CCRM issued the following announcement on Nov. 14.
CCRM (Colorado Center for Reproductive Medicine), a global pioneer in fertility science, research and advancement, today announced plans to begin recruitment of patients to participate in an institutional review board (IRB)-approved clinical trial for non-invasive preimplantation genetic testing for aneuploidy (PGT-A). The clinical trial is spearheaded by world-renowned genetic scientist, Mandy Katz-Jaffe, PhD., and will take place at CCRM's facility in Denver, Colorado.
CCRM was the first fertility center to offer PGT-A on a day five or day six embryo back in 2007. PGT-A—also known as comprehensive chromosome screening—is a technique that counts all 23 pairs of chromosomes, performed in conjunction with in vitro fertilization. During this procedure, embryos are cultured in a lab and tested for chromosomal numeration via biopsy, an invasive procedure in which a handful of cells are removed from the developing embryo.
Unlike traditional PGT-A which relies on biopsy, the new non-invasive technique analyzes the DNA in the nutrient-rich solution surrounding the embryo instead of removing cells from the embryo itself. This groundbreaking procedure eliminates the risk of embryo damage, resulting in less manipulation of the embryo. In the R&D phase, IRB-approved, non-invasive PGT-A study of 120 samples, CCRM found 90 percent concordance with biopsy results after testing.
With approximately 70 percent of spontaneous miscarriage due to the presence of an abnormal number of chromosomes, PGT-A is recommended for women age 35 and older, whose eggs are at increased risk for chromosome errors, and for women with a history of multiple miscarriages. CCRM's PGT-A success rates are some of the highest in the nation, including a significant reduced risk of miscarriage (less than five percent) and increased live birth rates, maternal age independent. Through CCRM's efforts, more than 4,500 healthy babies have been born following the transfer of euploid embryos (correct number of chromosomes).
"At CCRM, our team of molecular genetic scientists, embryologists and physicians are dedicated to delivering leading patient outcomes, and our research surrounding non-invasive PGT-A is an integral part of that equation," said Dr. Katz-Jaffe, who serves as CCRM's Scientific and Genetics Director. "Through this clinical trial, we will answer the question, can non-invasive PGT-A replace the current invasive methods for aneuploidy screening and eliminate the risk associated with traditional biopsy techniques. If all goes well this could even improve future implantation rates, while potentially lowering testing costs for our patients. We're incredibly pleased to begin this clinical trial and look forward to sharing our findings with the medical community."
"CCRM continues to make significant investments in research and technology to improve implantation rates, reduce miscarriage rates and improve the chances of a chromosomally normal, live birth," said William Schoolcraft, M.D., founder and medical director of CCRM. "Through developments like non-invasive PGT-A, we're advancing research and development to fight infertility and ultimately succeeding, even with the most complex cases."
CCRM is currently looking for prospective patients to participate in the non-invasive PGT-A clinical trial. For more information on non-invasive PGT-A and to learn how you can participate in the clinical trial, please visit www.ccrmivf.com or contact Rachel Maklowski, Clinical Research Coordinator at rmaklowski@coloccrm.com.
Original source can be found here.
