About Auxogyn

Auxogyn is a privately held medical technology company focused on advancing women’s reproductive health. The company is coupling its scientific and clinical expertise in early human developmental biology with unique analytical tools to advance the field of assisted reproduction.

For the past 30 years, researchers have been striving to identify the embryo(s) most likely to implant and result in a healthy live birth. Unfortunately, human reproduction is not an efficient process and only 15 percent of embryos transferred result in a pregnancy. To achieve high pregnancy rates, multiple embryos are transferred in each cycle to overcome the low implantation rate. As a result, the multiple pregnancy rate is 20 times higher than the spontaneous multiple pregnancy rate in the general population.

Twin pregnancies and high-order multiple pregnancies significantly compromise both maternal and perinatal health. In the late 1990s, improved culture media enabled blastocyst culture, allowing embryos to grow in a petri dish for two to three additional days and potentially improving the probability of success. Studies have shown that transferring embryos at the blastocyst stage more than doubles the chance of a live birth when compared to day three transfer for certain age groups.

However, culturing embryos for two extra days outside the body is challenging and has some adverse effects. As a result, many clinicians prefer to transfer the embryo back into the mother as soon as possible. Early prediction, at day two or day three, of an embryo’s ability to form a blastocyst may provide IVF patients with the same live birth success rate without the risk of extended culture.

The Auxogyn advantage

Auxogyn’s product, the Early Embryo Viability Assessment (Eeva™) System is based on research conducted at Stanford University and published in the highly regarded scientific journal “Nature Biotechnology” (October 2010). The technology systematically measured three distinct time periods in early human development and predicted on day two which embryos would continue development through day five (blastocyst stage) with a very high degree of accuracy.

Auxogyn is now commercially developing and validating the Eeva System to provide precision imaging of embryos at critical developmental time points and ensure accurate, consistent embryo assessments for embryologist prior to embryo transfer.

The Eeva System includes four proprietary components: a microscope, a petri dish, software, and system accessories (computer, display, cables, and stoppers). The Eeva microscope is small, lightweight, and fits inside a standard IVF incubator. A patient’s embryos will be placed in the Eeva Petri Dish, and the dish will be placed on the platform of the microscope. The Eeva System then takes very low-level illumination pictures of developing embryos every five minutes to help record and identify key events that take place during the first few days. The recorded images are stored on a computer and the Eeva Software measures three timing parameters and identifies those embryos on day two that are most likely to form blastocysts.

THE Auxogyn Eeva Study

Auxogyn is initiating a clinical study early in 2011 and the data will be submitted to the FDA to support the claim that the Eeva System may be used to identify embryos at day two that are most likely to form blastocysts. As a result, the Eeva System Study is an investigational study and is a non-significant risk device. Several fertility clinics have been evaluated and selected to participate in this study.

You are being asked to take part in this research study because you are undergoing IVF treatment. The key patient eligibility criteria include:

  • Women undergoing fresh IVF treatment using their own eggs or donor eggs.
  • Total antral follicle count of at least eight as measured prior to stimulation.
  • No preimplantation genetic diagnosis or preimplantation genetic screening planned.
  • Fertilization using only ejaculated sperm (fresh or frozen).
  • No concurrent participation in another clinical study.
  • Willing to provide written informed consent.

The data collected in this study are intended to demonstrate the effectiveness of the Eeva System to successfully capture and record images of embryo development within a standard incubator and accurately identify those embryos on day two that are most likely to form blastocysts. The results may lead to effective methods for embryologists to identify the most viable embryos so that embryo implantation and pregnancy outcome may be significantly improved for future IVF patients.

A higher success rate such as that seen with blastocyst transfer may be achieved for day two embryo transfer by using the Eeva System to select embryos; therefore, the adverse events associated with extended culture may be avoided. It may also facilitate implementation of single embryo transfer on cleavage stage (day two or day three) and reduce multiple pregnancies. In summary, this new technology may increase IVF success rates within a given cycle and improve pregnancy and birth outcomes.

If you are interested in learning more details about this study, please contact your IVF clinic.

Caution

Investigational device. Limited by Federal (or United States) law to investigational use.