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At age 27, Amy Beckley and her husband, Jason Beckley, then 31, started trying to conceive their first child. After struggling for months, they visited a doctor who told them they had to try for a minimum of 12 months or suffer at least three miscarriages before they could be treated for infertility.
Beckley, who currently lives in Erie, Colorado, but was based in Apex, North Carolina at the time, says she was forced into a period of “just wait and see.” By the time she was eligible for treatment, she’d suffered two miscarriages and was essentially told her only option was in vitro fertilization (IVF). Three years after they began their journey, their son Cash was conceived on their second round of IVF, a process Beckley describes as both financially and emotionally “draining.”
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So when the California native wanted to conceive again, she opted for a different solution of her own design. Using her background as a scientist who studies hormone signaling—essentially, how organs communicate within the body using hormones—Beckley hypothesized that her infertility had a simple explanation: inadequate levels of progesterone, a hormone released after ovulation that prepares the uterus for implantation. She requested progesterone supplements from her doctor, and after taking them, got pregnant with her daughter Dylan in about three months.
Though Beckley, who holds a PhD in pharmacology from the University of Colorado Health Sciences Center (now the University of Colorado Anschutz Medical Center), can’t say with 100 percent certainty that low progesterone levels caused her infertility, the experience inspired her to ask: How can I create something that allows women to test progesterone at home?
After conducting rudimentary, proof-of-concept science experiments in her basement, consulting infertility experts, and fundraising $45,000 on Indiegogo, Beckley launched Proov, an FDA-cleared, at-home test kit that measures progesterone levels through urine, in February 2017. With Proov, Beckley hopes to give other women important information about their health—information she wishes she had known years earlier.
According to Beckley, who is now 39, and her co-founder Ellen Schell, their company, Boulder-based MFB Fertility, Inc., has sold more than 1,200 Proov kits since the product launched. Because progesterone is produced post ovulation, Proov can help a woman learn whether or not she actually ovulated. “Not ovulating is a very common reason for infertility,” says William Schoolcraft, M.D., founder and medical director of Colorado Center for Reproductive Medicine. Proov can also help identify women who may indeed ovulate, but then not produce enough progesterone after the fact to support a pregnancy; Schoolcraft, who is not involved with Proov, says about 10 percent of his patients fall into this camp.
Using Proov is “very easy,” Beckley says. Women collect first morning urine in a cup, dip a test strip, wait five minutes, and then read the results. One line means the woman has the minimal amount of progesterone needed to support pregnancy (a serum progesterone level of 10 nanograms per milliliter, a threshold that Beckley says is agreed upon by most doctors, including Schoolcraft), and two lines means she’s at risk for low progesterone.
“We want women to be empowered with the information up front and be able to take the test at home before they go through months, years, plus, of disappointing pregnancy test results, losses, etcetera,” says Schell, 37, who also serves as the company’s chief marketing officer.
Beckley says that she didn’t receive information about her progesterone levels before undergoing IVF. However, Schoolcraft says testing progesterone levels, at least at his clinics, is standard “long before” a woman gets to IVF. And Shvetha M. Zarek, M.D., reproductive endocrinologist and assistant professor of obstetrics and gynecology at University of Missouri Health Care, says in many cases, her patients have already had their progesterone levels checked by a general practitioner or OB-GYN before arriving in her office.
Beckley hopes that Proov will help more women gain access to this information, regardless of their doctors’ protocols. The intent, she explains, is that women who are at-risk for low progesterone can then take those findings to a doctor and talk about solutions. And for women with adequate levels? At least they can rule out one possible cause of their infertility.
Schoolcraft, however, struggles to see the benefit of Proov. He points out that women taking Proov tests would probably end up at the doctor regardless of their results. If their progesterone levels tested low, for example, they would want to talk to their doctor about how to raise them (and their doctor, Schoolcraft adds, would probably want to re-test their progesterone levels with a blood draw). And if their progesterone levels were adequate, they would also want to talk to their doctor to figure out the root of their infertility.
“I think the advantage of the home test is if it gives you information that circumvented the need to go to the doctor and spend the money on care—I guess that would be helpful,” says Schoolcraft. “But I’m not sure [Proov] does it.”
Nonetheless, the company is already generating buzz. In May 2018, MFB received a $250,000 grant from the state of Colorado to continue its work, says Schell, and last month, the company participated in a global “Startup of the Year” competition where they ranked in the top 15 of 100 semifinalists. Currently, Beckley and Schell are working with a reproductive endocrinologist to digitize the product into an app that could provide quantitative results (versus just a positive or negative), which they hope to launch next year. As of now, the product is sold in seven-packs on Amazon and ProovTest.com for $39.99.
Looking ahead, both Schell and Beckley hope to educate more women on the importance of progesterone. “Every woman knows what estrogen is, right?” Beckley says. “Every woman should know what progesterone is.”
Editor’s note, 3/16/20: This article was updated when Proov received FDA clearance.