Quantum Menstrual Health Monitoring Study

NCT ID: NCT05936840

Last Updated: 2024-10-28

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-05-01
• Study Completion Date: 2026-05-01

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.

Conditions

Menstrual Cycle Abnormal; Polycystic Ovary Syndrome; Athletes

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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).

Mira Monitor tracking

Intervention Type: DEVICE

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.

Mira Monitor tracking

Intervention Type: DEVICE

Using the Mira monitor to track the menstrual cycle

Athletes

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

Mira Monitor tracking

Intervention Type: DEVICE

Using the Mira monitor to track the menstrual cycle

Interventions

Mira Monitor tracking

Using the Mira monitor to track the menstrual cycle

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Patricia Doyle-Baker

UNKNOWN

Sponsor Role: collaborator

Quanovate Tech Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Paul Yong

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Thomas Bouchard, MD

Role: STUDY_DIRECTOR

University of Calgary

Locations

Thomas Bouchard

Calgary, Alberta, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Thomas P Bouchard, MD

Role: CONTACT

thomasbouchard@quantumfertility.com

4036674296

Facility Contacts

Thomas Bouchard

Role: primary

thomasbouchard@gmail.com

4036674296

Other Identifiers

REB23-0704

Identifier Type: -

Identifier Source: org_study_id