Athletes, Menstrual Cycle Abnormal, Polycystic Ovary Syndrome
Conditions
Keywords
Quantitative urinary hormones, Follicle-stimulating hormone, Luteinizing hormone, Estrone-3-glucuronide, Pregnanediol glucuronide, Ultrasound
Brief 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.
Interventions
DEVICEMira Monitor tracking
Using the Mira monitor to track the menstrual cycle
Sponsors
Patricia Doyle-Baker
Quanovate Tech Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The rise and fall of urine luteinizing hormone will predict of ovulation in all participants with confirmed ovulation | 1 year | The LH surge on the Mira monitor will accurately predict ovulation within 1-2 days referenced to the ultrasound-day of ovulation |
| The rise in urine progesterone will confirm ovulation in all participants who have ovulated based on ultrasound | 1 year | The progesterone (PDG) rise on the Mira monitor will accurately confirm ovulation within 3-5 days of the ultrasound-day of ovulation |
| 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 | 1 year | FSH and E3G changes on the Mira monitor will predict the beginning of the fertile window |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Menstrual bleeding scores will be correlated with changes in progesterone | 1 year | Menstrual bleeding scores, including heavy bleeding, will be indicative of abnormal conditions like PCOS and correlated with progesterone abnormalities |
| Temperature rise will confirm ovulation in participants who have ovulated on ultrasound | 1 year | Temperature, like progesterone, will rise to confirm ovulation 3-5 days after the ultrasound-confirmed day of ovulation |
Countries
Canada
Contacts
Primary ContactThomas P Bouchard, MD
Outcome results
None listed