Symptoms and General Pathology

All Conditions

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Syndrome

Polycystic Ovary Syndrome

Cysts

Ovarian Cysts

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Gonadal Disorders

Endocrine System Diseases

All Drugs and Chemicals

Reproductive Control Agents

Hormones

Follicle Stimulating Hormone

Estropipate

Estrone

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).

To identify hormonal and other menstrual cycle biomarker variations in polycystic ovarian syndrome (PCOS) with oligomenorrhea.

To identify hormonal and other menstrual cycle biomarker variations in oligomenorrheic athletes.

Using the Mira monitor to track the menstrual cycle

Mira Monitor tracking

Thomas P Bouchard, MD

Thomas Bouchard, MD

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.

Quantum Menstrual Health Monitoring Study

Quantitative Hormonal Biomarkers of Menstrual Health in Normal and Abnormal Cycles

The LH surge on the Mira monitor will accurately predict ovulation within 1-2 days referenced to the ultrasound-day of ovulation

The progesterone (PDG) rise on the Mira monitor will accurately confirm ovulation within 3-5 days of the ultrasound-day of ovulation

FSH and E3G changes on the Mira monitor will predict the beginning of the fertile window

Menstrual bleeding scores, including heavy bleeding, will be indicative of abnormal conditions like PCOS and correlated with progesterone abnormalities

Temperature, like progesterone, will rise to confirm ovulation 3-5 days after the ultrasound-confirmed day of ovulation

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Quantum Menstrual Health Monitoring Study	NCT05936840	Menstrual Cycle... Polycystic Ovar... Athletes	Mira Monitor tr...	18 Years - 55 Years	Quanovate Tech Inc.
Quantum Menstrual Health Monitoring Study	NCT05936840	Menstrual Cycle... Polycystic Ovar... Athletes	Mira Monitor tr...	18 Years - 55 Years	Quanovate Tech Inc.
Quantum Menstrual Health Monitoring Study	NCT05936840	Menstrual Cycle... Polycystic Ovar... Athletes	Mira Monitor tr...	18 Years - 55 Years	Quanovate Tech Inc.

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