Menstrual Cycle AbnormalQMHMSNCT05936840
Quantum Menstrual Health Monitoring Study
An observational study of Menstrual Cycle Abnormal and Polycystic Ovary Syndrome, run by Quanovate Tech Inc. at 1 site in Canada.
Trial summary
The Quantum Menstrual Health Monitoring Study will measure four key reproductive hormones in the urine to characterize patterns that predict and confirm ovulation, referenced to serum hormones and the gold-standard of the ultrasound day of ovulation in participants with regular cycles. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menstrual Cycle Abnormal, Polycystic Ovary Syndrome, Athletes
- What is being tested?
- Mira Monitor tracking
- Type of treatment
- Medical device
- How many people
- 150 participants
- Where
- 1 siteCanada
- Study dates
- 1 May 2024to 1 May 2026
- Phase
- Observational
- 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 55 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Previous ultrasound studies validating urine hormone monitor measurements have targeted 50 participants over 3 cycles, for a total of 150 menstrual cycles. With 150 cycles for analysis, the study would be adequately powered to detect differences of 0.5 days in cycle parameters (with an effect size of 0.2, alpha 0.05 and power of 80%). Oversampling up to 60 participants may be required to ensure that we have 150 cycles for analysis. We will attempt to recruit 50 participants with PCOS, and 50 athletes, using the same power calculation as above.
Who may be able to join
- Regularly menstruating, PCOS or athlete participants aged 18-45
- Negative pregnancy test at the beginning and at the end of each cycle
- Cycle lengths 24-34 days
- Knowledge of previous 3 cycle lengths
- Able to travel to Calgary Clinic for regular ultrasounds during the study period
Who cannot join
- For regular cycles
- Anovulation in the last 3 cycles
- Currently or in the previous 3 months, on medications that are known to impair or stimulate ovulation (e.g. oral contraceptives, ovulation stimulants, etc)
- Known conditions that impair ovulation or fertility: polycystic ovarian syndrome, endometriosis, pelvic inflammatory disease in the last year, pituitary adenomas, exclusively breastfeeding
- Previous surgeries impacting the menstrual cycle: hysterectomy, bilateral oophorectomy
- Currently pregnant
Show all 11Show fewer
- For PCOS and athlete groups:
- Currently or in the previous 3 months, on medications that are known to impair or stimulate ovulation (e.g. oral contraceptives, ovulation stimulants, etc)
- Known conditions that impair ovulation or fertility: pelvic inflammatory disease in the last year, pituitary adenomas, exclusive breastfeeding
- Previous surgeries impacting the menstrual cycle: hysterectomy, bilateral oophorectomy
- Currently pregnant
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Thomas Bouchard
Calgary, Alberta, T3H 0N9
Thomas Bouchard, 4036674296, thomasbouchard@gmail.com
About this study
Official title: Quantitative Hormonal Biomarkers of Menstrual Health in Normal and Abnormal Cycles
The Quantum Menstrual Health Monitoring Study will measure four key reproductive hormones in the urine to characterize patterns that predict and confirm ovulation, referenced to serum hormones and the gold-standard of the ultrasound day of ovulation in participants with regular cycles. These normal cycles will provide a reference for comparison to irregular cycles in polycystic ovarian syndrome (PCOS) and athletes. Clinical signs in the menstrual cycle (e.g. menstrual bleeding, temperature) as well as vital sign and sleep patterns will also be referenced to hormonal changes.
- Being tested
- Mira Monitor tracking
- Keywords
- Quantitative urinary hormones, Follicle-stimulating hormone, Luteinizing hormone, Estrone-3-glucuronide, Pregnanediol glucuronide, Ultrasound
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mira Monitor trackingDevice
Using the Mira monitor to track the menstrual cycle
| Study group | Role | What they receive |
|---|---|---|
| Regular cycles | To characterize quantitative hormones in the urine using the Mira monitor, along with other menstrual cycle biomarkers, and validate these in reference to serum hormonal measurements and the gold-standard of the ultrasound-day of ovulation in participants with normal menstrual cycles (cycle length 24-38 days). Receives: Device: Mira Monitor tracking | |
| Polycystic ovarian syndrome | To identify hormonal and other menstrual cycle biomarker variations in polycystic ovarian syndrome (PCOS) with oligomenorrhea. Receives: Device: Mira Monitor tracking | |
| Athletes | To identify hormonal and other menstrual cycle biomarker variations in oligomenorrheic athletes. Receives: Device: Mira Monitor tracking |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rise and fall of urine luteinizing hormone will predict of ovulation in all participants with confirmed ovulation
The LH surge on the Mira monitor will accurately predict ovulation within 1-2 days referenced to the ultrasound-day of ovulation
Measured: 1 year
The rise in urine progesterone will confirm ovulation in all participants who have ovulated based on ultrasound
The progesterone (PDG) rise on the Mira monitor will accurately confirm ovulation within 3-5 days of the ultrasound-day of ovulation
Measured: 1 year
Follicle-stimulating hormone (FSH) and estrogen (E3G) changes will predict the onset of the fertile window at least 5 days before ovulation in participants with confirmed ovulation
FSH and E3G changes on the Mira monitor will predict the beginning of the fertile window
Measured: 1 year
Secondary outcomes (2)
Menstrual bleeding scores will be correlated with changes in progesterone
Menstrual bleeding scores, including heavy bleeding, will be indicative of abnormal conditions like PCOS and correlated with progesterone abnormalities
Measured: 1 year
