RecruitingNCT05936840

Quantum Menstrual Health Monitoring Study

Quantitative Hormonal Biomarkers of Menstrual Health in Normal and Abnormal Cycles


Sponsor

Quanovate Tech Inc.

Enrollment

150 participants

Start Date

May 1, 2024

Study Type

OBSERVATIONAL

Conditions

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. 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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 55 Years

Plain Language Summary

Simplified for easier understanding

This study is monitoring menstrual cycles and ovulation in detail using ultrasound and wearable sensors, including a "quantum" monitoring device, in regularly cycling women, women with PCOS (polycystic ovary syndrome), and female athletes. The goal is to understand how cycle tracking technologies perform across different groups. **You may be eligible if...** - You are aged 18–45 and regularly menstruating, have PCOS, or are a female athlete - Your cycle lengths are 24–34 days and you know your last 3 cycle lengths - You test negative for pregnancy at the start and end of each study cycle - You are able to travel to a clinic in Calgary for regular ultrasound appointments **You may NOT be eligible if...** - You have not been ovulating in your last 3 cycles - You are currently on medications that affect ovulation (such as oral contraceptives or ovulation stimulants) - You have conditions affecting fertility (such as endometriosis, pelvic inflammatory disease in the past year, or pituitary problems) - You are trying to get pregnant during the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEMira Monitor tracking

Using the Mira monitor to track the menstrual cycle


Locations(1)

Thomas Bouchard

Calgary, Alberta, Canada

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NCT05936840


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