Reproductive Medicine Associates of New Jersey Launches neXgen Clinical Trial; Next Generation Sequencing Approach to In Vitro Fertilization (IVF) Latest clinical trial in US combines RMANJ's proprietary comprehensive chromosome screening methods with genomic sequencing technology to further improve the embryo selection process and success rates in IVF
BASKING RIDGE, N.J., Feb. 4, 2014 /PRNewswire/ -- 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.1
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.
Dr. Marie Werner, of the neXgen clinical trial explains the benefits of embryo screening and NGS, "With our current qPCR based platform of CCS we are able to determine which embryos have the correct balance of chromosomes and which embryos have too many or too few chromosomes. We have already demonstrated in previously published data the benefits of using qPCR- based CCS. NGS technology only adds to the success we have already achieved using qPCR-based CCS. There are only a few clinical trials using NGS in the US right now, so I'm very excited to be a part of this important clinical project."
neXgen can have a significant impact on preimplantation screening as extensive data shows that embryonic aneuploidy (an imbalance of chromosomes) is one of the largest contributing factors in IVF failure or miscarriage, across all age groups. The neXgen clinical trial is part of RMANJ's ongoing commitment to more accurately detect healthy embryos that may increase positive IVF outcomes.
"Genomics is revolutionizing modern medicine," commented Dr. Nathan Treff, Director of Molecular Biology Research at RMANJ. "NGS has the potential to lower the cost of embryonic screening in IVF, opening access for a lot more who could benefit. I'm excited to share some of the most extensive preclinical validation data we've generated already on NGS at the Advances in Genome Biology & Technology (www.AGBT.org) conference next month," added Dr. Treff.
About Reproductive Medicine Associates of New Jersey
Reproductive Medicine Associates of New Jersey have pioneered and successfully implemented a cutting-edge technology, known as Comprehensive Chromosome Screening (CCS). Other centers have attempted similar testing methods, however RMANJ is one of the foremost fertility centers in the world to have developed a system of unprecedented accuracy and validated through years of rigorous clinical research. RMANJ's Comprehensive Chromosome Screening offers advanced embryo selection with extreme accuracy by detecting and avoiding use of embryos with chromosomal abnormalities prior to transfer.
The fertility experts at RMANJ have among the highest IVF success rates in the country. Since 1999, they have helped bring more than 30,000 babies to loving families. In addition to serving as the Division of Reproductive Endocrinology at Rutgers Robert Wood Johnson University Medical School in New Brunswick, NJ, the practice has seven locations in New Jersey. For more information please call RMANJ at 973-656-2089, or visit http://www.rmanj.com.
Scott RT, Jr., Upham K, Forman E, Hong K, Scott K, Taylor D, Tao X, Treff NR. Blastocyst biopsy with comprehensive chromosome screening and fresh embryo transfer significantly increases in vitro fertilitzation implantation and delivery rates; a randomized controlled trial. Fertil Steril 2013
SOURCE Reproductive Medicine Associates of New Jersey