Quantum Menstrual Health Monitoring Study
Quantitative Hormonal Biomarkers of Menstrual Health in Normal and Abnormal Cycles
Quanovate Tech Inc.
150 participants
May 1, 2024
OBSERVATIONAL
Conditions
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.
Eligibility
Inclusion Criteria5
- 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 Criteria11
- 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
Interventions
Using the Mira monitor to track the menstrual cycle
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05936840