FemTech Series

Ambulatory Hormone Monitoring of Ovulation: A Review of Research

By: Madeleine Shtrahman

Director’s Note: We conclude our FemTech Series with a research article published in 2022 in Medicina titled, “Complete Cycle Mapping Using a Quantitative At-Home Hormone Monitoring System in Prediction of Fertile Days, Confirmation of Ovulation, and Screening for Ovulation Issues Preventing Conception.” [1] The article offers an in-depth assessment of Proov Complete, a tool designed to not only confirm successful ovulation and fertile days, but even assess ovarian reserve. The article was summarized by Madeleine Shtrahman, a fourth-year medical student who participated in the virtual FACTS elective available to all students in the medical and health professions.

Introduction

Few products are available over-the-counter for patients to easily assess their ovarian reserve and future fertility. The article by Wegrzynowicz et al [1] summarized below describes the use of Proov Complete. This monitoring system available in one over-the-counter kit aims to accurately and sensitively predict ovarian reserve and fertile days, and confirm whether ovulation was successful.

 “[Proov Complete] aims to accurately and sensitively predict ovarian reserve and fertile days, and confirm whether ovulation was successful.”

A woman’s ability to detect her fertile days provides vital information when attempting to conceive. Yet, fewer than 13% of women can identify ovulation. [1]  As different women have different ovulatory cycles, it is important for them to know how to track their unique cycles with the available tools. Proov Complete tests follicle-stimulating hormone (FSH), estrone-3-glucuronide (E1G), luteinizing hormone (LH), and pregnanediol-3 glucuronide (PdG) to evaluate the entire fertile and implantation window.

From birth to age 37.5 years, the number of ovarian eggs drops from 1 million to less than 25,000. [1] As ovarian reserve decreases with age, conception becomes more challenging. Measuring basal levels of FSH as early as cycle day 3 (CD3) helps determine the remaining ovarian reserve. It also helps predict ovarian response, pregnancy outcomes with in-vitro fertilization (IVF), and stimulation quality. Most at-home fertility testing kits do not measure FSH, but Proov Complete does.

Methodology

 The study enrolled 40 women aged 24 to 46 years who were (1) trying to conceive, (2) not using hormonal contraceptives, and (3) had previously tracked at least one cycle using Proov Complete and the Insight App. Two hypotheses were tested. The first was that Proov Complete can confirm successful ovulation, defined as an ovulatory event producing sustained elevated PdG during the implantation window. The second hypothesis was that Proov Complete can predict up to six fertile days.

Upon learning through the app how to test the urine correctly, each participant tracked a single cycle in the app by using the first morning urine and dipping the Proov Multi-Hormone (MH) strip for 15 seconds. After ten minutes, the urine strips were scanned in the app. Cycle day 1 was defined as the first day of red menstrual blood flow. Use of MH strips was directed based on the average cycle length of the individual (4-6 days before predicted ovulation), and a baseline test to measure all four hormones was directed on cycle day 5. FSH testing was directed on cycle days 7 and 9.

To assess ovulation, the participants tested with MH strips 7-10 days post-peak fertility (first day of LH surge). After the testing performed 10 days post-peak, the app generated the Proov Insight Report. An ovulation score was given, measuring PdG production during the implantation window.

Results

Data analysis showed that Proov Complete MH strip results are reproducible (94% of all R-values > 0.8) and that the test is sensitive and specific for urinary LH, PdG, and E1G. All strips (100%) passed sensitivity testing. For E1G and PdG, 98% of strips passed specificity testing, and 93% passed for LH. Results also showed that Proov Complete predicts ovulation with LH surge, confirms ovulation with PdG rise, and provides information on ovarian reserve.

“Data analysis showed that Proov Complete MH strip results are reproducible (94% of all R-values > 0.8) and that the test is sensitive and specific for urinary LH, PdG, and E1G.”

Discussion

The Proov Complete system tests four key hormones in the urine to assess ovarian reserve, predict up to six fertile days, and confirm successful ovulation. The app then generates a comprehensive report with an ovulation score. Based on the patient’s needs, physicians can use this data to create a targeted treatment plan and monitor efficacy of treatments. Patients can also use their data to time intercourse correctly in the fertile period, increasing the likelihood of conception.

This system is non-invasive, affordable, easy to use, and available over-the-counter. Proov Complete is also the first at-home urinary hormone kit to collect FSH data, which is vital information in fertility management for people trying to conceive. Ovulatory dysfunction may occur in half of women trying to conceive, a result also seen in this study. Yet, when PdG levels reach 2.5 ug/mL or greater following an LH surge, ovulation can be confirmed (the first hypothesis). The second hypothesis was that Proov Complete can predict the entire fertile window, which is up to 6 days. The Proov MH tests detected up to 11 potentially fertile days, with an average of 5.32 days.

“Ovulatory dysfunction may occur in half of women trying to conceive, a result also seen in this study. Yet, when PdG levels reach 2.5 ug/mL or greater following an LH surge, ovulation can be confirmed.”

Overall, this kit provided users information about their hormone levels that is easy for patients and providers to interpret and discuss. Patients who are trying to conceive may track their hormones with this tool that can help guide them to achieve their goals. Still, more research is needed to further expand accessible options for tracking. It is important to continue to work towards affordable and equitable healthcare for all.

References

[1] Wegrzynowicz AK, Beckley A, Eyvazzadeh A, Levy G, Park J, Klein J. Complete Cycle Mapping Using a Quantitative At-Home Hormone Monitoring System in Prediction of Fertile Days, Confirmation of Ovulation, and Screening for Ovulation Issues Preventing Conception. Medicina (Kaunas). 2022;58(12):1853. Published 2022 Dec 15. doi:10.3390/medicina58121853

ABOUT THE AUTHOR

Madeleine Shtrahman

Madeleine Shtrahman is a fourth-year medical student at Ohio University Heritage College of Osteopathic Medicine in Cleveland, OH. She completed her undergraduate education at Ohio University in Athens, OH. She plans to do her residency in family medicine and is interested in addiction medicine and women’s health. She enrolled in the FACTS elective to provide comprehensive reproductive and family planning healthcare to her wide array of family medicine patients.

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