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Who Is Doing The Study?
Auxogyn, Inc. has selected Pacific Fertility Center as one of several centers to participate in The Auxogyn Eeva Study
Why Are We Doing This Study
Auxogyn is initiating a clinical study in an effort to submit data to the FDA to support the claim that the Eeva System may be used to identify embryos at day 2 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.
Who Is Eligible?
You are being asked to take part in this research study because you are undergoing IVF treatment. The key patient eligibility criteria¹ include:
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Women undergoing fresh IVF treatment using their own eggs or donor eggs.
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Total FSH under 10 and antral follicle count of at least 12 as measured prior to stimulation.
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No preimplantation genetic diagnosis or preimplantation genetic screening planned.
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Fertilization using only ejaculated sperm (fresh or frozen).
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No concurrent participation in another clinical study.
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Willing to provide written informed consent.
How Data Will Be Used
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 2 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 2 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 2 or day 3) and reduce multiple pregnancies. In summary, this new technology may increase IVF success rates within a given cycle and improve pregnancy and birth outcomes.
Questions?
If you are interested in learning more details about this study, please contact Pacific Fertility Center at 415-834-3095 or email us at research@pacificfertility.com
Please click here for additional information from ClinicalTrials.gov
1. Your IVF clinic can provide you with a complete list of patient eligibility criteria.
CAUTION: Investigational device. Limited by Federal (or United States) law to investigational use.
NO LONGER ENROLLING
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