Clinical trial NCT05936840: Quantum Menstrual Health Monitoring Study
Official title: Quantitative Hormonal Biomarkers of Menstrual Health in Normal and Abnormal Cycles
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Menstrual Cycle Abnormal
Polycystic Ovary Syndrome
Athletes
Keywords: Quantitative urinary hormones
Follicle-stimulating hormone
Luteinizing hormone
Estrone-3-glucuronide
Pregnanediol glucuronide
Ultrasound
Lead sponsor: Quanovate Tech Inc.
Sponsor class: INDUSTRY
Collaborators: name: Patricia Doyle-Baker
First posted: 2023-07-10
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study 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.

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

Primary outcomes:
measure: The rise and fall of urine luteinizing hormone will predict of ovulation in all participants with confirmed ovulation
timeFrame: 1 year
measure: The rise in urine progesterone will confirm ovulation in all participants who have ovulated based on ultrasound
timeFrame: 1 year
measure: 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
timeFrame: 1 year
Secondary outcomes:
measure: Menstrual bleeding scores will be correlated with changes in progesterone
timeFrame: 1 year
measure: Temperature rise will confirm ovulation in participants who have ovulated on ultrasound
timeFrame: 1 year
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Thomas Bouchard
state: Alberta
Study officials:
affiliation: University of Calgary
name: Thomas Bouchard, MD
role: STUDY_DIRECTOR
References: