QMHMS: Quantum Menstrual Health Monitoring Study

Sponsor

Quanovate Tech Inc. (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05936840

Collaborator

Patricia Doyle-Baker (Other)

150

Enrollment

31.6

Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Menstrual Cycle Abnormal Polycystic Ovary Syndrome Athletes	Device: Mira Monitor tracking

Study Design

Study Type:

Observational

Anticipated Enrollment :

150 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Quantitative Hormonal Biomarkers of Menstrual Health in Normal and Abnormal Cycles

Anticipated Study Start Date :

Sep 13, 2023

Anticipated Primary Completion Date :

May 1, 2025

Anticipated Study Completion Date :

May 1, 2026

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

The rise and fall of urine luteinizing hormone will predict of ovulation in all participants with confirmed ovulation [1 year]
The LH surge on the Mira monitor will accurately predict ovulation within 1-2 days referenced to the ultrasound-day of ovulation
The rise in urine progesterone will confirm ovulation in all participants who have ovulated based on ultrasound [1 year]
The progesterone (PDG) rise on the Mira monitor will accurately confirm ovulation within 3-5 days of the ultrasound-day of ovulation
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 [1 year]
FSH and E3G changes on the Mira monitor will predict the beginning of the fertile window

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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