Evvy, a women’s health startup focused on the vaginal microbiome, has launched a clinical study examining the relationship between vaginal microbiome composition and in vitro fertilization (IVF) outcomes, the company announced today.
The research, described as the first to use a validated, commercially available vaginal microbiome test to identify potential microbial markers linked to IVF success, has been designed in collaboration with fertility specialists including Dr. David Sable (Life Sciences), Dr. Peter Klatsky (Spring Fertility), Dr. Sara Vaughn (HRC Fertility), and Dr. Eduardo Hariton (Reproductive Science Center).
“Despite doing everything ‘right,’ many IVF patients still face heartbreaking failures without clear explanations,” said Dr. Kate McLean, Chief Medical Officer at Evvy. “This study could fundamentally enhance our understanding of why some cycles fail — and unlock a new, proactive tool for patients and providers to improve outcomes.”
According to the company, approximately one in eight couples face infertility, with average IVF success rates remaining around 30-40% per cycle. While early research has linked vaginal microbiome disruptions to IVF failure, recurrent pregnancy loss, and preterm birth, these insights have not yet been widely translated into clinical practice.
“Despite decades of progress in reproductive medicine, there’s still so much we’re learning about the underlying biology that contributes to IVF outcomes,” said Pita Navarro, Co-Founder and Chief Science Officer of Evvy. “The vaginal microbiome has been consistently overlooked in fertility research, even as evidence grows around its role in reproductive outcomes. With this study, we hope to generate new insights that deepen our understanding and lay the scientific foundation for future tools to help doctors and their patients make more personalized, informed decisions about care.”
The study is currently active with multiple clinics across the United States, with interest from additional fertility clinics and research institutions to join. Evvy’s test, which has CLIA, CAP, and CLEP certification, can detect over 700 microbes from a single at-home swab. The company states that its validation methodology was published in the peer-reviewed journal Diagnostics.
This study builds on Evvy’s recent release of fertility-focused insights for users to assess their vaginal microbiome before trying to conceive or undergoing IVF.
