Quantum Menstrual Health Monitoring Study
Recruiting · NCT05936840 · Observational (researchers observe without assigning treatment) · Lead sponsor: Quanovate Tech Inc.
View the official record on ClinicalTrials.gov →Interventions studied
Mira Monitor tracking
What this trial is 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.
Who can take part
Age range
18 Years to 55 Years
Sex
Female
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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
Where it is running
1 location listed.
- Thomas Bouchard - Calgary, Alberta, Canada