4.7 Article

A multicenter, prospective, blinded, nonselection study evaluating the predictive value of an aneuploid diagnosis using a targeted next-generation sequencing-based preimplantation genetic testing for aneuploidy assay and impact of biopsy

Journal

FERTILITY AND STERILITY
Volume 115, Issue 3, Pages 627-637

Publisher

ELSEVIER SCIENCE INC
DOI: 10.1016/j.fertnstert.2020.07.052

Keywords

Preimplantation genetic testing for aneuploidy (PGT-A); impact of biopsy; predictive value; aneuploid diagnosis; nonselection study

Funding

  1. IVI America
  2. Foundation for Embryonic Competence

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The study aimed to determine the predictive value of PGT-A testing in forecasting the failure of successful delivery, finding high accuracy in predicting delivery failure with aneuploid results. Additionally, trophectoderm biopsy did not have a detectable adverse impact on sustained implantation.
Objective: To determine the predictive value of an aneuploid diagnosis with a targeted next-generation sequencing-based preimplantation genetic testing for aneuploidy (PGT-A) assay in prognosticating the failure of a successful delivery. Design: Prospective, blinded, multicenter, nonselection study. All usable blastocysts were biopsied, and the single best morphologic blastocyst was transferred before genetic analysis. Preimplantation genetic testing for aneuploidy was performed after clinical outcome was determined. Clinical outcomes were compared to PGT-A results to calculate the predictive value of a PGT-A aneuploid diagnosis. Setting: Fertility centers. Patient(s): Couples undergoing their first in vitro fertilization cycle without recurrent pregnancy loss, antral follicle count < 8, or body mass index >= 35 kg/m(2). Intervention(s): None. Main Outcome Measure(s): The primary outcome was the ability of the analytical result of aneuploid to predict failure to deliver (clinical result). A secondary outcome was the impact of the trophectoderm biopsy on sustained implantation. Result(s): Four hundred two patients underwent 484 single, frozen, blastocyst transfers. The PGT-A aneuploid diagnosis clinical error rate was 0%. There was no difference in sustained implantation between the study group and an age-matched control group, where biopsy was not performed (47.9% vs. 45.8). Conclusion(s): The PGT-A assay evaluated was highly prognostic of failure to deliver when an aneuploid result was obtained. Additionally, the trophectoderm biopsy had no detectable adverse impact on sustained implantation. ((C) 2020 by American Society for Reproductive Medicine.)

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