Quantum Menstrual Health Monitoring Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-55
SponsorQuanovate Tech Inc.
About this trial
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
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Mira Monitor tracking
DeviceUsing the Mira monitor to track the menstrual cycle
Treatment groups
150 Participants
are divided into 3 treatment groupsGroup A: Regular cycles1 intervention
Group B: Polycystic ovarian syndrome1 intervention
Group C: Athletes1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
1 year2
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
Time frame
1 year3
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
Time frame
1 yearSecondary outcomes
1
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
Time frame
1 year2
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
Time frame
1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Quanovate Tech Inc.
Lead sponsor
University of British Columbia
Sponsor institution
Patricia Doyle-Baker
Collaborator
Source ClinicalTrials.gov