Evvy partners with fertility clinics to probe link between vaginal microbiome and IVF outcomes
Vaginal microbiome largely overlooked in fertility research
Women’s health startup Evvy is partnering with fertility clinics across the United States to launch a new study investigating the role of the vaginal microbiome in IVF outcomes.
The New York-based company will use its validated, commercially available vaginal microbiome test which can detect 700+ microbes from a single a-home swab. Designed by fertility specialists alongside Evvy’s Chief Science Officer, Pita Navarro, and Chief Medical Officer, Dr Kate McLean, the study aims to identify specific microbial patterns and how they match up with different reproductive outcomes.
Infertility affects around one in eight couples, with IVF offering a potential path to parenthood. Despite advances in technology, the average live birth rate per IVF cycle remains between 30% and 40%, leaving many patients with few answers when treatments fail.
Research has pointed to microbial imbalances as a possible factor in IVF failure, pregnancy loss, and preterm birth, but testing for these imbalances has yet to become part of routine fertility care.
“It is devastating when patients do everything ‘right’ yet still don’t get the results they hoped for,” 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.”
Evvy’s test, certified by CLIA, CAP, and CLEP, detects over 700 microbes from a single at-home swab. Validation of the test methodology has been published in the peer-reviewed journal Diagnostics, and the company has built what it says is the world’s largest dataset on the vaginal microbiome, including hundreds of novel genomes. By combining this database with a broad patient study, Evvy hopes to better understand the connections between microbiome health and reproductive 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 largely overlooked in fertility research, even though emerging evidence suggests it plays a pivotal 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 follows Evvy’s recent introduction of microbiome-based fertility insights for users preparing for conception, IVF, or addressing unexplained infertility.
This will be the first in a series of studies Evvy plans to undertake, aiming to validate vaginal microbiome testing as a predictive tool for a range of women’s health outcomes across the lifespan.