Research Methods · Study Design

Establishing a Gold Standard for Quantitative Menstrual Cycle Monitoring

Bouchard T, Yong P, Doyle-Baker P

Published August 23, 2023 Medicina (Kaunas, Lithuania)
DOI 10.3390/medicina59091513 PMID 37763632 PMC PMC10533176
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RRM Academy Synopsis

Calgary study will test home urine hormone tracking against ultrasound

A Calgary team will test whether the Mira home urine monitor finds the day of ovulation seen on ultrasound. The paper is a plan and reports no results. Three groups will track three cycles each: women with regular cycles, women with PCOS (polyendocrine metabolic ovarian syndrome, PMOS) and irregular cycles, and athletes with irregular cycles.

Key Findings

  • The authors plan a sample of 50 participants over 3 cycles, which gives 150 menstrual cycles, and use the same sample size for the PCOS and athlete groups.
  • Recruitment may rise to 60 participants to reach 150 cycles for analysis.
  • Scans at one Calgary clinic will follow the follicle, with approximately 6–8 ultrasounds each cycle and 18–24 across the study.
  • Participants test first-morning urine daily with the Mira monitor for FSH, E13G, LH, and PDG. Blood draws cover the follicular phase, ovulation, and the luteal phase.
  • The main analysis correlates the ultrasound day of ovulation with the LH peak on the monitor and with the day progesterone rises.

Interpretation

The paper describes a planned cohort study, meaning a group followed forward in time. With no participant data, the idea that the monitor predicts and confirms ovulation stays untested. The authors state that no formal study has compared the Mira monitor with ultrasound. Recruitment runs through primary care clinics, university social media and word of mouth. All scans happen at one clinic. The authors call the hormone-pattern modelling hypothesis-generating.

RRM Context

Charting-based care needs to know which signs confirm ovulation. A temperature shift, mucus and a hormone rise each point to an ovulatory event. The authors choose repeated ultrasound of the follicle as the reference. Restorative reproductive medicine treats the ovulatory cycle as a vital sign. This design checks urine hormone patterns against that reference in women with irregular cycles.

Abstract

Background and Objectives

The Quantum Menstrual Health Monitoring Study will measure four key reproductive hormones in the urine (follicle-stimulating hormone, FSH; estrone-3-glucuronide, E13G; luteinizing hormone, LH; and pregnanediol glucuronide, PDG) 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 subjects with polycystic ovarian syndrome (PCOS) and athletes.

Materials and Methods

Participants will track their menstrual cycles for 3 months and be provided with an at-home urine hormone monitor (Mira monitor) to predict ovulation. The day of ovulation will be confirmed with serial ultrasounds completed in a community clinic. Urine results will be compared to serum hormone values. Other markers of menstrual health, such as bleeding patterns and temperature changes, will be determined using a customized app. Three groups will be recruited. Group 1 will include those with consistent regular cycle lengths (between 24-38 days), and will be compared to two groups with irregular cycle lengths (with increased cycle length variability and longer cycles). Group 2 will include those with polycystic ovarian syndrome (PCOS) with irregular cycles and Group 3 will include individuals participating in high levels of exercise with irregular cycles.

Hypothesis

The Mira monitor quantitative urine hormone pattern will accurately correlate with serum hormonal levels and will predict (with LH) and confirm (with PDG) the ultrasound day of ovulation in those with regular cycles as well as those with irregular cycles.

Rationale

Once the ultrasound validation is complete, tools like the Mira monitor with a customized app may become a new standard for at-home and remote clinical monitoring of the menstrual cycle without having to use labor-intensive follicular-tracking ultrasound or follow serum hormone changes.

Conclusions

Precision monitoring of the menstrual cycle is expected to impact individuals who want to increase their menstrual health literacy and guide decisions about fertility.

Topics

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Related research

Research Methods › Study Design › Cohort Studies · Menstrual Cycle › Cycle Biomarkers › Hormonal Markers · Reproductive Endocrinology › Ovulation Physiology › Ovulation Disorder Classification
Thomas Bouchard
Tom Bouchard, T Bouchard
PMID 37763632 37763632 DOI 10.3390/medicina59091513 10.3390/medicina59091513 Bouchard et al. 2023, Bouchard 2023