Description

What this project is and how it came to be

Vision

The technical vision of our project is the development of a continuous, wearable progesterone monitor. Our team has sided with using bio-impedance based aptasensors as the current means of achieving this goal (see science section below). Our interest in aptamers is due to their modular nature, expanding user base, versatility, safety, simplicity, and low entry cost1. This technology has several potential applications, due to progesterone levels’ time-dependent variability2 and their link to female health, including the fertility window3, menopause4 and women’s cancer5. Our team is focused on using this technology to illuminate early pregnancy and miscarriage, which has historically been shrouded in stigma (see home page) and continues to harbor important knowledge gaps6.

Miscarriage is relatively common, with approximately 1 million pregnancies per year ending in miscarriage in the United States6. Although about half of these miscarriages are due to well-understood genetic abnormalities7, a significant portion of the remaining miscarriages are not well understood6,8. As a key, variable female sex hormone involved in pregnancy and miscarriage3,5,9, progesterone is poised to provide additional insights into miscarriages when monitored at sufficient frequency and accuracy. Currently, progesterone is monitored through blood draws or urine tests10, which limits the regularity, frequency, and ease with which these tests can be administered3. Developing a continuous progesterone monitor would add a new dimension to women’s health research, allowing for improved research in women’s health and miscarriage.

Some specific potential outcomes are a better picture of individual and chronological variability of progesterone levels during early pregnancy, a better understanding of the chronological link between progesterone levels and miscarriage, and leading miscarriage prediction, detection and classification capabilities. Providing these capabilities directly to women rather than through a medical provider is valuable. More information will create more advocacy for women to allow women to take ownership of their own health. Through our interviews and online research, we have found that women often are not seen by medical providers until 10 weeks into their pregnancy11, by which point many miscarriages will already have occurred12, possibly without their awareness13. Studies have shown that the blood concentration of progesterone is related to the rate of miscarriage14. By creating a wearable continuous progesterone monitor, we hope to continuously monitor precise levels of progesterone to inform pregnant women on the health of their pregnancies. Although our tool alone is not enough to completely demystify the phenomenon or to remove the historical stigma surrounding it, we believe it will

  • provide researchers with a new dimension of data collection, facilitating novel research in the areas of early pregnancy and miscarriage
  • provide women with information, education, and a means of self-monitoring, self-advocacy, and empowerment during early pregnancy and miscarriage
  • serve to drive additional advances in women’s health research and technology

Although we didn’t begin the year with these aspirations (see our Journey section below), we feel the problem is a natural fit and aligns well with the unique aspects of our team. We are students at Brigham Young University, part of the educational system of The Church of Jesus Christ of Latter-day Saints. The Church and we as members deeply value the ability of couples who so desire to participate in the sacred process of procreation and childbirth and to start healthy, happy families15. Many women, locally16 and globally17, want to have families, but forces outside of their control such as fertility problems or repeated miscarriage delay biological childbirth or put it out of reach entirely, resulting in profound emotional pain. We want to help in some small way to end that pain. We see this project as a means to help these and other women create the families they desire.

Science

Early in the year, we decided on aptamer-based detection as our method of choice, due to its versatility, cost-effectiveness, and cell-free nature. Based on our conversations with an aptamer expert and our PI, we felt that an important step in our progress towards building an aptasensor was our independent validation of the aptamer’s binding affinity (KD) with the desired target. This validation would provide us with experience in confidence that our aptamer was sensitive and specific enough to be useful in an aptasensor, and provide us with needed lab experience, given that aptamers are not frequently utilized at BYU and are not an area of expertise for our PI, Jared Barrott. Prioritizing validation led us to perform a fluorophore-quencher affinity assay with our selected PFOA aptamer (PFOA_JYP_2)18, and later, after a pivot in our population of interest and target molecule, to validate our selected progesterone aptamer (P4G03)19’s binding affinity. Due to this aptamer’s different mode of activity (bio-impedance instead of fluorescence) we chose to validate KD and confirm conformational change through isothermal titration calorimetry and circular dichroism.

