Quantum Menstrual Health Monitoring Study

NCT05936840 | Recruiting FDA Device

• 1 other identifier: REB23-0704
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (2)

• Menstrual bleeding scores will be correlated with changes in progesterone

  1 year

• Temperature rise will confirm ovulation in participants who have ovulated on ultrasound

  1 year

Study Arms (3)

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).

Device: Mira Monitor tracking

Polycystic ovarian syndrome

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

Device: Mira Monitor tracking

Athletes

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

Device: Mira Monitor tracking

Interventions

Mira Monitor tracking DEVICE

Using the Mira monitor to track the menstrual cycle

Athletes; Polycystic ovarian syndrome; Regular cycles

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Quanovate Tech Inc.: lead
• Patricia Doyle-Baker: collaborator

Study Sites (1)

Thomas Bouchard

Calgary, Alberta, T3H 0N9, Canada

RECRUITING

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Study Officials

• Thomas Bouchard, MD

  University of Calgary

  STUDY DIRECTOR

Central Study Contacts

Thomas P Bouchard, MD

CONTACT

4036674296; thomasbouchard@quantumfertility.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 2, 2023
• First Posted: July 10, 2023
• Study Start: May 1, 2024
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2026
• Last Updated: October 28, 2024

Record last verified: 2024-10

Locations

CA (1)