New diagnostic addresses critical gap in IVF care—measuring whether the uterus is ready to support an embryo
Study shows test accurately identifies patients at risk for failed transfers and those with healthy endometrium, enabling personalized treatment decisions
HOUSTON, Oct. 27, 2025 (GLOBE NEWSWIRE) — Simbryo Technologies, a biotech company improving in-vitro fertilization (IVF) outcomes, announced today the availability of Simbryo FX, a personalized functional assay of endometrial fertility that predicts the likelihood of implantation before embryo transfer.
One in six couples worldwide struggles with infertility, and many turn to IVF. Despite advances in embryo testing, IVF success rates under the best circumstances have plateaued at 65 percent, resulting in a trial-and-error approach to embryo transfer that leads to multiple failures and significant patient frustration.
Many unsuccessful embryo transfers stem from issues with the endometrium, the uterine lining where embryos implant and develop. During a successful implantation, an embryo attaches to the endometrium and produces the hormone human chorionic gonadotropin (hCG), leading to a positive pregnancy test. Current endometrial tests assess endometrial inflammation, harmful bacteria, or altered hormone timing, but they are not effective clinical predictors of endometrial fertility.
Simbryo FX assesses endometrial fertility using a patient’s biopsy tissue to create organoids, three-dimensional models of the endometrium in a culture dish. Blastoids (stem cell-based embryo models resembling the human blastocyst) are implanted in hormone-stimulated organoids to quantify endometrial fertility through hCG levels and imaging.
“When patients talk about embryo transfer, they use gambling analogies like ‘rolling the dice’ and ‘odds of success’. The way that patients find out that they have a problem, versus being unlucky, is through repeated embryo transfer failure. The more times they fail, the higher the likelihood that something is wrong. That is a crazy way to diagnose a medical condition,” said Yael Katz, CEO of Simbryo Technologies. “Pregnancy will never be guaranteed, but when patients are trying to decide whether to make a major investment in another cycle or how to make the most of a few embryos, Simbryo provides answers to help them move forward with hope and confidence. This is personalized medicine for IVF—something the field has desperately needed.”
Clinical research presented at the American Society of Reproductive Medicine (ASRM) Scientific Congress in San Antonio demonstrated that the assay identifies patients with low endometrial fertility with over 90% specificity.
The study, conducted with Texas Fertility Center in Austin and Aspire HFI in Houston, analyzed endometrial biopsies from over 100 patients preparing for frozen embryo transfer. Although relatively rare, endometrial dysfunction can lead to multiple failed cycles. Simbryo FX identified patients with three or more prior failed transfers based on low hCG production in the assay and poor blastoid adhesion to the endometrial organoids. Simbryo FX predicted the outcomes of patients’ next embryo transfer in the clinic: nearly all of those in the low fertility group experienced another failed transfer, and among the remaining patients, assay scores correlated with the likelihood of embryo transfer success.
“When patients experience embryo transfer failure, they want answers. Currently available tests of endometrial health have shown inconsistent results and limited success in improving patient care. The Simbryo platform gives physicians personalized insight into endometrial fertility, enabling them to better guide patients”, said Dr. Madeline Kaye of Texas Fertility Center. “This is huge in reducing the emotional stress associated with a long, uncertain, and high-stakes process.”
“We have made great strides optimizing the embryo side of IVF, but the endometrium has remained much more difficult,” said Dr. George Grunert of Aspire Health Fertility Institute. “Identifying why implantation is not successful and adjusting treatment plans beforehand is groundbreaking. As more patients have access to Simbryo, the data and insights we glean will continue to expand.”
The Simbryo FX platform enables true personalized medicine in IVF. Because organoids are developed from a patient’s own endometrial cells, the results and insights are patient-specific. As adoption grows, Simbryo will expand its data to study and assess possible endometrial fertility treatments in the future.
“What excites me most isn’t just what we’re doing today—it’s where this takes us tomorrow. Now that we can measure endometrial fertility, we can finally start understanding how to improve it. We’re opening the door to treatments and interventions that were impossible before because we simply didn’t have the framework. This is the beginning of a new era in reproductive medicine, and I believe it’s going to transform outcomes for thousands of families,” said Dr. Katz.
Simbryo FX is part of Simbryo’s all-in-one platform, which leverages a single biopsy to run multiple tests for a comprehensive endometrial fertility evaluation during IVF cycles, helping physicians and patients understand the odds before implantation and increase success rates.
The Simbryo FX was developed through a pioneering collaboration with Rice University’s Warmflash Laboratory of Systems Stem Cells and Development Biology in Houston, a leading interdisciplinary research group at the forefront of biology, physics and engineering sciences. The Warmflash Lab spearheaded rigorous validation of the assay’s endometrial fertility application, leveraging its world-class expertise in stem cell systems to confirm its clinical effectiveness.
Following the conference, the poster and the corresponding paper will be made available on Simbryo’s website.
About Simbryo Technologies
Simbryo Technologies is a commercial-stage biotech company accelerating paths to pregnancy via organoid medicine and AI. Working with top research institutions and fertility clinics, Simbryo develops personalized diagnostic platforms that predict and optimize endometrial fertility, giving patients and physicians actionable insights to increase success rates and providing a powerful in-vitro test bed for novel fertility treatments. For more information, visit www.simbryotech.com.
Contact:
Patty Caballero
patty@pscconsulting.net
973-348-5055
