What You Should Know:
– Evvy, a women’s health startup focusing on novel female biomarkers, is embarking on a pioneering study in partnership with leading fertility clinics across the United States.
– The landmark research initiative marks the first time a validated, commercially available vaginal microbiome test will be used specifically to predict outcomes for patients undergoing in vitro fertilization (IVF). The study aims to identify key vaginal biomarkers linked to reproductive success, potentially transforming IVF protocols.
Addressing Critical Gaps in IVF Success Rates
Infertility impacts approximately one in eight couples in the U.S., making IVF an increasingly utilized path to parenthood. However, the procedure currently has an average live birth rate of only 30-40% per cycle. This highlights significant gaps in understanding and mitigating factors that can lead to IVF failure before patients undergo the costly and emotionally taxing process. Compounding this, existing scientific research has already indicated connections between imbalances in the vaginal microbiome and reproductive challenges, including IVF failure, recurrent pregnancy loss, and preterm birth.
Leveraging Advanced Microbiome Testing
Evvy aims to bridge the gap between this existing research and clinical patient care. The study utilizes Evvy’s unique vaginal microbiome test, which is CLIA, CAP, and CLEP certified and validated in the peer-reviewed journal Diagnostics. This powerful test can identify over 700 microbes from a single, convenient at-home swab. Evvy has already built the world’s largest dataset related to the vaginal microbiome, including a proprietary database with hundreds of novel genomes. By applying this robust testing platform and dataset to a large patient population within partnered fertility clinics, Evvy seeks to generate actionable evidence.
Potential for Proactive Intervention and Improved Outcomes
The study was meticulously designed by prominent fertility specialists alongside Evvy’s Chief Science Officer, Pita Navarro, and Chief Medical Officer, Dr. Kate McLean. The potential impact could be significant, offering new insights into why some IVF cycles fail despite patients doing everything “right”.
“It is devastating when patients do everything ‘right’ yet still don’t get the results they hoped for,” stated 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”.
Building on Existing Work and Future Research
This major study follows Evvy’s recent introduction of fertility-focused insights within its platform. These insights already allow users to test and understand their microbiome health before conception attempts, IVF procedures, or when investigating unexplained infertility. Evvy’s strategy involves creating solutions based on established science while actively researching areas previously neglected. This IVF study is noted as the first among many planned by Evvy to validate the predictive power of vaginal microbiome testing across a spectrum of women’s health issues throughout their lives.
