Quantum Menstrual Health Monitoring Study (QMHMS)

October 24, 2024 updated by: Paul Yong, Quanovate Tech Inc.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T3H 0N9

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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).
Device: Mira Monitor tracking
Using the Mira monitor to track the menstrual cycle
Polycystic ovarian syndrome
To identify hormonal and other menstrual cycle biomarker variations in polycystic ovarian syndrome (PCOS) with oligomenorrhea.
Device: Mira Monitor tracking
Using the Mira monitor to track the menstrual cycle
Athletes
To identify hormonal and other menstrual cycle biomarker variations in oligomenorrheic athletes.
Device: Mira Monitor tracking
Using the Mira monitor to track the menstrual cycle

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 year
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
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
Time Frame: 1 year
FSH and E3G changes on the Mira monitor will predict the beginning of the fertile window
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Menstrual bleeding scores will be correlated with changes in progesterone
Time Frame: 1 year
Menstrual bleeding scores, including heavy bleeding, will be indicative of abnormal conditions like PCOS and correlated with progesterone abnormalities
1 year
Temperature rise will confirm ovulation in participants who have ovulated on ultrasound
Time Frame: 1 year
Temperature, like progesterone, will rise to confirm ovulation 3-5 days after the ultrasound-confirmed day of ovulation
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Quanovate Tech Inc.

Collaborators

Patricia Doyle-Baker

Investigators

  • Study Director: Thomas Bouchard, MD, University of Calgary

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2024

Primary Completion (Estimated)

May 1, 2025

Study Completion (Estimated)

May 1, 2026

Study Registration Dates

First Submitted

February 2, 2023

First Submitted That Met QC Criteria

June 29, 2023

First Posted (Actual)

July 10, 2023

Study Record Updates

Last Update Posted (Actual)

October 28, 2024

Last Update Submitted That Met QC Criteria

October 24, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REB23-0704

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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