Fertility DisordersQNFPNCT03908697
Quantum Natural Family Planning Pilot
A study testing Mira monitor comparison to ClearBlue monitor in people with Fertility Disorders, run by Quanovate Tech Inc. at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 42 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fertility Disorders
- What is being tested?
- Mira monitor comparison to ClearBlue monitor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteCanada
- Study dates
- 29 May 2020to 22 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 42 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- • Menstrual cycle ranging between 21-42 days
- At least 3 cycles after cessation of breastfeeding
Who cannot join
- • 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Conditions
- Fertility Disorders
- Being tested
- Mira monitor comparison to ClearBlue monitor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mira monitor comparison to ClearBlue monitorDevice
Testing first morning urine with hormone test sticks at home
| Study group | Role | What they receive |
|---|---|---|
| Single cohort | Experimental | All 20 participants will use ClearBlue and Mira monitors on first morning urine Receives: Device: Mira monitor comparison to ClearBlue monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Day of the estimated beginning of the fertile phase of the menstrual cycle:
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
Measured: 3 months
Day of the estimated peak of the fertile phase of the menstrual cycle:
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
Measured: 3 months
Day of the estimated end of the fertile phase of the menstrual cycle:
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
Measured: 3 months
Secondary outcomes (1)
Satisfaction and Ease of Use of a Electronic Fertility Monitor:
Measured by the modified 8 item Severy Satisfaction Scale
Total score rages from 8 - 24 with 24 being the highest satisfaction
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2019
- Study start29 May 2020
- Primary completion28 Feb 2021
- Study completion22 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Fertility DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Quanovate Tech Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Thomas Bouchard, MD, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03908697
- Sponsor's protocol ID
- HREBA.CTC-19-0046
- Acronym
- QNFP
- Status last verified
- Mar 2025
- First submitted
- 2 Apr 2019
- Last updated
- 24 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 29376054Ecochard 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.
PubMed 28579410Leiva 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.
PubMed 29234665Direito 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.
PubMed 22999798Severy 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.
PubMed 16371298
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Hormonal Fertility Monitors for Use in Natural Family Planning
- ClinicalTrials.gov ID
- NCT03908697
- Acronym / sponsor ID
- QNFP / HREBA.CTC-19-0046
- Conditions
- Fertility Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Quanovate Tech Inc.Industry (pharma, biotech, devices)
- Study start
- 29 May 2020 (actual)
- Primary completion
- 28 Feb 2021 (actual)
- Study completion
- 22 Apr 2021 (actual)
- First posted
- 9 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
•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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Single cohort | Experimental | Device: Mira monitor comparison to ClearBlue monitorAll 20 participants will use ClearBlue and Mira monitors on first morning urine |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- • Menstrual cycle ranging between 21-42 days
Key exclusion criteria (4 listed)
- • Not currently on medications that affect ovulation and 3 months prior
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mira monitor comparison to ClearBlue monitorTesting first morning urine with hormone test sticks at home | Device | Single cohort |
Primary outcome
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
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
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
1 secondary outcome
Satisfaction and Ease of Use of a Electronic Fertility Monitor:
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2025.
- Background: PubMed 29376054Bouchard 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.
- Results publication: PubMed 28579410Ecochard 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.
- Results publication: PubMed 29234665Leiva 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.
- Results publication: PubMed 22999798Direito 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.
- Results publication: PubMed 16371298Severy 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.
- Official product websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mira monitor comparison to ClearBlue monitor in people with Fertility Disorders, run by Quanovate Tech Inc. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Day of the estimated beginning of the fertile phase of the menstrual cycle: (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03908697, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2025.