Recruiting

Observational Study

Sponsor:

Quanovate Tech Inc.

Code:

NCT05936840

Conditions

Menstrual Cycle Abnormal

Polycystic Ovary Syndrome

Athletes

Eligibility Criteria

Sex: Female

Age: 18 - 55

Healthy Volunteers: Accepted

Interventions

Mira Monitor tracking

Study Details

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.

Conditions

Menstrual Cycle Abnormal

Polycystic Ovary Syndrome

Athletes

Study ID

NCT05936840

Start date

May 1, 2024

Status verified date

Oct, 2024

Completion date

May 1, 2026

Anticipated

Primary completion date

May 1, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 55

Healthy Volunteers: Accepted

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

Enrollment

150 participants

Anticipated

Interventions and Outcome Measures

Arms

Regular cycles

To characterize quantitative hormones in the urine using the Mira monitor, along with other menstrual cycle biomarkers, and validate these in reference to serum hormonal measurements and the gold-standard of the ultrasound-day of ovulation in participants with normal menstrual cycles (cycle length 24-38 days).

Polycystic ovarian syndrome

To identify hormonal and other menstrual cycle biomarker variations in polycystic ovarian syndrome (PCOS) with oligomenorrhea.

Athletes

To identify hormonal and other menstrual cycle biomarker variations in oligomenorrheic athletes.

Interventions

Mira Monitor tracking

Using the Mira monitor to track the menstrual cycle

Primary outcome measure

  • The rise and fall of urine luteinizing hormone will predict of ovulation in all participants with confirmed ovulation [ Time Frame: 1 year ]
  • The rise in urine progesterone will confirm ovulation in all participants who have ovulated based on ultrasound [ Time Frame: 1 year ]
  • 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 [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Thomas P Bouchard, MD

4036674296thomasbouchard@quantumfertility.com

Locations

Thomas Bouchard

Recruiting

Calgary, Alberta, Canada, T3H 0N9

Contacts

Thomas Bouchard

4036674296thomasbouchard@gmail.com

More Information

Sponsor

Quanovate Tech Inc.

Last update posted

Oct 28, 2024

Last verified

Oct, 2024

Keywords

  • Quantitative urinary hormones
  • Follicle-stimulating hormone
  • Luteinizing hormone
  • Estrone-3-glucuronide
  • Pregnanediol glucuronide
  • Ultrasound

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Quanovate Tech Inc. on 2024-10-28.