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NCT Number: NCT05936840

Quantum Menstrual Health Monitoring Study

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.

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Key information

Conditions

Menstrual Cycle Abnormal Adnexal Diseases Athletes Cysts Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Neoplasms Ovarian Cysts Ovarian Diseases Polycystic Ovary Syndrome Urogenital Diseases

Age range

18 year–55 year

Sex eligibility

Female

Study type

Observational

Primary location

Thomas Bouchard

Calgary, Alberta, T3H 0N9, Canada

Location status: Recruiting

Location contact

Thomas Bouchard

CONTACT

[email protected]

4036674296

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mira Monitor tracking

Device

Using the Mira monitor to track the menstrual cycle

Primary outcomes

  1. The rise and fall of urine luteinizing hormone will predict of ovulation in all participants with confirmed ovulation

    Time frame: 1 year

    The LH surge on the Mira monitor will accurately predict ovulation within 1-2 days referenced to the ultrasound-day of ovulation

  2. The rise in urine progesterone will confirm ovulation in all participants who have ovulated based on ultrasound

    Time frame: 1 year

    The progesterone (PDG) rise on the Mira monitor will accurately confirm ovulation within 3-5 days of the ultrasound-day of ovulation

  3. 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

    FSH and E3G changes on the Mira monitor will predict the beginning of the fertile window

Secondary outcomes

  1. Menstrual bleeding scores will be correlated with changes in progesterone

    Time frame: 1 year

    Menstrual bleeding scores, including heavy bleeding, will be indicative of abnormal conditions like PCOS and correlated with progesterone abnormalities

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

    Time frame: 1 year

    Temperature, like progesterone, will rise to confirm ovulation 3-5 days after the ultrasound-confirmed day of ovulation

Study contacts

Contact information is provided by the study sponsor or research team.

Thomas P Bouchard, MD

CONTACT

[email protected]

4036674296

Sponsors and collaborators

Lead sponsor

Quanovate Tech Inc.

Industry

Collaborators

  • Patricia Doyle-Baker

Registry information

Official study title

Quantitative Hormonal Biomarkers of Menstrual Health in Normal and Abnormal Cycles

Acronym: QMHMS

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Jul 10, 2023
Registry last updated
Oct 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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