Journal of Fertilization: In Vitro - IVF-Worldwide, Reproductive Medicine, Genetics & Stem Cell Biol
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The AUGMENTSM Treatment: Physician Reported Outcomes of the Initial Global Patient Experience

Michael H Fakih, Mohamad El Shmoury, Julia Szeptycki, Dennis B dela Cruz, Caroline Lux, Suleman Verjee, Colleen M Burgess, Gabriel M Cohn and Robert F Casper

Background: Egg precursor cells can be readily isolated from the protective outer lining of the ovarian cortex. Studies have demonstrated that mitochondria isolated from these cells are of high quality. The AUGMENTSM treatment is a proprietary new technology based on previous clinical use demonstrating that the addition of mitochondria during in vitro fertilization (IVF) is safe, improves embryo quality, and increases the success of IVF. Subsequently published animal studies also confirmed the role of mitochondria in improved outcomes. This report represents the earliest global observations of the AUGMENTSM treatment in routine clinical practice from two distinct international centers.

Methods and results: The AUGMENTSM treatment was initially used in a population of difficult-to-treat patients with a poor prognosis for success with standard IVF who were likely moving to donor egg as a next step. Each group reported marked improvements in pregnancy rates above the historic IVF success rate for these patients (e.g., 11- and 18- fold increase in ongoing clinical pregnancy rates in the UAE and Canada, respectively). In a 25 patient subset, retrieved eggs from each woman were allocated to two treatment groups; one group underwent the AUGMENTSM treatment at the time of ICSI while the other group underwent conventional ICSI. Embryos were selected for fresh-embryo transfer based on standard criteria including embryo morphology and the results of preimplantation genetic testing. Morphogenetic embryo selection and transfer from the AUGMENTSM treatment group was significantly higher, suggesting that improved embryo quality may have resulted in the improved pregnancy rates observed in these women.

Conclusions: Based on these findings, the AUGMENTSM treatment may be a viable treatment option to address an unmet need for women with poor reproductive histories, history of poor egg quality, poor embryo development, previously failed IVF, and those seeking—despite repeated failures-to conceive genetically-related offspring.