Actively Recruiting

Age: 18Years - 55Years
FEMALE
Healthy Volunteers
ID05936840

Quantitative Hormonal Biomarkers of Menstrual Health in Normal and Abnormal Cycles

Led by Quanovate Tech Inc. · Updated on 2024-10-28

150

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

Sponsors

Q

Quanovate Tech Inc.

Lead Sponsor

P

Patricia Doyle-Baker

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating hormonal patterns in menstrual cycles to better understand ovulation and fertility markers in women with regular cycles, polycystic ovarian syndrome (PCOS), and athletes. The study focuses on measuring four key reproductive hormones in urine and comparing them to blood hormone levels and ultrasound-confirmed ovulation. Additional clinical signs like menstrual bleeding, temperature changes, vital signs, and sleep patterns are also tracked to provide a comprehensive picture of menstrual health. Participants will use the Mira Monitor device to track menstrual hormones and biomarkers throughout their cycles. The study includes groups with regular cycles, PCOS with irregular cycles, and oligomenorrheic athletes. Regular ultrasounds will be performed to confirm ovulation, and hormone levels such as luteinizing hormone, progesterone, follicle-stimulating hormone, and estrogen will be measured over one year to predict and confirm ovulation and fertile windows. Participants will visit the clinic regularly for ultrasounds and hormone testing during the study period. They will provide urine samples and record clinical signs such as menstrual bleeding and temperature changes. Researchers will analyze correlations between hormone changes and menstrual cycle characteristics. The study will last one year, during which menstrual health and ovulation markers will be closely monitored and validated with ultrasound and serum hormone data.

CONDITIONS

Brief Title

Quantum Menstrual Health Monitoring Study

Who Can Participate

Age: 18Years - 55Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Women aged 18 to 45 with regular menstruation, PCOS, or athlete status
  • Negative pregnancy test at the start and end of each cycle
  • Menstrual cycle lengths between 24 and 34 days
  • Knowledge of previous 3 menstrual cycle lengths
  • Ability to attend regular ultrasounds at the clinic during the study
Not Eligible

You will not qualify if you...

  • For women with regular cycles: anovulation in the last 3 cycles
  • Use of medications affecting ovulation (e.g., oral contraceptives, ovulation stimulants) currently or within past 3 months
  • Known ovulation or fertility impairing conditions: PCOS, endometriosis, pelvic inflammatory disease in last year, pituitary adenomas, exclusive breastfeeding
  • Previous surgeries affecting menstrual cycle: hysterectomy, bilateral oophorectomy
  • Currently pregnant
  • For PCOS and athlete groups: use of medications affecting ovulation currently or in past 3 months
  • Known fertility impairing conditions: pelvic inflammatory disease in last year, pituitary adenomas, exclusive breastfeeding
  • Previous surgeries impacting menstrual cycle: hysterectomy, bilateral oophorectomy
  • Currently pregnant

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - Up to 1 year

Participants use the Mira monitor device to track their menstrual cycle hormones and other biomarkers throughout their cycles.

Regular ultrasound visits at the clinic throughout the study

Trial Site Locations

Total: 1 location

1

Thomas Bouchard

Calgary, Alberta, Canada, T3H 0N9

Actively Recruiting

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Research Team

T

Thomas P Bouchard, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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