First-of-its-kind research will explore how vaginal microbiome composition may impact fertility outcomes — offering new hope to millions navigating IVF.
Evvy, a pioneering women’s health startup focused on the vaginal microbiome, today announced the launch of a landmark clinical study exploring the link between the vaginal microbiome and in vitro fertilization (IVF) outcomes. This will be the first-ever study using a validated, commercially available vaginal microbiome test to uncover potential microbial markers linked to IVF success.
The study was designed in collaboration with leading fertility doctors including Dr. David Sable (Life Sciences), Dr. Peter Klatsky (Spring Fertility), Dr. Sara Vaughn (HRC Fertility), and Dr. Eduardo Hariton (Reproductive Science Center), alongside Evvy’s Chief Science Officer, Pita Navarro, and Chief Medical Officer, Dr. Kate McLean. Together, they aim to identify the specific vaginal markers associated with IVF outcomes.
The study is already live with multiple clinics across the country with significant interest from fertility clinics and research institutions to join. Clinics or researchers interested in becoming study sites are encouraged to reach out to participate in this growing collaborative effort to advance the science of fertility.
“Despite doing everything ‘right,’ many IVF patients still face heartbreaking failures without clear explanations,” says 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.”
With roughly 1 in 8 couples facing infertility and average IVF success rates remaining around 30–40% per cycle, there’s a clear and urgent need for more predictive and preventive insights in fertility care. While early research has linked vaginal microbiome disruptions to IVF failure, recurrent pregnancy loss, and preterm birth, those insights have yet to be translated into clinical practice at scale. With this study, Evvy hopes to leverage their unique testing and data platform to finally bridge the gap between research and patient care — providing answers where they didn’t previously exist.
Evvy’s test is CLIA, CAP, and CLEP certified, and validation of the test methodology was published in the peer-reviewed Diagnostics journal. The test can detect 700+ microbes from a single, at-home swab. Through Evvy’s platform, they’ve built the world’s largest dataset on the vaginal microbiome and created a proprietary database with hundreds of novel genomes. Through this proprietary platform, Evvy is uniquely positioned to map key microbial signatures to clinical outcomes.
“Despite decades of progress in reproductive medicine, there’s still so much we’re learning about the underlying biology that contributes to IVF outcomes,” says 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 launch of this study builds on Evvy’s recent release of fertility-focused insights, which enable users to assess and improve their vaginal microbiome before trying to conceive, undergoing IVF, or exploring causes of unexplained infertility. The company aims to build solutions based on what science already knows—and do the research where it has been overlooked. This study is the first of many in Evvy’s pipeline to validate the power of vaginal microbiome testing in predicting a variety of women’s health outcomes throughout the lifespan.
About Evvy
Evvy is closing the gender health gap through novel biomarker discovery in the vaginal microbiome. Evvy’s groundbreaking Vaginal Health Test is the world’s only certified, peer-reviewed vaginal microbiome test to uncover 700+ microbes with a single, at-home swab. Combined with precision treatment pathways and 1-1 coaching, Evvy provides over 50,000 women with data-driven, personalized healthcare for vaginal infections, fertility, menopause, and more. Evvy has built the world’s largest dataset on the vaginal microbiome, and they are pioneering novel research to transform female health outcomes.
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Contacts
Contacts
SolComms
Jessica Bryant
jess@solcomms.co
