Comparing Urinary Hormone Monitors, Tools That Help Women Achieve and Avoid Pregnancy
By: Blakeley Schiffman
Editor’s Note: For decades, researchers have sought ways to help women and couples more easily identify their window of fertility. They have examined cervical mucus observations, basal body temperature, and urinary hormone measurements to better track women’s ovulation. This has led to the development of different fertility awareness-based methods that women can choose to use for family planning or health monitoring. FACTS just published a study on the impact of a shared decision making tool we developed to help women choose the method best for them. One of the methods included in the tool is the Marquette Method, which utilizes hormone monitoring – now made even more accessible with new innovations in urinary hormone monitors. Blakeley Schiffman, a first-year resident and former FACTS elective participant, summarized a 2021 article that compared a new fertility monitor with a more established one. Published in the National Library of Medicine, the article is titled “Quantitative versus qualitative estrogen and luteinizing hormone testing for personal fertility monitoring.”
Introduction
In the 1970s and 1980s, the World Health Organization sponsored a series of studies evaluating the use of urinary hormones to identify the fertile window and ovulation. The studies investigated temporal relationships between urinary hormones, cervical mucus observations, and ultrasound-confirmed ovulation. The hormone estrone-3-glucuronide (E3G) was found to be the best predictor of the beginning of the fertile window, while luteinizing hormone (LH) best predicted the onset of ovulation [1]. Following these studies, the first urinary hormone monitor (the Ovarian Monitor) was developed in the 1980s by Dr. James Brown and colleagues to detect estrogen and progesterone. Unfortunately, due to the time required to conduct the hormonal assay at home, the monitor was not a practical choice for the everyday user. By the late 1990s, the ClearBlue Fertility Monitor was developed, which instead evaluated urine levels of E3G and LH by giving daily readings of ‘low,’ ‘high,’ or ‘peak.’ This monitor paved the way for health professionals at Marquette University to then develop the Marquette Method algorithm, which allows women to confidently identify the beginning and end of the fertile window.
The Marquette Method protocols offer the option of using the ClearBlue Fertility Monitor alone or in combination with observations of cervical mucus. When used to avoid pregnancy over a 12-month period, the Marquette Method boasts an unintended pregnancy rate of 0 to 2.1 per 100 women with correct use and just 2.0 to 14.7 unintended pregnancies with typical use. [2], [3]
Urinary hormone assessment has now expanded beyond the ClearBlue Fertility Monitor to include new monitors, such as the Mira monitor. The Mira monitor similarly assesses E3G and LH. While the ClearBlue Fertility Monitor provides ‘low,’ ‘high,’ or ‘peak’ readings, the Mira monitor instead provides daily quantitative values for those hormones. Theoretically, quantitative data could minimize the days of required abstinence for those wishing to avoid pregnancy, as well as help couples hoping to conceive to more efficiently focus the timing of intercourse. The purpose of the 2021 study by Bouchard, Fehring, and Mu was thus to validate the findings of the new Mira monitor, compared to the well-established ClearBlue Fertility Monitor [1].
Methodology
The study sample included 20 healthy women who were currently monitoring their urine for E3G and LH using the ClearBlue Fertility Monitor. Study participants also had to be between 18 and 42 years old, have three previous menstrual cycles between 21 and 42 days long, not be pregnant, and be at least three cycles past breastfeeding. Participants were excluded if they had been on medications affecting ovulation within three months of the study, pregnant, actively breastfeeding, or had known infertility issues, including diagnoses of polycystic ovary syndrome or endometriosisParticipants tested their first morning urine with both the Mira monitor and ClearBlue Fertility Monitor test strips in the same urine sample. For a total of three menstrual cycles, women were instructed to test daily — starting on the sixth day of the menstrual cycle through the fourth day after the first LH peak, as indicated on the ClearBlue Fertility Monitor. Following the completion of three cycles, the participants were then asked to complete a satisfaction survey evaluating the ease of use of the monitors and the perceived assistance with their fertility goals.
The ClearBlue Fertility Monitor defined the estimated day of ovulation (EDO) as the second ‘peak’ day, while the Mira monitor defined EDO as the day after the LH peak. The LH peak was identified as the highest-recorded LH reading, followed by a 50% decrease over the next two days.
Results
Researchers found the EDO of the two monitors was highly correlated (r = 0.984). The Mira monitor LH peak day coincided with one of the ClearBlue Fertility Monitor ‘peak’ days 86% of the time.
