Quantum Menstrual Health Monitoring Study
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
| Condition(s) | Menstrual Cycle Abnormal, Polycystic Ovary Syndrome, Athletes |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| 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. |
| Who can participate | 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, b |
| Ages | 18 Years to 55 Years |
| Sex | Female |
| Accepts healthy volunteers | Yes |
| Lead sponsor | Quanovate Tech Inc. |
| Locations | Calgary, Alberta, Canada |
| Start date | 2024-05-01 |
| NCT ID | NCT05936840 |
| Official listing | https://clinicaltrials.gov/study/NCT05936840 |