Quantum Menstrual Health Monitoring Study (QMHMS)

Quanovate Tech

Status: Enrolling

Conditions: Athletes; Polycystic Ovary Syndrome; Menstrual Cycle Abnormal

Treatments: Device: Mira Monitor tracking

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT05936840

REB23-0704

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: Female

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

150 participants in 3 patient groups

Regular cycles

Description:

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).

Treatment:

Device: Mira Monitor tracking

Polycystic ovarian syndrome

Description:

To identify hormonal and other menstrual cycle biomarker variations in polycystic ovarian syndrome (PCOS) with oligomenorrhea.

Treatment:

Device: Mira Monitor tracking

Athletes

Description:

To identify hormonal and other menstrual cycle biomarker variations in oligomenorrheic athletes.

Treatment:

Device: Mira Monitor tracking