Innovation in IVF and Reproductive medicine: Engineering the future of Reproductive Medicine
Fertilo represents a significant advancement in reproductive medicine, offering a less invasive and potentially more cost-effective alternative to traditional IVF methods.
Revolutionary breakthrough: iPSC-based IVF therapy reaches Phase 3
The Gameto Fertilo breakthrough:. The FDA’s approval for the first US-based Phase 3 clinical trial using induced pluripotent stem cells marks a historic milestone in reproductive medicine, with this groundbreaking milestone highlighting the potential of iPSC technology to address critical unmet needs in reproductive medicine.
Core Technology and Mechanism
Fertilo leverages induced pluripotent stem cells (iPSCs) to mature eggs outside the body, eliminating the need for high-dose hormonal stimulation cycles. The cornerstone of innovation lies in utilizing REPROCELL’s StemRNA™ Clinical Seed iPSCs to engineer ovarian support cells (OSCs) with high purity and potency. Unlike traditional methods requiring 10-14 days of high-dose hormonal stimulation, Fertilo uses engineered, young ovarian support cells to recreate the natural egg maturation process in a dish by co-culturing immature eggs with proprietary ovarian support cells.
Manufacturing Process: The technology utilizes REPROCELL’s footprint-free RNA reprogramming technology manufactured in accordance with ICH 5QA process, generating cells compliant with US FDA, European EMA, and Japanese PMDA regulations. Gameto developed a clinical-grade manufacturing process using GMP-grade raw materials and commercial-grade hiPSC lines to yield highly scalable, consistent, and potent OSC production for clinical use.
Clinical Performance Data
Phase 1/2 Results: Recent Phase 2 data from a 40-patient cohort demonstrated that eggs matured with Fertilo achieved a 70% maturation rate compared to 52% using standard in vitro maturation (IVM). The rate of producing euploid blastocysts was 10% per egg with Fertilo, compared to only 2% with standard IVM.
Pregnancy Outcomes: Fertilo-supplemented mini stimulation cycles resulted in a 44% pregnancy rate per cycle after first transfer, more than double the 20% achieved with conventional IVM. Notably, 8 out of 10 Fertilo patients had at least one viable, euploid embryo suitable for implantation, compared to only 3 out of 10 using standard IVM.
Treatment Efficiency: This process replaces 80% of hormone injections required with traditional IVF and reduces treatment cycle duration to just 2-3 days, offering patients a more comfortable and less invasive experience while significantly reducing risks such as ovarian hyperstimulation syndrome.
Global Regulatory Landscape
International Approvals: Gameto has secured regulatory clearance in Australia, Japan, Argentina, Paraguay, Mexico, and Peru, with a strategic partnership announced with IVFAustralia, part of the Virtus Health group, to bring Fertilo to broader patient populations.
Phase 3 Trial Design: The phase 3 trial will evaluate efficacy and safety across 15 sites in the United States, assessing key outcomes including embryo development, pregnancy rates at 12 weeks (primary endpoint), maternal health, and live birth rates as safety endpoints. The protocol involves up to two days of hormonal injection stimulation with up to two embryo transfers.
Clinical Applications and Implications
Precision Medicine Approach: Research presented at ESHRE 2024 demonstrated that crosstalk between OSCs and immature oocytes contributes to an improved in vitro environment that helps oocytes mature as they would naturally in the body, with bidirectional signaling resulting in improved oocyte gene expression.
Economic Impact: The company suggested that Fertilo could reduce costs by several thousand dollars per average IVF cycle or egg-freezing procedure, potentially democratizing access to fertility treatments.
Future Applications: Beyond fertility treatment, Gameto’s technology platform opens possibilities for addressing reproductive health challenges through cell engineering-inspired innovation, with broader applications including menopause and ovarian cancer treatment.
Clinical implications: This represents a paradigm shift toward precision medicine in reproductive care, with the ability to mature eggs outside the body with minimal hormonal intervention significantly reducing risks such as ovarian hyperstimulation syndrome and alleviating side effects caused by high hormone doses. The technology addresses the physical, emotional, and financial burden of traditional IVF while maintaining superior clinical outcomes.
References
Piechota S, Marchante M, Giovannini A, et al. Human-induced pluripotent stem cell-derived ovarian support cell co-culture improves oocyte maturation in vitro after abbreviated gonadotropin stimulation. Hum Reprod. 2023;38(12):2456-2469. doi:10.1093/humrep/dead205
Paulsen B, Piechota S, Barrachina F, et al. Rescue in vitro maturation using ovarian support cells of human oocytes from conventional stimulation cycles yields oocytes with improved nuclear maturation and transcriptomic resemblance to in vivo matured oocytes. J Assist Reprod Genet. Published online May 30, 2024. doi:10.1007/s10815-024-03143-4
Innovation in IVF and Reproductive medicine: Engineering the future of Reproductive Medicine
Fertilo represents a significant advancement in reproductive medicine, offering a less invasive and potentially more cost-effective alternative to traditional IVF methods.
