Gene Security Network (GSN) announced today that it has initiated enrollment for a prospective randomized trial in collaboration with Ferring Pharmaceuticals to evaluate the impact of GSN's advanced preimplantation genetic diagnosis (PGD) with Parental Support™ on pregnancy and implantation rates in IVF. "IPSO", or - "Impact of Parental Support on pregnancy Outcomes", is a multicenter U.S. trial designed to evaluate the potential of GSN's PGD technology to increase in vitro fertilization (IVF) success. This study is the first multicenter trial to evaluate the efficacy of next generation microarray PGD.
“IVF Florida has a history of leading the field by bringing new technologies to patients and supporting medical research. This trial is a groundbreaking study that will have significant implications for patients and the field of reproductive medicine.”
The trial will evaluate testing of embryos both on Day 3 of development and on Day 5. Roll out of the Day 3 testing arm began in late September 2010. The Day 5 testing arm is expected to begin in January 2011. Initial IVF centers recruiting for the Day 3 arm include: IVF Florida, Fertility Specialists of Houston, Huntington Reproductive Center, Fertility Centers of Illinois, Shady Grove Fertility, Centers for Reproductive Medicine in Reno, and The Advanced IVF Institute in Chicago. Additional centers will be added as the study progresses.
Study subjects enrolled in the trial will be randomized to either a Test or Control arm. Subjects in the Test arm will have their embryos tested before transfer to the mother's uterus to determine whether they are likely to have a normal number of chromosomes. Embryos with an abnormal number of chromosomes, a condition called aneuploidy, tend to develop abnormally and either fail to become a pregnancy, result in miscarriage, or result in the birth a baby with birth defects. If successful, the trial will demonstrate that use of GSN's PGD technology during IVF will increase the chance that an embryo will implant and result in a healthy baby.
"PGD techniques and technologies have improved dramatically in the past few years, and we are seeing substantially better outcomes than were produced with old approaches," said Matthew Rabinowitz, PhD, Chief Executive Officer of Gene Security Network. "The field of reproductive medicine has for some time needed a multicenter prospective randomized trial to formally evaluate the impact of newer and more comprehensive testing technologies, like Parental Support, on pregnancy rates. We are pleased that Ferring Pharmaceuticals is collaborating with us to bring this study to fruition. We hope and expect that the promising results we have seen previously will be replicated in this controlled trial."
"We are excited to be the first IVF center open for recruitment," said David Hoffman, MD, Infertility Specialist and Lead Investigator at IVF Florida for the IPSO trial. "IVF Florida has a history of leading the field by bringing new technologies to patients and supporting medical research. This trial is a groundbreaking study that will have significant implications for patients and the field of reproductive medicine."
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