Quantum Menstrual Health Monitoring Study

Study Overview
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Brief Summary
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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.

Official Title
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Quantitative Hormonal Biomarkers of Menstrual Health in Normal and Abnormal Cycles

Conditions
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Menstrual Cycle Abnormal, Polycystic Ovary Syndrome, Athletes

Intervention / Treatment
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* Device: Mira Monitor tracking


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Regular cycles<br>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<br>* Using the Mira monitor to track the menstrual cycle<br>|
| Polycystic ovarian syndrome<br>To identify hormonal and other menstrual cycle biomarker variations in polycystic ovarian syndrome (PCOS) with oligomenorrhea. | Device: Mira Monitor tracking<br>* Using the Mira monitor to track the menstrual cycle<br>|
| Athletes<br>To identify hormonal and other menstrual cycle biomarker variations in oligomenorrheic athletes. | Device: Mira Monitor tracking<br>* Using the Mira monitor to track the menstrual cycle<br>|

What is the study measuring?
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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 | 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 | 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 | 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 | 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 | Temperature, like progesterone, will rise to confirm ovulation 3-5 days after the ultrasound-confirmed day of ovulation | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Quantitative urinary hormones, Follicle-stimulating hormone, Luteinizing hormone, Estrone-3-glucuronide, Pregnanediol glucuronide, Ultrasound