“The Mira monitor LH peak day coincided with one of the ClearBlue Fertility Monitor ‘peak’ days 86% of the time.”
However, total satisfaction scores were higher for the ClearBlue Fertility Monitor than the Mira monitor. Specifically, the ClearBlue Fertility Monitor had higher satisfaction scores when it came to ‘overall opinion for avoiding pregnancy,’ how well the monitor ‘helped to avoid pregnancy,’ and the ‘chances of avoiding pregnancy next month.’ However, none of the differences in these parameters ended up being statistically significant after applying the Bonferroni correction.
When asked for monitor preference, 52.6% of participants preferred the CBFM, 36.8% preferred Mira, and 10.5% had no preference.
Discussion
This study raises the question of whether or not women desire quantitative urinary hormone data. For women who are “science-minded” and “data-driven,” seeing numerical data on a monitor, as opposed to words, may inspire more confidence. Women and couples trying to conceive may desire as much specific data as possible, especially if struggling with infertility. Adolescents or women interested in using the Marquette Method to monitor health may prefer the more simplistic qualitative data, as opposed to detailed quantitative data. Preferences will vary greatly among patient populations, and it is important that we, as physicians, clinicians, and educators, recall this. Our role is to present all options and share the decision-making process with our patients as they decide which method and monitor aligns best with their preferences and goals.
“Our role is to present all options and share the decision-making process with our patients as they decide which method aligns best with their preferences and goals.”
Participants’ preference for the ClearBlue Fertility Monitor over the Mira monitor is unsurprising, mainly due to the fact that all participants had prior experience using the former. In addition, Mira results may be more difficult to interpret because of the daily fluctuations in E3G values. To more accurately assess satisfaction without the risk of bias, further studies are needed that include participants without previous experience using either monitor.
Future research should address the generalizability of this study to the general female population. Pregnant and breastfeeding women, as well as those with irregular cycles, anovulation, known infertility, PCOS, or endometriosis, were excluded from the study. However, it is important to note that menstrual irregularities occur in an estimated 14% to 25% of females of childbearing age and endometriosis affects at least 10% of these women. While this ‘baseline’ study is necessary for validation of the Mira monitor’s results compared with that of the well-established ClearBlue Fertility Monitor, additional studies including women with the aforementioned exclusion criteria are needed.
Author commentary: Dr. Thomas Bouchard* – New quantitative urinary monitoring with the Mira monitor, or other monitors that measure hormone levels, may have significant advantages in detecting lower-range LH surges not picked up by the ClearBlue Fertility Monitor, as well as identifying whether the elusive beginning of the fertile window can be accurately determined by quantitative E3G levels. We proposed a possible method of identifying follicular activity, where a woman could ask whether her E3G levels were > 150 ng/mL today or yesterday, and if the answer is yes, then she should consider herself fertile. This could have a wide variety of applications for the postpartum and perimenopausal periods, for women experiencing long and irregular cycles, and for women taking certain medications. As suggested in this review, more studies are needed to evaluate this algorithm for the fertile window in special circumstances.
* Dr. Thomas Bouchard is one of our featured speakers in our 2022 Virtual Conference. It is not too late to register here and pay for recordings to receive access to his presentations about his latest research in FemTech.
[1] Bouchard TP, Fehring RJ, Mu Q. Quantitative versus qualitative estrogen and luteinizing hormone testing for personal fertility monitoring. Expert Rev Mol Diagn. 2021;21(12):1349-1360. doi:10.1080/14737159.2021.2000393
[2] Fehring RJ, Schneider M, Raviele K, Rodriguez D, Pruszynski J. Randomized comparison of two Internet-supported fertility-awareness-based methods of family planning. Contraception. (2013) 88:24–30. doi: 10.1016/j.contraception.2012.10.010
[3] Fehring RJ, Schneider M. Effectiveness of a natural family planning service program. MCN Am J Matern Child Nurs. (2017) 42:43–9. doi: 10.1097/NMC.0000000000000296
ABOUT THE AUTHOR
Blakeley Schiffman, MD
Blakeley Schiffman, MD is a 2022 graduate of University at Buffalo’s Jacobs School of Medicine and Biomedical Sciences. She is now a first year resident in Obstetrics-Gynecology at Hofstra/Northwell North Shore-LIJ in Queens, NY. Blakeley took both parts of the FACTS Elective in her fourth year of medical school and looks forward to incorporating Fertility awareness based methods into practice for health maintenance, addressing gynecologic pathology, family planning and infertility.
