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Fertility Disorders	Device: Mira monitor comparison to ClearBlue monitor	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 24 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Prospective cohort analysis of three menstrual cycles of hormone data, comparing two fertility monitors that analyze urine hormones. Satisfaction and ease of use will be assessed using surveys. Individual data will be anonymized.Prospective cohort analysis of three menstrual cycles of hormone data, comparing two fertility monitors that analyze urine hormones. Satisfaction and ease of use will be assessed using surveys. Individual data will be anonymized.
• Masking: None (Open Label)
• Masking Description: Anonymized demographic data
• Primary Purpose: Diagnostic
• Official Title: Comparison of Two Hormonal Fertility Monitors for Use in Natural Family Planning
• Actual Study Start Date: May 29, 2020
• Actual Primary Completion Date: Feb 28, 2021
• Actual Study Completion Date: Apr 22, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

2. 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

3. 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

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 42 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Deer Valley family Medicine Clinic	Calgary	Alberta	Canada	T2J6W5

Sponsors and Collaborators

• Quanovate Tech Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Official product website

Publications

• Bouchard TP, Fehring RJ, Schneider MM. Achieving Pregnancy Using Primary Care Interventions to Identify the Fertile Window. Front Med (Lausanne). 2018 Jan 9;4:250. doi: 10.3389/fmed.2017.00250. eCollection 2017.

• Responsible Party: Thomas Bouchard, MD, Clinical Lecturer, University of Calgary
• ClinicalTrials.gov Identifier: NCT03908697
• Other Study ID Numbers: HREBA.CTC-19-0046
• First Posted: Apr 9, 2019
• Last Update Posted: Jun 25, 2021
• Last Verified: Jun 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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

Study Results

No Results Posted as of Jun 25, 2021