Quantum Menstrual Health Monitoring Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Mira Monitor tracking.
- Who it may be relevant to
- Registry conditions: Menstrual Cycle Abnormal, Polycystic Ovary Syndrome, Athletes. Basic parameters: 18 years — 55 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Quantitative Hormonal Biomarkers of Menstrual Health in Normal and Abnormal Cycles
Overview
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.
Interventions
- Device Mira Monitor tracking
Using the Mira monitor to track the menstrual cycle
Primary outcome measures
- The rise and fall of urine luteinizing hormone will predict of ovulation in all participants with confirmed ovulation [Time frame: 1 year]
- The rise in urine progesterone will confirm ovulation in all participants who have ovulated based on ultrasound [Time frame: 1 year]
- Follicle-stimulating hormone (FSH) and estrogen (E3G) changes will predict the onset of the fertile window at least 5 days before ovulation in participants with confirmed ovulation [Time frame: 1 year]
Secondary outcome measures (2)
- Menstrual bleeding scores will be correlated with changes in progesterone [Time frame: 1 year]
- Temperature rise will confirm ovulation in participants who have ovulated on ultrasound [Time frame: 1 year]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Canada · 1 center
- Thomas Bouchard — Calgary
Identifiers
NCT: NCT05936840 · REB23-0704