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

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Authors:

Ashley W. Tiegs, M.D.. Xin Tao, Ph.D., Yiping Zhan, Ph.D., Christine Whitehead, R.N., Julia Kim, M.D., Brent Hanson, M.D., Emily Osman, M.D., Thomas J. Kim, M.D., George Patounakis, M.D., Ph.D., Jacqueline Gutmann, M.D., Arthur Castelbaum, M.D., Emre Seli, M.D., Chaim Jalas, Richard T. Scott Jr., M.D.

Abstract:

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/m2.


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.


Clinical Trial Registration Numbers

NCT02032264 and NCT03604107.

Fertility and Sterility

Editorial Office, American Society for Reproductive Medicine

Fertility and Sterility® is an international journal for obstetricians, gynecologists, reproductive endocrinologists, urologists, basic scientists and others who treat and investigate problems of infertility and human reproductive disorders. The journal publishes juried original scientific articles in clinical and laboratory research relevant to reproductive endocrinology, urology, andrology, physiology, immunology, genetics, contraception, and menopause. Fertility and Sterility® encourages and supports meaningful basic and clinical research, and facilitates and promotes excellence in professional education, in the field of reproductive medicine.

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