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RESULTS OF PIONEERING NEW IVF PROCESS PRESENTED
AT AMERICAN SOCIETY FOR REPRODUCTIVE MEDICINE 68TH ANNUAL MEETING

Single Embryo Transfer Using New Screening Technology Achieves Same Pregnancy Rates as Traditional Double Embryo Transfer

SAN DIEGO, CA– October 24, 2012 – Reproductive Medicine Associates of New Jersey (http://www.rmanj.com) today presented interim findings from its BEST (Blastocyst Euploid Selective Transfer) trial, the first well-controlled clinical trial comparing in vitro fertilization (IVF) pregnancy rates in a group of women receiving a single embryo transfer (SET) with comprehensive chromosome screening (CCS) with a group receiving traditional morphology-based double embryo transfer (DET). The findings were presented at the American Society for Reproductive Medicine 68th Annual Meeting in San Diego, October 20-24, 2012.

The study showed that using CCS and SET together provides ongoing pregnancy rates equivalent to traditional double embryo transfer while eliminating multiple gestation.

“This is the first time that a single embryo transfer trial has shown equal, and in fact better, outcomes than a traditional morphology-based double embryo transfer,” said Eric J. Forman, M.D., and lead investigator. “Advances in screening technology that allow us to rapidly and safely determine if an embryo is chromosomally normal now make SET a more viable pathway to pregnancy for couples undergoing IVF, while reducing the risk of complicated and costly multiple gestations. With accuracy rates up to 97%, our CCS technology platform helps make the promise of one embryo one healthy baby a reality.”

Assisted Reproduction Technology (ART) treatment, such as IVF, is the primary driver in the increase in twins and triplets over the last 25 years. Many fertility doctors routinely transfer more than one embryo, increasing the chances that at least one will result in a successful pregnancy – but also raising the odds of a multiple pregnancy. SET has been advocated to eliminate multiple gestation, but previous studies have demonstrated inferior delivery rates due to a limited ability to predict a given embryo’s reproductive potential.

Added Richard T. Scott, Jr., M.D., F.A.C.O.G., H.C.L.D., founding partner of RMANJ, “The most common and costly complication of IVF is multiple pregnancies and births. The BEST strategy shows that we can eliminate the complications associated with ART, while simultaneously improving delivery rates, reducing time-in-treatment for patients, and reducing overall costs. It is really a home run in every area.”

The Blastocyst Euploid Selective Transfer (BEST) Trial
The randomized controlled trial was designed to determine if CCS-SET can attain equivalent outcomes to morphology-based DET while minimizing multiple gestation. The study included patients <43 years old with AMH greater than or equal to 1.2 and a normal endometrium. They were randomized to quantitative PCR-based CCS-SET or morphology-based DET. If blastulation occurred by late afternoon on day 5, fresh embryo transfer was performed on day 6; otherwise, blastocysts were vitrified and transferred the next cycle.

At a planned interim analysis after the first 100 embryo transfers, the ongoing pregnancy rate was equivalent (CCS-SET=69%, DET=67%, p=.9). In contrast, the multiple gestation rate differed significantly (CCS-SET=0%, DET=58%, p=0.01). Among patients greater than or equal to age 35, the ongoing pregnancy rate was 68% for the CCS-SET group and 50% for the DET group. At the meeting, final study data on 170 randomized patients was presented and showed consistent results.

The BEST strategy was effective across age groups – even in patients of advanced age who are not typically considered for SET – and represents an opportunity to maintain high delivery rates while dramatically reducing the burden of treatment to patients, society, and ultimately the children conceived.

Single Embryo Transfer Background
The economic costs associated with multiple births from in vitro fertilization (IVF) are substantial and include both the immediate costs of maternal hospitalization and neonatal intensive care and the potential lifetime costs of care for chronic illness, rehabilitation and special education. Multiple pregnancy and birth also result in increased health risks for mothers.

In 2004, approximately 4% of all preterm births in the United States resulted from ART, with associated costs reaching $1 Billion.1

Single embryo transfer (SET) after IVF has been advocated as the only effective way to avoid multiple pregnancy in IVF cycles. However, the U.S. lags the rest of the world in establishing SET as its standard approach in IVF. This is further compounded by the fact that success rates in SET have traditionally been significantly lower based on a limited ability to predict an embryo’s reproductive potential.

In the United States, SET rates among patients under age 35 have increased 1-2% annually since 2002, accounting for approximately 10% of all transfers in this age group in 2009.1 These trends have resulted in an increase in double embryo transfers leading to a decrease in triplet gestation, but an unchanged rate for twin gestation.

According to the American Society for Reproductive Medicine, the barriers to increased use of SET include provider and patient education, financial considerations, effective embryo selection and successful cryopreservation.

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) to more accurately detect healthy embryos that will lead to successful pregnancies and ultimately healthy babies. Other centers have attempted similar testing methods, but RMANJ is the only fertility center in the world to have developed a system of unprecedented accuracy, fully 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 and pregnancy.

The fertility experts at RMANJ have among the highest IVF success rates in the country. Since 1999, they have helped bring more than 20,000 babies to loving families. In addition to serving as the Division of Reproductive Endocrinology at 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 www.rmanj.com.



1 American Society for Reproductive Medicine. Elective Single-Embryo Transfer. Fertil Steril 2012; 97: 835-842.