Infertility Clinical Trial
Official title:
KIDScore D3 Clinical Study
The aim of this study is to demonstrate that the KIDScore D3 may be used to identify those embryos on Day 3 that are most likely to form blastocysts.
The safety and effectiveness of the KIDScore D3 was investigated in a prospective study. The
study was performed as a single arm, multicenter clinical study conducted at six sites in the
United States. This was a non-interventional clinical study where the KIDScore D3 was not
used during patient treatment. Briefly, the purpose of the study was to collect data to
evaluate the safety and effectiveness of the KIDScore D3's ability to predict which embryos
are most likely to develop to blastocyst stage. This was evaluated by using the KIDScore D3
as adjunct information to traditional morphological grading. Imaging data was collected on
embryos cultured to day 5. Embryologists were masked to imaging data and evaluation was only
based on morphology and KIDScore D3 scores.
This study aims at analyzing the utilization of established morphology methods with adjunct
outcome of an algorithm (KIDScore D3) that provides a score (1 - 5) from timings of
morphokinetic events.
A double-blinded, multi-center study, designed to evaluate the odds ratios and other measures
for outcomes of methodologies used for embryo assessment: day 3 morphology alone and day 3
morphology with KIDScore D3 results as adjunct information.
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