Monitoring menstrual health through hormone measurement
Quantitative Hormonal Biomarkers of Menstrual Health in Normal and Abnormal Cycles
This study is testing if tracking hormone levels in urine can help understand ovulation patterns in women with regular and irregular menstrual cycles, including those with PCOS and athletes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | Female |
| Sponsor | Quanovate Tech Inc. Industry-sponsored |
| Locations | 1 site (Calgary, Alberta) |
| Trial ID | NCT05936840 on ClinicalTrials.gov |
What this trial studies
The Quantum Menstrual Health Monitoring Study aims to measure four key reproductive hormones in urine to identify patterns that predict and confirm ovulation. This observational study will compare hormonal data from participants with regular menstrual cycles to those with irregular cycles, such as individuals with polycystic ovary syndrome (PCOS) and athletes. Participants will track their menstrual cycles, vital signs, and sleep patterns, which will be correlated with hormonal changes and ultrasound-confirmed ovulation. The study will utilize the Mira Monitor for hormone tracking.
Who should consider this trial
Good fit: Ideal candidates include regularly menstruating women aged 18-45, those with PCOS, or athletes who meet specific inclusion criteria.
Not a fit: Patients with known conditions that impair ovulation or fertility, such as endometriosis or those currently pregnant, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into menstrual health and improve ovulation prediction for women with irregular cycles.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in understanding hormonal patterns related to menstrual health.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Calgary, Alberta
- Thomas Bouchard — Calgary, Alberta, Canada (Recruiting)
Study contacts
- Study coordinator: Thomas P Bouchard, MD
- Email: thomasbouchard@quantumfertility.com
- Phone: 4036674296
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.