CAMBRIDGE, UK and LIVINGSTON, NJ--(Marketwire - June 07, 2012) - BlueGnome and Reprogenetics announce a randomised clinical trial (RCT) to investigate the benefits of 24 chromosome pre-implantation genetic screening (PGS) to patients undergoing IVF at 5 US infertility clinics (Boston IVF, MA; Long Island IVF, NY; Reproductive Associates of Illinois, IL; Main Line Fertility and Reproductive Medicine, PA; Georgia Reproductive specialists, GA).
With advancing maternal age, more embryos have major chromosome abnormalities, increasing from 60% in women younger than 35 to 80% in women 40 and older. Implanting a chromosomally abnormal embryo typically results in IVF failure, where an embryo fails to implant or there is a pregnancy loss (miscarriage). To reduce the chance of failure, IVF clinics often transfer multiple embryos during IVF to increase the probability that at least one is chromosomally normal. However, this comes at a cost. If two or more normal embryos implant, twins or triplets may result, which are at a higher risk of congenital abnormalities, premature birth, and developmental problems.
24sure is a new technology, developed by BlueGnome, which offers the possibility of pre-implantation genetic diagnosis of embryos to select a single, normal embryo for transfer. This study will assess whether single embryo transfer IVF with PGD delivers the same or superior pregnancy rates to multiple embryo transfer IVF without PGD.
Specifically, the RCT will compare a control group (standard of care), who will have up to 2 embryos implanted on day 5 based on developmental characteristics, with a test group who will have blastocysts biopsied on day 5, PGD performed with 24sure, and a single euploid embryo transferred on day 6. Recruited patients (110 in each arm) will be randomised on day 5.
Observational studies have indicated that the number of embryos that will implant will be higher in the PGD group and that the miscarriage rate will be reduced, however, suitable RCTs have not been performed. This RCT is therefore of significant importance to the field.
"We predict that the current IVF paradigm of replacing multiple embryos will change with this study. Every patient will be able to receive a single embryo transfer while maintaining a very high chance of pregnancy, irrespective of maternal age, provided that normal embryos are produced," said the principal investigator, Dr. Santiago Munne, of Reprogenetics.
Reprogenetics is a leader in the field and was the first laboratory to validate 24sure for use in PGD (Gutierrez-Mateo et al., 2011) showing a 98% concordance when embryos were reanalysed. Preliminary data from more than 2000 cycles analysed by Reprogenetics indicate an average implantation rate exceeding 50%. Reprogenetics data also showed that the negative effect of maternal age appears to disappear when a normal blastocyst is replaced, and that all normal blastocysts are very likely to implant regardless of mother's age. Furthermore, Yang et al (2012) recently published the first randomised prospective IVF study of pre-implantation chromosome analysis using 24sure demonstrating that selectively implanting euploid embryos significantly increases pregnancy rates in young patients.
The study has been approved by Western IRB (#20070251) and registered Clinical Trials.gov (#NCT01546350).
Dr. Daniel Kenigsber: "This trial promises to determine the full potential of IVF outcomes when constrained to purely euploid embryo transfers. Beyond this, we will have to look at technical, uterine and cytoplasmic factors to explain failures".
Dr Emre Seli (Associate Professor, Research Director, Department of Obstetrics, Gynecology, and Reproductive Sciences, Yale University School of Medicine) says, "This multicenter randomized clinical trial involves leading centers in the United States and will help us determine the benefit of using 24 chromosome pre-implantation genetic screening (PGS) in women undergoing IVF with single embryo transfer. The results of this study will guide us in counseling our patients and selecting those that may benefit from this novel test".
Dr. Glassner, the Division Head of Infertility Main Line Health System and Clinical Professor Drexel School of Medicine says, "This trial may be considered a landmark study -- perhaps one of the most important in recent history. Not only will it demonstrate a remarkable improvement in pregnancy rates, but it will give us a vital insight and understanding of what has been such a frustrating enigma regarding implantation. But most importantly this study may help to ease the pain and suffering of thousands of infertility patients and replace that pain with the joy of parenthood".
Mark Perloe MD, Medical Director Georgia Reproductive Specialists: "The physicians and staff at GRS are excited to participate in the evaluation of CGH as a tool to both improve pregnancy rates and reduce the risk of multiple births. The ability to choose embryos with the highest fertility potential while reducing the risk of multiple births could be a major step forward in assisted reproductive technology care".
Nick Haan, CEO of BlueGnome Ltd commented, "We are very pleased to be working with a thought leader like Reprogenetics on a study which has the potential to drive forward the entire IVF field. We believe 24 chromosome PGD has the potential to become the default standard of care for all IVF procedures globally, and this study will provide key clinical evidence".