Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Patricia Doyle-Baker | UNKNOWN |
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Regular cycles | To characterize quantitative hormones in the urine using the Mira monitor, along with other menstrual cycle biomarkers, and validate these in reference to serum hormonal measurements and the gold-standard of the ultrasound-day of ovulation in participants with normal menstrual cycles (cycle length 24-38 days). |
| |
| Polycystic ovarian syndrome | To identify hormonal and other menstrual cycle biomarker variations in polycystic ovarian syndrome (PCOS) with oligomenorrhea. |
| |
| Athletes | To identify hormonal and other menstrual cycle biomarker variations in oligomenorrheic athletes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mira Monitor tracking | Device | Using the Mira monitor to track the menstrual cycle |
|
| Measure | Description | Time Frame |
|---|---|---|
| The rise and fall of urine luteinizing hormone will predict of ovulation in all participants with confirmed ovulation | The LH surge on the Mira monitor will accurately predict ovulation within 1-2 days referenced to the ultrasound-day of ovulation | 1 year |
| The rise in urine progesterone will confirm ovulation in all participants who have ovulated based on ultrasound | The progesterone (PDG) rise on the Mira monitor will accurately confirm ovulation within 3-5 days of the ultrasound-day of ovulation | 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 | FSH and E3G changes on the Mira monitor will predict the beginning of the fertile window | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Menstrual bleeding scores will be correlated with changes in progesterone | Menstrual bleeding scores, including heavy bleeding, will be indicative of abnormal conditions like PCOS and correlated with progesterone abnormalities | 1 year |
| Temperature rise will confirm ovulation in participants who have ovulated on ultrasound |
Not provided
Inclusion Criteria:
Exclusion Criteria:
For regular cycles
For PCOS and athlete groups:
Not provided
Not provided
Previous ultrasound studies validating urine hormone monitor measurements have targeted 50 participants over 3 cycles, for a total of 150 menstrual cycles. With 150 cycles for analysis, the study would be adequately powered to detect differences of 0.5 days in cycle parameters (with an effect size of 0.2, alpha 0.05 and power of 80%). Oversampling up to 60 participants may be required to ensure that we have 150 cycles for analysis. We will attempt to recruit 50 participants with PCOS, and 50 athletes, using the same power calculation as above.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Thomas P Bouchard, MD | Contact | 4036674296 | thomasbouchard@quantumfertility.com |
| Name | Affiliation | Role |
|---|---|---|
| Thomas Bouchard, MD | University of Calgary | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thomas Bouchard | Recruiting | Calgary | Alberta | T3H 0N9 | Canada |
Not provided
| ID | Term |
|---|---|
| D011085 | Polycystic Ovary Syndrome |
| ID | Term |
|---|---|
| D010048 | Ovarian Cysts |
| D003560 | Cysts |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 |
Not provided
Not provided
Not provided
Not provided
Not provided
Temperature, like progesterone, will rise to confirm ovulation 3-5 days after the ultrasound-confirmed day of ovulation |
| 1 year |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |