Quantum Menstrual Health Monitoring Study

Quanovate Tech Inc.150 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

150

Conditions

Menstrual Cycle Abnormal Polycystic Ovary Syndrome Athletes

Interventions

Mira Monitor trackingDEVICE

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: 1 year

Secondary Outcomes

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

Time frame: 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

Time frame: 1 year

Quantum Menstrual Health Monitoring Study

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts