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Advanced Genetic Testing Technology Drives Progress in Reproductive Medicine: Study Results

Nov 16, 2020
By
CooperSurgical

A recent study demonstrated a significant increase in pregnancy and live birth rates associated with the use of artificial intelligence-assisted genetic testing technology alongside in vitro fertilization (IVF).

The challenges of infertility are notably widespread, impacting an estimated 48.5 million couples – approximately 15 percent of couples – worldwide. For many facing infertility struggles, the medical advances of assisted reproductive technology (ART) have made the possibility of having a baby a reality; today, it is estimated that 1.7 percent of all infants born in the United States every year are conceived using ART. Since its inception, IVF has become the most common type of ART – approximately 80,000 babies were born with IVF in the US in 2017.

Despite the tremendous progress that has been made with IVF to help address infertility, challenges have persisted. While live birth rates per cycle of IVF in the US steadily improved for years, in the last two decades there have been bouts of plateaus and declines – including a steady decline since 2010 – and this trend has also been observed internationally.

Efforts to continue improving embryo evaluation to determine viability, increase live births, improve pregnancy outcomes, and reduce multiples in pregnancy through single embryo transfer include the refinement of preimplantation genetic testing (PGT). PGT for aneuploidy (PGT-A) is performed on embryos produced through IVF to provide genetic information to help identify embryos that are more likely to result in a successful pregnancy.

CooperSurgical has contributed to advancements in PGT-A through its PGTaiSM technology, an advanced algorithm that harnesses the power of big data, machine learning, and artificial intelligence to maximize PGT-A analysis, interpretation, and reporting. The company’s PGTai 2.0 technology offers a further improvement with paired-end sequencing and single nucleotide polymorphism (SNP) analysis as a means of optimizing PGT-A analysis.

The PGTai 2.0 technology uses algorithms developed from real-world data to achieve an objective embryo assessment – eliminating the subjective interpretation of PGT results and reducing human error with transcription. Such innovation could help improve success rates for patients by objectively screening embryos – in turn bringing more patients one step closer to a successful pregnancy.

Recently, an independent, single-center study examined the impact of and outcomes associated with PGTai 2.0 technology utilization when screening embryos for IVF. The study, “Second Generation Artificial Intelligence Technology for Preimplantation Genetic Testing Improves Pregnancy Outcomes in Single Thawed Euploid Embryo Transfer Cycles (STEET)” was conducted by the New York University Langone Fertility Center (NYULFC), part of The Prelude Network.

These independent study results demonstrated a greater than 13 percent relative increase in ongoing pregnancy and live birth rates associated with the use of CooperSurgical’s PGTai 2.0 technology to screen embryos for IVF. Findings were presented at the American Society of Reproductive Medicine Virtual Scientific Congress by study investigators in October 2020.

About the Study

The retrospective cohort study evaluated whether the use of the PGTai technology improves discrimination between euploid, aneuploid, and mosaic embryos, and whether the use of PGTai technology improves IVF clinical outcomes.

The study included data from more than 700 patients at NYULFC and compared results from three next-generation sequencing (NGS) genetic tests: Standard NGS, NGS with first-generation artificial intelligence (PGTai 1.0 Technology), and NGS with second-generation artificial intelligence (PGTai 2.0 Technology).

Outcomes included rates of implantation, clinical pregnancy, biochemical pregnancy, spontaneous abortion, and ongoing pregnancy and/or live birth – defining the latter as pregnancies greater than 20 weeks over the total number of single thawed euploid embryos transferred (STEETs).

Improving IVF Outcomes with PGTai 2.0

Study investigators concluded that the PGTai 2.0 technology overall increased euploid reporting – and decreased aneuploid, simple mosaic, and complex mosaic reporting. Improvements were observed across key patient outcomes with the PGTai 2.0 technology compared to prior NGS technology – including increases in ongoing pregnancy and live birth rates, implantation rates, and clinical pregnancy rates for embryos diagnosed as euploid via PGTai 2.0.

Further, in this study, rates of unfavorable obstetric outcomes – specifically biochemical pregnancy loss and spontaneous abortions – were reduced through the PGTai 2.0 technology compared to assessments using NGS. However, the study was limited in size and not all data reached statistical significance.

Positive obstetric outcomes observed in this study:

 

NGS Subjective/Prior Methods

PGTai 2.0 Technology

Ongoing pregnancy and/or live birth*

62% (328/529)

70.3% (128/182)

Implantation Rate

78.4% (415/529)

82.9% (151/182)

Clinical Pregnancy Rates

71.6% (379/529)

77.4% (141/182)

 Adverse obstetric outcomes observed in this study:

 

NGS Subjective/Prior Methods

PGTai 2.0 Technology

Biochemical Pregnancy Loss birth*

8.6% (36/416)

4.63% (7/151)

Spontaneous Abortion Rates

12.4% (47/329)

11.3% (16/141)

*p<0.05

Implications for Reproductive Health Progress

The goal of PGT-A is to maximize the chances of IVF success by screening for embryos with the greatest potential for successful pregnancy. Data from this study demonstrate that PGTai 2.0 technology increases ongoing pregnancy and live birth rates, as compared with previous technologies.

"These findings are meaningful for the broader reproductive health community and support our collective mission to advance reproductive medicine and help families experiencing infertility," said Mike Large, PhD, study author and Senior Director of Genomics Research & Development at CooperSurgical. "Leveraging this cutting-edge technology allows us to advance diagnostic precision to contribute to more desirable pregnancy outcomes"

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