Quantum Natural Family Planning Pilot

NCT ID: NCT03908697

Last Updated: 2025-03-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-29

Study Completion Date

2021-04-22

Brief Summary

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•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

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* 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

Conditions

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Fertility Disorders

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Anonymized demographic data

Study Groups

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Single cohort

All 20 participants will use ClearBlue and Mira monitors on first morning urine

Group Type EXPERIMENTAL

Mira monitor comparison to ClearBlue monitor

Intervention Type DEVICE

Testing first morning urine with hormone test sticks at home

Interventions

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Mira monitor comparison to ClearBlue monitor

Testing first morning urine with hormone test sticks at home

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

42 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Quanovate Tech Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Thomas Bouchard, MD

Clinical Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Deer Valley family Medicine Clinic

Calgary, Alberta, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type BACKGROUND
PMID: 29376054 (View on PubMed)

Ecochard R, Bouchard T, Leiva R, Abdulla S, Dupuis O, Duterque O, Garmier Billard M, Boehringer H, Genolini C. Characterization of hormonal profiles during the luteal phase in regularly menstruating women. Fertil Steril. 2017 Jul;108(1):175-182.e1. doi: 10.1016/j.fertnstert.2017.05.012. Epub 2017 Jun 1.

Reference Type BACKGROUND
PMID: 28579410 (View on PubMed)

Leiva RA, Bouchard TP, Abdullah SH, Ecochard R. Urinary Luteinizing Hormone Tests: Which Concentration Threshold Best Predicts Ovulation? Front Public Health. 2017 Nov 28;5:320. doi: 10.3389/fpubh.2017.00320. eCollection 2017.

Reference Type BACKGROUND
PMID: 29234665 (View on PubMed)

Direito A, Bailly S, Mariani A, Ecochard R. Relationships between the luteinizing hormone surge and other characteristics of the menstrual cycle in normally ovulating women. Fertil Steril. 2013 Jan;99(1):279-285.e3. doi: 10.1016/j.fertnstert.2012.08.047. Epub 2012 Sep 19.

Reference Type BACKGROUND
PMID: 22999798 (View on PubMed)

Severy LJ, Robinson J, Findley-Klein C, McNulty J. Acceptability of a home monitor used to aid in conception: psychosocial factors and couple dynamics. Contraception. 2006 Jan;73(1):65-71. doi: 10.1016/j.contraception.2005.07.008. Epub 2005 Sep 19.

Reference Type BACKGROUND
PMID: 16371298 (View on PubMed)

Related Links

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https://www.miracare.com

Official product website

Other Identifiers

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HREBA.CTC-19-0046

Identifier Type: -

Identifier Source: org_study_id

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