IVF clinical trials USA
Reproductive Medicine Associates of New Jersey, (RMANJ), a world-renowned leader in the field of infertility, announced today the launch of the neXgen Clinical Trial. The objective of the neXgen trial is to assess the clinical impact of next generation sequencing (NGS) based Preimplantation Genetic Diagnosis (PGD) to aid in the selection of embryos for transfer during in vitro fertilization (IVF) cycles. The neXgen clinical trial is a double blind study of 200 IVF patients and one of the first clinical trials using the IonTorrent from Life Technologies for NGS testing.
In this selection vs. non-selection trial, once embryos reach the blastocyst stage of development, each embryo will undergo trophectoderm biopsy and then cryopreservation. During the subsequent frozen embryo transfer cycle, patients within the study group (selection) will have NGS performed using RMANJ’s proprietary assay panel and then two of the morphologically-best euploid embryos transferred. Patients in the control group (non-selection) will have two morphologically-best unscreened embryos transferred.
Known for being at the forefront of several breakthroughs in IVF, RMANJ houses one of the largest IVF research and clinical laboratories in the US. Dr. Richard T. Scott Jr., a founding partner of RMANJ commented on the research, “We have a long track record of validating and adopting different technologies that have benefitted patients from New Jersey and around the world. The issue of aneuploidy is one of the biggest barriers that infertility patients have to face.” Dr. Scott added, “We truly believe that NGS based comprehensive chromosome screening (CCS) has the potential to improve outcomes and lower costs. We’re eager to complete this trial quickly and share our interim results with the scientific community later this year.”
Current methodology using qPCR-based embryo screening platforms offer greater than 98% accuracy in detecting ploidy status. Blastocyst biopsy with rapid qPCR-based comprehensive chromosomal screening results in statistically significantly improved IVF outcomes, as evidenced by meaningful increases in sustained implantation and delivery rates.
However, NGS has the potential to provide gains by improving accuracy and reducing costs associated with genetic screening in IVF which is not typically covered by insurance currently.
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This is consistent with reports from