Quantum Menstrual Health Monitoring Study

Recruiting

• Conditions: Menstrual Cycle Abnormal; Polycystic Ovary Syndrome; Athletes
• Interventions: Device: Mira Monitor tracking

• Registration Number: NCT05936840
• Lead Sponsor: Quanovate Tech Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-02-02
• Study First Submitted QC: 2023-06-29
• Study First Posted: 2023-07-10
• Study Start: 2024-05-01
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-24
• Last Update Posted: 2024-10-28
• Primary Completion: 2025-05-01
• Study Completion: 2026-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 150

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Regular cycles	Mira Monitor tracking	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).
Polycystic ovarian syndrome	Mira Monitor tracking	To identify hormonal and other menstrual cycle biomarker variations in polycystic ovarian syndrome (PCOS) with oligomenorrhea.
Athletes	Mira Monitor tracking	To identify hormonal and other menstrual cycle biomarker variations in oligomenorrheic athletes.

Primary Outcome Measures

Name	Time	Method
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
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
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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Thomas Bouchard; 🇨🇦 Calgary, Alberta, Canada