Simultaneously, we have worked to develop necessary technical components and expertise to facilitate the development of actual aptasensors using these sequences. When focused on the fluorescent PFOA aptamer system, we developed a working fluorescent monitoring system and custom microfluidic chip to measure environmental concentrations of PFOA. Once we transitioned to the bio-impedimetric progesterone aptamer system, we shifted focus to the use of gold electrodes and AC voltammetry to measure the progesterone induced voltage changes. Obtaining this aptamer with required electrochemical modifications was time consuming, so our time for experimentation was limited, but after three experiments, we have been able to witness electrical signals due to high concentrations of progesterone using AC voltammetry. We are currently troubleshooting the chemical procedures for attachment to the electrode and the use of our specific hardware setup in order to optimize our signal to noise ratio and to keep the aptamer active on the electrode surface for as long as possible.

Journey

As part of the Crocker Innovation Fellowship at Brigham Young University, our team was given the goal to create an Internet of Things (IOT) device that would be scalable and marketable while meeting the deeply felt needs of an under-served population. We were taught starting in January 2025 that picking an initial population to investigate, and getting to know their needs, pains, and day-to-day inconveniences can often lead the curious listener to a problem worth solving.

(Visual)

Many of our team members have family or acquaintances that are firefighters, in either urban or wildland settings, so we began investigating their experiences through internet research and interviews with firefighters, chiefs, and researchers to see what pains we could address. Outside of the immediate danger of getting burned, the long-term consequences of firefighting we discovered involved greatly amplified cancer risk due to environmental toxicity. Firefighters have the highest rate of death from cancer than any other groups in part because of their constant exposure of PFOA contained in smoke. In February, we decided to address this issue by creating a device that would serve as a continuous monitor of airborne PFOA (a specific carcinogen impacting firefighters) levels. Aptamers were decided on as the ideal biosensor to address this problem due to their cell-free nature, versatility, cost effectiveness, and continuous monitoring capabilities.

During our research and development on our carcinogen biosensor and our additional human practices research (see human practices page), we began to sense a need to pivot. We observed that although firefighters were aware of and in many cases stressed about the risk of developing cancer, many of the firefighters we interviewed did not value routine cleaning procedures and other prescribed safety practices designed to reduce this risk enough to fully comply. Some of our team were frustrated that firefighters seemed to be more interested in measuring their personal hormones than carcinogens.

We faced technical uncertainty on the best way to measure cumulative carcinogen exposure using aptamers in a way that would be both comprehensive and hassle-free. We also identified competitors - a 2023 iGEM team (FluoroLoop, DTU-Denmark) had used aptamers to detect PFOA20, and another independent researcher had found an abiotic method for airborne PFOA measurement that would likely render our product obsolete. As entrepreneurship in under-served spaces is an important part of the Crocker Innovation Fellowship, we felt it was appropriate to pivot.

For a while, we explored the idea of using synthetic biology to continuously measure heavy metal levels in groundwater. This would help large, corporate mines in the United States to comply with federal monitoring regulations. However, we found that our abiotic competitors21,22 were too advanced, and although biological sensors had some advantages such as potentially small size and portability, making a dent in the industry using synthetic biology would require a larger investment in research and development than we could afford. After intense discussion and several presentations from team members on prospective research avenues, we found progesterone monitoring for the purpose of miscarriage detection to be a compelling problem, under-served population, and relatively feasible research direction.

Although we still face technical uncertainty and have identified adjacent technologies that could represent competitors (Ava23 and Mira24), we feel that our solution would provide a technical edge through direct and continuous progesterone monitoring, something not seen currently on the market. Additionally, we have identified target research grants and other sources of investment that might allow us to surpass our current technical limitations through the acquisition of new resources, tools, perspectives, and experience.

