Noninvasive genetic testing laboratory Natera Inc, San Carlos, Calif, has announced the publication of study results demonstrating that the company’s Spectrum preimplantation genetic screening test for aneuploidy (PGT-A) can improve in vitro fertilization (IVF) results for all women, including those of advanced maternal age.1 

The study retrospectively analyzed pregnancy outcomes from more than 1,800 IVF cycles performed at two fertility centers using Spectrum, a single-nucleotide polymorphism (SNP)-based PGT-A technology. Spectrum screens all 24 chromosomes to provide comprehensive embryo aneuploidy results. Aneuploidy, an abnormal number of chromosomes, is common in human embryos—particularly as women age—and is the primary cause of failed IVF.2

In the United States, less than half of all in vitro transferred embryos implant and lead to pregnancy.3,4 According to Natera, the recent study indicated that use of Spectrum PGT-A testing during IVF led to increased rates of implantation (70%), clinical pregnancy (71%), and live birth (65%). The rates were achieved primarily with single embryo transfer (SET), substantiating routine use of SET with SNP-based PGT-A. In addition, with the use of PGT-A, pregnancy implantation rates remained high even among older women, supporting the use of PGT-A to improve implantation rates in women of advanced maternal age.3,4

Martin

Kimberly Martin, MD, Natera.

“This study shows that Spectrum PGT-A can help mitigate the negative effects of maternal age on IVF outcomes by allowing selective transfer of embryos that are more likely to lead to sustained implantation,” says Kimberly Martin, MD, Natera’s senior global medical director for women’s health. “These findings also demonstrate that successful IVF can be achieved without multiple-embryo transfer when combined with PGT-A. Increased use of single embryo transfer should reduce the incidence of multiple pregnancies, which are associated with higher pregnancy complication rates, in addition to financial and psychosocial challenges for families.”

Spectrum’s patented SNP-based technology provides a comprehensive 24-chromosome PGT-A with an accuracy greater than 99% per chromosome call, helping provide the best chance of transferring an embryo with the correct number of chromosomes. Identifying the healthiest embryos for transfer improves the chance of a successful pregnancy while reducing the chance of miscarriage or of having a child with a chromosome condition. Spectrum is part of Natera’s portfolio of genetic diagnostic and screening tests designed to help families on the path to parenthood.

The Spectrum preimplantation genetic test was developed by Natera under terms of the Clinical Laboratory Improvement Amendments of 1988 (CLIA). FDA does not currently clear or approve laboratory-developed tests, but CLIA certification of the laboratory is required to ensure the quality and validity of such tests.

To learn more, visit Natera.

References

  1. Simon AL, Kiehl M, Fischer E, et al. Pregnancy outcomes from more than 1,800 in vitro fertilization cycles with the use of 24-chromosome single-nucleotide polymorphism-based preimplantation genetic testing for aneuploidy.Fertil Steril. 2018;110(1):113–121; doi: 10.1016/j.fertnstert.2018.03.026.
  1. Hodes-Wertz B, Grifo J, Ghadir S, et al. Idiopathic recurrent miscarriage is caused mostly by aneuploid embryos. Fertil Steril. 2012;98(3):675–680; doi: 10.1016/j.fertnstert.2012.05.1025.
  1. 2015 Assisted Reproductive Technology National Summary Report. Atlanta: Centers for Disease Control and Prevention, American Society for Reproductive Medicine, Society for Assisted Reproductive Technology, 2017. Available at: www.cdc.gov/art/pdf/2015-report/art-2015-national-summary-report.pdf.  Accessed September 16, 2018.
  1. Toner JP, Coddington CC, Doody K, et al. Society for Assisted Reproductive Technology and assisted reproductive technology in the United States: a 2016 update. Fertil Steril. 2016;106(3):541–546; doi: 10.1016/j.fertnstert.2016.05.026.