Temperature rise will confirm ovulation in participants who have ovulated on ultrasound
Temperature, like progesterone, will rise to confirm ovulation 3-5 days after the ultrasound-confirmed day of ovulation
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2023
- Study start1 May 2024
- Primary completion1 May 2025 (estimated)
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Menstrual Cycle AbnormalStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Quanovate Tech Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Patricia Doyle-Baker
- Responsible party
- Principal investigator, Paul Yong, University of British Columbia
- Investigators
- Thomas Bouchard, MD, Study director, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05936840
- Sponsor's protocol ID
- REB23-0704
- Acronym
- QMHMS
- Status last verified
- Oct 2024
- First submitted
- 2 Feb 2023
- Last updated
- 28 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative Hormonal Biomarkers of Menstrual Health in Normal and Abnormal Cycles
- ClinicalTrials.gov ID
- NCT05936840
- Acronym / sponsor ID
- QMHMS / REB23-0704
- Keywords
- Quantitative urinary hormones, Follicle-stimulating hormone, Luteinizing hormone, Estrone-3-glucuronide, Pregnanediol glucuronide, Ultrasound
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Quanovate Tech Inc.Industry (pharma, biotech, devices)
- Collaborators
- Patricia Doyle-Baker
- Study start
- 1 May 2024 (actual)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 10 Jul 2023 (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 Quantum Menstrual Health Monitoring Study will measure four key reproductive hormones in the urine to characterize patterns that predict and confirm ovulation, referenced to serum hormones and the gold-standard of the ultrasound day of ovulation in participants with regular cycles. These normal cycles will provide a reference for comparison to irregular cycles in polycystic ovarian syndrome (PCOS) and athletes. Clinical signs in the menstrual cycle (e.g. menstrual bleeding, temperature) as well as vital sign and sleep patterns will also be referenced to hormonal changes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Regular cycles | – | Device: Mira Monitor trackingTo characterize quantitative hormones in the urine using the Mira monitor, along with other menstrual cycle biomarkers, and validate these in reference to serum hormonal measurements and the gold-standard of the ultrasound-day of ovulation in participants with normal menstrual cycles (cycle length 24-38 days). |
| Polycystic ovarian syndrome | – | Device: Mira Monitor trackingTo identify hormonal and other menstrual cycle biomarker variations in polycystic ovarian syndrome (PCOS) with oligomenorrhea. |
| Athletes | – | Device: Mira Monitor trackingTo identify hormonal and other menstrual cycle biomarker variations in oligomenorrheic athletes. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Previous ultrasound studies validating urine hormone monitor measurements have targeted 50 participants over 3 cycles, for a total of 150 menstrual cycles. With 150 cycles for analysis, the study would be adequately powered to detect differences of 0.5 days in cycle parameters (with an effect size of 0.2, alpha 0.05 and power of 80%). Oversampling up to 60 participants may be required to ensure that we have 150 cycles for analysis. We will attempt to recruit 50 participants with PCOS, and 50 athletes, using the same power calculation as above.
Key inclusion criteria (5 listed)
- Regularly menstruating, PCOS or athlete participants aged 18-45
- Negative pregnancy test at the beginning and at the end of each cycle
- Cycle lengths 24-34 days
- Knowledge of previous 3 cycle lengths
- Able to travel to Calgary Clinic for regular ultrasounds during the study period
Key exclusion criteria (11 listed)
- For regular cycles
- For PCOS and athlete groups:
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 trackingUsing the Mira monitor to track the menstrual cycle | Device | Athletes, Polycystic ovarian syndrome, Regular cycles |
Primary outcome
The rise and fall of urine luteinizing hormone will predict of ovulation in all participants with confirmed ovulation
Time frame: 1 year
The LH surge on the Mira monitor will accurately predict ovulation within 1-2 days referenced to the ultrasound-day of ovulation
The rise in urine progesterone will confirm ovulation in all participants who have ovulated based on ultrasound
Time frame: 1 year
The progesterone (PDG) rise on the Mira monitor will accurately confirm ovulation within 3-5 days of the ultrasound-day of ovulation
Follicle-stimulating hormone (FSH) and estrogen (E3G) changes will predict the onset of the fertile window at least 5 days before ovulation in participants with confirmed ovulation
Time frame: 1 year
FSH and E3G changes on the Mira monitor will predict the beginning of the fertile window
2 secondary outcomes
Menstrual bleeding scores will be correlated with changes in progesterone
Time frame: 1 year
Temperature rise will confirm ovulation in participants who have ovulated on ultrasound
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2024.
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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.
Thomas Bouchard, MD study director
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Menstrual Cycle Abnormal and Polycystic Ovary Syndrome, 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 5 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 28 Oct 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thomas P Bouchard, MD (4036674296, thomasbouchard@quantumfertility.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rise and fall of urine luteinizing hormone will predict of ovulation in all participants with confirmed ovulation (time frame: 1 year). 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?
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 28 Oct 2024.