NCT05936840

Quantum Menstrual Health Monitoring Study

Quantitative Hormonal Biomarkers of Menstrual Health in Normal and Abnormal Cycles

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 150 (estimated)
• Sponsor: Quanovate Tech Inc. · Industry
• Sex: Female
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Menstrual Cycle Abnormal
• Polycystic Ovary Syndrome
• Athletes

Interventions

Type	Name	Description
DEVICE	Mira Monitor tracking	Using the Mira monitor to track the menstrual cycle

Timeline

• Start date: 2024-05-01
• Primary completion: 2025-05-01
• Completion: 2026-05-01
• First posted: 2023-07-10
• Last updated: 2024-10-28

Locations

1 site across 1 country: Canada

Regulatory

• FDA-regulated device study