A Revolutionary Step in Male Infertility: Predicting mTESE Success with our Epigenetic-based Test

American Urological Association (AUA) News reports best posters of 2023

As innovators dedicated to understanding and addressing male infertility, we've been acutely aware of the challenges faced by millions of men. In the U.S. alone, approximately 7 million men grapple with infertility, accounting for nearly half of all infertility cases. Despite the vastness of the global fertility market, there's a glaring deficiency: the limited diagnostic tests available for male fertility. This gap has resulted in countless men being underdiagnosed, leading to unnecessary invasive procedures for their partners and a lack of clarity about the broader health implications tied to male reproductive health.

One of the most perplexing conditions we've encountered in our work is nonobstructive azoospermia (NOA). This condition, affecting about 1% of men worldwide, presents with no visible sperm in the semen without any discernible obstruction in the urogenital tract. For these men, the microscopic testicular sperm extraction (mTESE) procedure has been a beacon of hope, allowing for the retrieval of sperm directly from the testes for IVF treatments. However, the challenges with mTESE are manifold. It's invasive, comes with a hefty price tag, and disappointingly, has a 40%-50% failure rate.

The core issue we aimed to address? The absence of reliable tools to predict mTESE success, which often leads to unsuccessful procedures, emotional turmoil, and escalating medical expenses.

At AUA2023, we were excited to share our latest findings. We've developed a noninvasive, semen-based technique that can predict the presence or absence of sperm in the testicles of men with NOA. Our method hinges on the identification of sperm-derived cell-free DNA through specific DNA methylation patterns that are unique to sperm. Using the cutting-edge Nanopore MinION DNA sequencer, we meticulously analyzed testicular biopsy samples. Our results revealed a compelling correlation between sperm-derived DNA percentages and the actual presence of sperm in the testicles.

Our analysis of semen samples further solidified our findings. We observed that men with less than 5% sperm-derived DNA in their seminal plasma had a 0% success rate of sperm extraction. Conversely, those with more than 25% sperm-derived DNA experienced a 60% success rate.

While we recognize the need for analyzing more samples for a holistic understanding, our initial data is undeniably promising. We believe our epigenetic-based test has the potential to transform the landscape of male infertility, offering a noninvasive means to predict mTESE success and saving countless men from the emotional and financial strain of unnecessary procedures.

We're at the cusp of a new era in reproductive technology, and we're deeply committed to pushing the boundaries further. Our research is not just about numbers and data; it's about giving hope to millions of men and their families worldwide. The future of male fertility diagnostics and treatment is unfolding, and we're honored to be at the forefront of this exciting journey.

Read the AUA News article by clicking here: AUA News

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Unveiling the Power of Epigenetics in Male Fertility: A New Horizon Beyond Semen Analysis

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Inherent Biosciences Receives $1.9 Million NIH Grant to Advance Fertility Solutions