New Tech Could Make IVF Safer and Cut Treatment Time in Half
In a significant advancement for reproductive medicine, Gameto has announced the launch of its Phase 3 clinical trial for Fertilo, an innovative in vitro maturation (IVM) solution designed to mature eggs outside the body. This development aims to make in vitro fertilization (IVF) and egg freezing procedures shorter, safer, and more accessible for individuals and couples facing fertility challenges.
Gameto's Fertilo Could Make IVF Safer and Cut Treatment Time in Half
In a groundbreaking step forward for fertility treatments, Gameto has launched a Phase 3 clinical trial for Fertilo, a first-of-its-kind induced pluripotent stem cell (iPSC)-based therapy designed to revolutionize in vitro fertilization (IVF). This cutting-edge approach could shorten the IVF process, reduce the need for hormone medications, and improve patient outcomes, marking a major advancement in reproductive medicine.
What Is Fertilo?
For decades, standard IVF has relied on weeks of hormone injections to stimulate the ovaries before retrieving eggs. Gameto’s Fertilo offers a potential alternative—maturing eggs outside the body using lab-grown ovarian support cells. This technology is designed to replace hormonal injections and shorten the in vitro fertilization (IVF) and egg freezing cycle from 10-14 days to 2-3 days, potentially requiring 80% fewer hormonal injections than traditional IVF methods.
Following FDA Investigational New Drug (IND) clearance, Gameto is now moving forward with its pivotal Phase 3 trial across multiple U.S. sites. The trial will assess Fertilo’s ability to improve embryo quality and pregnancy rates, with pregnancy at 12 weeks as the primary efficacy endpoint. Secondary assessments will investigate embryo development, maternal health and live birth rates.(Clinical Trials Arena).
A First in IVF History
Fertilo is the first-ever iPSC-derived therapy to reach a Phase 3 fertility trial in the U.S.. By harnessing the power of cell engineering, Fertilo uses lab-grown ovarian support cells (OSCs) to mature eggs outside the body—a process that mimics natural egg maturation but in a controlled environment (Gameto).
“By overcoming the major challenges of conventional IVF such as long treatment cycles, significant side effects, and the emotional and physical strain, Fertilo provides a potentially faster, safer, and more accessible solution for families. This milestone marks a turning point in reproductive health and highlights the first application of iPSC technology in IVF and the immense potential of our technology,” said Gameto co-founder Dina Radenkovic.
Who Could Benefit from Fertilo>
With 1 in 3 women experiencing ovarian hyper-stimulation syndrome (OHSS), a painful and potentially dangerous response to stimulation during IVF, IVFM could be a very valuable option for those at risk. OHSS takes place when a women’s body over-responds to the hormone medications (notably injectable gonadotropins) used to stimulate egg development during a fertility treatment cycle.
According to ASRM, in vitro maturation (IVM) has historically been an option for patients at risk of ovarian hyperstimulation syndrome (OHSS), including those with PCOS or polycystic ovary-like ovaries, as well as individuals with estrogen-sensitive cancers. Since IVM requires significantly less medication, fewer injections, and less monitoring, it can help reduce both the financial and emotional burden compared to traditional IVF. It may also be a fertility-preserving option for those facing gonadotoxic cancer treatments or individuals experiencing repeated IVF failure due to resistant ovary syndrome.
What’s Next for Fertilo?
The Phase 3 trial will be the final step before Fertilo seeks FDA approval for widespread use in fertility clinics. For the millions of people navigating infertility, this could offer a less invasive, more efficient path to parenthood. If successful, this innovation could mean:
✅ Fewer hormone injections
✅ Shorter IVF cycles
✅ Potentially higher-quality embryos
✅ Greater accessibility to fertility treatments
“Gameto’s technology platform opens entirely new possibilities for addressing reproductive health challenges through cell engineering-inspired innovation.
“With Fertilo, we’ve demonstrated the potential of iPSC-based therapies to redefine fertility care by targeting ovarian health at the cellular level. This milestone also highlights the power of iPSCs in regenerative medicine and our computational and cell engineering platform where we have broader applications including menopause and ovarian cancer,” explained Gameto’s chief scientific officer Christian Kramme.
As Fertilo progresses through clinical trials, it holds the promise of transforming IVF treatments by reducing the physical and emotional burdens associated with traditional IVF methods. By making fertility treatments more efficient and less taxing, Gameto aims to provide new hope to those on their journey to parenthood.
We've been closely following the research on this technology and are eager to see what Phase 3 reveals. The science is fascinating and has the potential to make a real impact, especially for a specific group of fertility patients. Would you consider trying an IVF cycle with lab-matured eggs?
References:
American Society for Reproductive Medicine. (2021). In vitro maturation: A committee opinion. Retrieved from https://www.asrm.org/practice-guidance/practice-committee-documents/in-vitro-maturation-a-committee-opinion-2021/
Clinical Trials Arena. (2024, January 29). Gameto launches Phase III iPSC fertility trial following IND greenlight. Retrieved from https://www.clinicaltrialsarena.com/news/gameto-launches-phase-iii-ipsc-fertility-trial-following-ind-greenlight/
Medical Disclaimer: The information provided in this blog is intended for general informational purposes only and should not be considered as a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your healthcare provider or qualified medical professional with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read in this blog.