Revolutionary breakthrough: iPSC-based IVF therapy reaches Phase 3
The Gameto Fertilo breakthrough:. The FDA’s approval for the first US-based Phase 3 clinical trial using induced pluripotent stem cells marks a historic milestone in reproductive medicine, with this groundbreaking milestone highlighting the potential of iPSC technology to address critical unmet needs in reproductive medicine.
Core Technology and Mechanism
Fertilo leverages induced pluripotent stem cells (iPSCs) to mature eggs outside the body, eliminating the need for high-dose hormonal stimulation cycles. The cornerstone of innovation lies in utilizing REPROCELL’s StemRNA™ Clinical Seed iPSCs to engineer ovarian support cells (OSCs) with high purity and potency. Unlike traditional methods requiring 10-14 days of high-dose hormonal stimulation, Fertilo uses engineered, young ovarian support cells to recreate the natural egg maturation process in a dish by co-culturing immature eggs with proprietary ovarian support cells.
Manufacturing Process: The technology utilizes REPROCELL’s footprint-free RNA reprogramming technology manufactured in accordance with ICH 5QA process, generating cells compliant with US FDA, European EMA, and Japanese PMDA regulations. Gameto developed a clinical-grade manufacturing process using GMP-grade raw materials and commercial-grade hiPSC lines to yield highly scalable, consistent, and potent OSC production for clinical use.
Clinical Performance Data
Phase 1/2 Results: Recent Phase 2 data from a 40-patient cohort demonstrated that eggs matured with Fertilo achieved a 70% maturation rate compared to 52% using standard in vitro maturation (IVM). The rate of producing euploid blastocysts was 10% per egg with Fertilo, compared to only 2% with standard IVM.
Pregnancy Outcomes: Fertilo-supplemented mini stimulation cycles resulted in a 44% pregnancy rate per cycle after first transfer, more than double the 20% achieved with conventional IVM. Notably, 8 out of 10 Fertilo patients had at least one viable, euploid embryo suitable for implantation, compared to only 3 out of 10 using standard IVM.
Treatment Efficiency: This process replaces 80% of hormone injections required with traditional IVF and reduces treatment cycle duration to just 2-3 days, offering patients a more comfortable and less invasive experience while significantly reducing risks such as ovarian hyperstimulation syndrome.
Global Regulatory Landscape
International Approvals: Gameto has secured regulatory clearance in Australia, Japan, Argentina, Paraguay, Mexico, and Peru, with a strategic partnership announced with IVFAustralia, part of the Virtus Health group, to bring Fertilo to broader patient populations.
Phase 3 Trial Design: The phase 3 trial will evaluate efficacy and safety across 15 sites in the United States, assessing key outcomes including embryo development, pregnancy rates at 12 weeks (primary endpoint), maternal health, and live birth rates as safety endpoints. The protocol involves up to two days of hormonal injection stimulation with up to two embryo transfers.
Clinical Applications and Implications
Precision Medicine Approach: Research presented at ESHRE 2024 demonstrated that crosstalk between OSCs and immature oocytes contributes to an improved in vitro environment that helps oocytes mature as they would naturally in the body, with bidirectional signaling resulting in improved oocyte gene expression.
Economic Impact: The company suggested that Fertilo could reduce costs by several thousand dollars per average IVF cycle or egg-freezing procedure, potentially democratizing access to fertility treatments.
Future Applications: Beyond fertility treatment, Gameto’s technology platform opens possibilities for addressing reproductive health challenges through cell engineering-inspired innovation, with broader applications including menopause and ovarian cancer treatment.
Clinical implications: This represents a paradigm shift toward precision medicine in reproductive care, with the ability to mature eggs outside the body with minimal hormonal intervention significantly reducing risks such as ovarian hyperstimulation syndrome and alleviating side effects caused by high hormone doses. The technology addresses the physical, emotional, and financial burden of traditional IVF while maintaining superior clinical outcomes.
References
Piechota S, Marchante M, Giovannini A, et al. Human-induced pluripotent stem cell-derived ovarian support cell co-culture improves oocyte maturation in vitro after abbreviated gonadotropin stimulation. Hum Reprod. 2023;38(12):2456-2469. doi:10.1093/humrep/dead205
Paulsen B, Piechota S, Barrachina F, et al. Rescue in vitro maturation using ovarian support cells of human oocytes from conventional stimulation cycles yields oocytes with improved nuclear maturation and transcriptomic resemblance to in vivo matured oocytes. J Assist Reprod Genet. Published online May 30, 2024. doi:10.1007/s10815-024-03143-4
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