Abstract
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. Subsequent 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.
Highlights
Infertility treatment prior to 1978 proved challenging to both patients and their physicians
With in vitro fertilization (IVF)’s successful introduction, related and supportive technologies soon emerged including IVF and the use of donor eggs, cryopreservation and frozen embryo transfer (FET), gamete intra-fallopian transfer (GIFT), zygote intra-fallopian transfer (ZIFT), intra-cytoplasmic sperm injection (ICSI) and less invasive procedures aided by enhancements in equipment, such as transvaginal ultrasound guided oocyte retrieval
While cumulative pregnancy rates increase with increasing cycle number, per cycle IVF success rates tend to decrease with increasing cycle number
Summary
Infertility treatment prior to 1978 proved challenging to both patients and their physicians. It may be hard to recall that technologies such as IVF, the use of donor eggs, and ICSI were, at first, controversial but so successful in improving outcomes that they were most often adopted into clinical practice without any demonstrated benefit in randomized controlled clinical trials [2]. A patient population exists that will fail to respond to all lines of treatment, including repeated cycles of IVF. For this patient population, IVF using a donor egg or adoption have, until recently, represented the only remaining option(s) [4]. 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. This report represents the earliest global observations of the AUGMENTSM treatment in routine clinical practice from two distinct international centers
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