References

For this page

  1. Thiviyanathan, V. & Gorenstein, D. G. Aptamers and the Next Generation of Diagnostic Reagents. Proteomics Clin. Appl. 6, 563–573 (2012).
  2. Nakajima, S. T., McAuliffe, T. & Gibson, M. The 24-hour pattern of the levels of serum progesterone and immunoreactive human chorionic gonadotropin in normal early pregnancy. J. Clin. Endocrinol. Metab. 71, 345–353 (1990).
  3. Wegrzynowicz, A. K., Eyvazzadeh, A. & Beckley, A. Current ovulation and luteal phase tracking methods and technologies for fertility and family planning: a review. Semin. Reprod. Med. 42, 100–111 (2024).
  4. Regidor, P.-A. Progesterone in Peri- and Postmenopause: A Review. Geburtshilfe Frauenheilkd. 74, 995–1002 (2014).
  5. Nagy, B. et al. Key to Life: Physiological Role and Clinical Implications of Progesterone. Int. J. Mol. Sci. 22, 11039 (2021).
  6. Courtney Norris, Rachel Liesendahl, & Casey Kuhn. Why little is known about what causes many pregnancies to end in miscarriage. PBS News https://www.pbs.org/newshour/show/why-little-is-known-about-what-causes-many-pregnancies-to-end-in-miscarriage (2024).
  7. Genomics, F. L. & Gunn, S. The genetics of miscarriage. Front Line Genomics https://frontlinegenomics.com/the-genetics-of-miscarriage/ (2021).
  8. Rafiquddin, S. There’s a knowledge gap about miscarriages in the U.S., and researchers hope to close it. STAT https://www.statnews.com/2024/08/21/miscarriages-poor-data-researchers-explore-causes/ (2024).
  9. Feferkorn, I. & Tulandi, T. The role of progesterone in miscarriage. 66, (2021).
  10. Cable, J. K. & Grider, M. H. Physiology, Progesterone. in StatPearls (StatPearls Publishing, Treasure Island (FL), 2025).
  11. Your First Prenatal Appointment: What to Expect. Boston Medical Center https://www.bmc.org/departments/obstetrics-and-gynecology/patient-resources/first-prenatal-visit.
  12. What you should know about miscarriage signs, early miscarriage and more | Cultivating Health. cultivating-health https://health.ucdavis.edu/blog/cultivating-health/what-you-should-know-about-miscarriage-signs-causes-and-more/2024/07.
  13. Missed miscarriage. The Miscarriage Association https://www.miscarriageassociation.org.uk/information/miscarriage/missed-miscarriage/.
  14. Gong, Y. et al. Can single progesterone concentration predict miscarriage in early pregnant women with threatened miscarriage: a systematic review and meta-analysis. BMC Pregnancy Childbirth 24, 133 (2024).
  15. The Family Proclamation. https://www.churchofjesuschrist.org/study/eng/scriptures/the-family-a-proclamation-to-the-world/the-family-a-proclamation-to-the-world.
  16. About Us. Share Parents of Utah https://sputah.org/about-us/ (2020).
  17. The unacceptable stigma and shame women face after baby loss must end. https://www.who.int/news-room/spotlight/why-we-need-to-talk-about-losing-a-baby/unacceptable-stigma-and-shame.
  18. Park, J., Yang, K.-A., Choi, Y. & Choe, J. K. Novel ssDNA aptamer-based fluorescence sensor for perfluorooctanoic acid detection in water. Environ. Int. 158, 107000 (2022).
  19. Li, Z., Zhang, S., Yu, T., Dai, Z. & Wei, Q. Aptamer-Based Fluorescent Sensor Array for Multiplexed Detection of Cyanotoxins on a Smartphone. Anal. Chem. 91, 10448–10457 (2019).
  20. FluoroLoop | DTU-Denmark. https://2023.igem.wiki/dtu-denmark/.
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  24. Mira Fertility Tracker - Accurate Fertility Tracking and Monitoring. Mira Fertility Shop https://shop.miracare.com/.

All references

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  4. Li, Z., Zhang, S., Yu, T., Dai, Z. & Wei, Q. Aptamer-Based Fluorescent Sensor Array for Multiplexed Detection of Cyanotoxins on a Smartphone. Anal. Chem. 91, 10448–10457 (2019).
  5. Jiménez, G. C. et al. Aptamer-Based Label-Free Impedimetric Biosensor for Detection of Progesterone. ACS Publications https://pubs.acs.org/doi/pdf/10.1021/ac503639s (2015) doi:10.1021/ac503639s.
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  8. S.L, A. W. Ava Fertility Tracker. AvaWomen https://www.avawomen.com/.
  9. S.L, A. W. Ava: A Fertility Tracking Bracelet Unlike Anything Else. AvaWomen https://www.avawomen.com/order-fertility.
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  16. Wegrzynowicz, A. K., Eyvazzadeh, A. & Beckley, A. Current ovulation and luteal phase tracking methods and technologies for fertility and family planning: a review. Semin Reprod Med 42, 100–111 (2024).
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