Quantum Menstrual Health Monitoring Study

Trial Title: Quantum Menstrual Health Monitoring Study

NCT ID: NCT05936840

Condition: Menstrual Cycle Abnormal
Polycystic Ovary Syndrome
Athletes

Conditions: Official terms:
Polycystic Ovary Syndrome

Conditions: Keywords:
Quantitative urinary hormones
Follicle-stimulating hormone
Luteinizing hormone
Estrone-3-glucuronide
Pregnanediol glucuronide
Ultrasound

Study type: Observational

Overall status: Recruiting

Study design:

Time perspective: Prospective

Intervention:

Intervention type: Device
Intervention name: Mira Monitor tracking
Description: Using the Mira monitor to track the menstrual cycle
Arm group label: Athletes
Arm group label: Polycystic ovarian syndrome
Arm group label: Regular cycles

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.

Criteria for eligibility:

Study pop:
Previous ultrasound studies validating urine hormone monitor measurements have targeted 50 participants over 3 cycles, for a total of 150 menstrual cycles. With 150 cycles for analysis, the study would be adequately powered to detect differences of 0.5 days in cycle parameters (with an effect size of 0.2, alpha 0.05 and power of 80%). Oversampling up to 60 participants may be required to ensure that we have 150 cycles for analysis. We will attempt to recruit 50 participants with PCOS, and 50 athletes, using the same power calculation as above.

Sampling method: Non-Probability Sample
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

Gender: Female

Minimum age: 18 Years

Maximum age: 55 Years

Healthy volunteers: Accepts Healthy Volunteers

Locations:

Facility:
Name: Thomas Bouchard

Address:
City: Calgary
Zip: T3H 0N9
Country: Canada

Status: Recruiting

Contact:
Last name: Thomas Bouchard

Phone: 4036674296
Email: thomasbouchard@gmail.com

Start date: May 1, 2024

Completion date: May 1, 2026

Lead sponsor:
Agency: Quanovate Tech Inc.
Agency class: Industry

Collaborator:
Agency: Patricia Doyle-Baker
Agency class: Other

Source: Quanovate Tech Inc.

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05936840