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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05936840
Other study ID # REB23-0704
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date September 13, 2023
Est. completion date May 1, 2026

Study information

Verified date June 2023
Source Quanovate Tech Inc.
Contact Thomas P Bouchard, MD
Phone 4036674296
Email thomasbouchard@quantumfertility.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 150
Est. completion date May 1, 2026
Est. primary completion date May 1, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 55 Years
Eligibility 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

Study Design


Intervention

Device:
Mira Monitor tracking
Using the Mira monitor to track the menstrual cycle

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Quanovate Tech Inc. Patricia Doyle-Baker

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Secondary 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
Secondary Temperature rise will confirm ovulation in participants who have ovulated on ultrasound Temperature, like progesterone, will rise to confirm ovulation 3-5 days after the ultrasound-confirmed day of ovulation 1 year
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