Large Prospective Randomized Trial Confirms Clinical Benefit of EmbryoScope® Time-Lapse System

The success rate of assisted reproduction was significantly increased by the use of revolutionary time-lapse technology

AARHUS, Denmark, Sept. 15, 2014 /CNW/ - A study accepted for publication in the renowned scientific journal Fertility & Sterility, confirms that a revolutionary and clinically certified technology can substantially increase the success rate in assisted reproduction.

     (Logo: http://photos.prnewswire.com/prnh/20130704/626274 )

     (Photo: http://photos.prnewswire.com/prnh/20140915/705975 )

The use of the EmbryoScope® time-lapse system significantly increased ongoing pregnancy rates, implantation rates as well as significantly reduced early pregnancy loss. These are results from one of the world's largest multi-center fertility clinics, IVI, based in Valencia Spain. The current study was conducted as a follow-up to a large retrospective analysis, which reported in 2012 that the combination of undisturbed culture and a customized embryo classification algorithm gave higher pregnancy rates. The data presented now confirm a relative improvement of more than 20 percent in clinical pregnancy rates by using the EmbryoScope® time-lapse system compared to standard evaluation procedures.

In the current study, 843 patients were randomized between treatment in the EmbryoScope® time-lapse system and standard incubation. Embryo evaluation in the time-lapse system made use of a customized morphokinetic model applying morphology and time-lapse variables to select embryos, whereas standard morphology was used in the standard incubation system. Patients receiving EmbryoScope® treatment using a morphokinetic model were 23.2% more likely to have an ongoing pregnancy as well as 35.7% less likely to experience an early pregnancy loss. Dr. Marcos Meseguer and his team have made this algorithm, which is available in IVI laboratories.  

"This is the largest trial to date to study the clinical benefits of time-lapse technology on clinical outcomes, and we are delighted to confirm our previous findings," says Dr. Meseguer, who conducted the survey. "IVI has always been at the forefront of offering our patients new and better treatments, and we were one of the first clinics in the world to offer the EmbryoScope® time-lapse system routinely to our patients. This also confirms that the research we have conducted in developing a customized embryo evaluation model will improve our efforts to help childless couples achieve the dream of parenthood."

The results reflect the benefit of using a customized evaluation model, which was developed by analyzing outcome results from previous treatments and combining this with the superior incubation in the EmbryoScope® time-lapse system. A previous study conducted by IVI indicates that improved incubation alone could not account for the large improvement in clinical outcomes observed in this study.  

"Unisense FertiliTech recognized the need to create advanced software to allow clinics to design and use models customized to their own clinical practice," says CSO Niels Birger Ramsing. "We continue to invest resources to improve these software tools and to develop start-up embryo evaluation models which can be readily used by a wider range of clinics."

The EmbryoScope® time-lapse system has been in clinical use since 2009 and has since been used for more than 200,000 patient treatments in 46 countries.

CEO Michael Reeslev says: "These results confirm outcome improvements reported from a number of clinics using our system and we are delighted that the prospective randomized controlled trial shows that our technology offers significant benefits to clinics and their patients."

About Unisense FertiliTech A/S: 

Unisense FertiliTech A/S was founded in 2003 to develop technology to improve human embryo assessment in assisted reproduction. Unisense FertiliTech has developed and manufactures the EmbryoScope® time- lapse system, facilitating improved IVF treatment, flexible work routines and effective communication through comprehensive documentation of embryo development and evolving improvements in selection. The system is FDA 510(k) cleared and CE marked as a Class II medical device.  

Our mission is: Through extensive research and clinical documentation, we provide fertility clinics with innovative technologies that increase the chances of positive pregnancy outcomes. "Your Success starts here" 

SOURCE: Unisense FertiliTech A/S

For further information: Tine Qvistgaard Kajhøj, Scientific Communication Coordinator, E-mail: tqk@fertilitech.com, Phone: (+45)8944-9500

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