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Controlled Clinical Trial
Journal Article
Improved implantation rates of day 3 embryo transfers with the use of an automated time-lapse-enabled test to aid in embryo selection.
Fertility and Sterility 2016 Februrary
OBJECTIVE: To determine if an automated time-lapse test (TL-test) combined with traditional morphology for embryo selection and day 3 transfer results in improved clinical outcomes.
DESIGN: Prospective concurrent-controlled pilot study.
SETTING: IVF clinic and laboratory.
PATIENT(S): A total of 319 female patients <41 years old, with day 3 embryo transfer, fewer than three failed IVF cycles, and at least four zygotes (2-pronuclear) on day 1.
INTERVENTION(S): Automated time-lapse embryo assessment combined with morphologic assessment in the study (test) group compared with morphologic assessment only (control group).
MAIN OUTCOME MEASURE(S): Embryo implantation, pregnancy, and multiple pregnancy rates. Subanalysis of implantation potential of embryos based on the TL-test (TL-high vs. TL-low) scores.
RESULT(S): Implantation and clinical pregnancy rates were significantly higher in the test group compared with the control group (implantation rates 30.2% vs. 19.0%, clinical pregnancy rates 46.0% vs. 32.1%, respectively). Multiple pregnancy rates were not statistically different (26.7% vs. 18.3%). Test group patients receiving at least one TL-high embryo had significantly higher implantation rates than patients receiving only TL-low embryos (36.8% vs. 20.6%). TL-high compared with TL-low embryos had significantly higher implantation rates (44.7% vs. 20.5%). Among morphologically good embryos, TL-high embryos were more likely to implant than TL-low embryos (44.1% vs. 20.6%).
CONCLUSION(S): This is the first report demonstrating improved implantation rates in patients receiving day 3 embryo transfers based on the combined use of a TL-test along and traditional morphology. Our findings confirm that the noninvasive TL-test adds valuable information to traditional morphologic grading.
CLINICAL TRIAL REGISTRATION NUMBER: NCT01671657.
DESIGN: Prospective concurrent-controlled pilot study.
SETTING: IVF clinic and laboratory.
PATIENT(S): A total of 319 female patients <41 years old, with day 3 embryo transfer, fewer than three failed IVF cycles, and at least four zygotes (2-pronuclear) on day 1.
INTERVENTION(S): Automated time-lapse embryo assessment combined with morphologic assessment in the study (test) group compared with morphologic assessment only (control group).
MAIN OUTCOME MEASURE(S): Embryo implantation, pregnancy, and multiple pregnancy rates. Subanalysis of implantation potential of embryos based on the TL-test (TL-high vs. TL-low) scores.
RESULT(S): Implantation and clinical pregnancy rates were significantly higher in the test group compared with the control group (implantation rates 30.2% vs. 19.0%, clinical pregnancy rates 46.0% vs. 32.1%, respectively). Multiple pregnancy rates were not statistically different (26.7% vs. 18.3%). Test group patients receiving at least one TL-high embryo had significantly higher implantation rates than patients receiving only TL-low embryos (36.8% vs. 20.6%). TL-high compared with TL-low embryos had significantly higher implantation rates (44.7% vs. 20.5%). Among morphologically good embryos, TL-high embryos were more likely to implant than TL-low embryos (44.1% vs. 20.6%).
CONCLUSION(S): This is the first report demonstrating improved implantation rates in patients receiving day 3 embryo transfers based on the combined use of a TL-test along and traditional morphology. Our findings confirm that the noninvasive TL-test adds valuable information to traditional morphologic grading.
CLINICAL TRIAL REGISTRATION NUMBER: NCT01671657.
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