NCT05936840 Quantum Menstrual Health Monitoring Study
| NCT ID | NCT05936840 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Quanovate Tech Inc. |
| Condition | Menstrual Cycle Abnormal |
| Study Type | OBSERVATIONAL |
| Enrollment | 150 participants |
| Start Date | 2024-05-01 |
| Primary Completion | 2025-05-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 150 participants in total. It began in 2024-05-01 with a primary completion date of 2025-05-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Thomas Bouchard, MD
STUDY DIRECTOR
University of Calgary
Frequently Asked Questions
Who can join the NCT05936840 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 55 Years, studying Menstrual Cycle Abnormal. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05936840 currently recruiting?
Yes, NCT05936840 is actively recruiting participants. Contact the research team at thomasbouchard@quantumfertility.com for enrollment information.
Where is the NCT05936840 trial being conducted?
This trial is being conducted at Calgary, Canada.
Who is sponsoring the NCT05936840 clinical trial?
NCT05936840 is sponsored by Quanovate Tech Inc.. The principal investigator is Thomas Bouchard, MD at University of Calgary. The trial plans to enroll 150 participants.