Quantum Menstrual Health Monitoring Study

Polycystic Ovary Syndrome Clinical Trial

— QMHMS  

Official title:

Quantitative Hormonal Biomarkers of Menstrual Health in Normal and Abnormal Cycles

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05936840
• Other study ID #: REB23-0704
• Status: Not yet recruiting
• Start date: September 13, 2023
• Est. completion date: May 1, 2026

Study information

• Verified date: June 2023
• Source: Quanovate Tech Inc.
• Contact: Thomas P Bouchard, MD
• Phone: 4036674296
• Email: thomasbouchard[@]quantumfertility.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: May 1, 2026
• Est. primary completion date: May 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Athletes
• Menstrual Cycle Abnormal
• Polycystic Ovary Syndrome

Intervention

Device:
• Mira Monitor tracking
Using the Mira monitor to track the menstrual cycle

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Quanovate Tech Inc.	Patricia Doyle-Baker

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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