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Unreliable PGT-A Tests Shouldn’t Make It Worse.

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PGT-A Lawsuit

Is PGT-A as Good as Advertised?

After years of being unable to have a baby by other means, you decide it is time to save your money, take on a second job, and/or borrow money so that you can try for a baby using in vitro fertilization (IVF). Your emotions are ping-ponging as you begin the process in hopes of having your miracle baby as soon as possible when you learn of an add-on to the IVF process called PGT-A, or preimplantation genetic testing for aneuploidy.

You are informed that PGT-A is highly efficient, as high as 98% accurate, in determining whether your embryos are genetically “normal” or “abnormal”. You also learn that PGT-A increases the chance of pregnancy, decreases the chance of miscarriage, and increases the success of IVF among other benefits. With promises like that, you decide that PGT-A is worth the additional money, even if your insurance company will not pay for it.

But is it?

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We’re changing the narrative about lawsuits.^™

“PGT-A tests have been prematurely incorporated into fertility medicine.”

– Josephine Johnston, bioethicist and director of research at Hastings Center.¹

What Is PGT-A Testing?

IVF is a process of fertilization in which an egg is combined with sperm in vitro (“in glass”) to create embryos. Once embryos reach the blastocyst stage, PGT-A testing is performed by extracting a few cells from the blastocyst’s trophectoderm and shipping these cells, called the biopsy, to a lab for testing. The biopsy is then analyzed by the lab to determine if the biopsy contains a normal or abnormal number of chromosomes.

Based upon its analysis of the biopsy, the lab represents whether the entire embryo, including the inner cell mass, is “euploid,” “mosaic” or “aneuploid.” “Euploid” embryos are considered “normal” and suitable for transfer, “aneuploid” embryos are considered “abnormal” and not suitable for transfer, and whether an embryo is “mosaic” differs by lab and may or may not be suitable for transfer.

The procedure: A small number of cells are taken from the outer cell, which ultimately becomes the placenta, to predict the genetic makeup of the entire embryo.

“Labs only test five cells from around 150 that make up the fertilized egg,” said Dr. Hugh Taylor, chairman of the Department of Obstetrics, Gynecology and Reproductive Sciences at the Yale School of Medicine. “We’re fooling ourselves if we think we have full information on an embryo based on those few cells.”¹

Are PGT-A Tests Reliable and Accurate?

Since preimplantation genetic testing was first introduced, its efficacy and usage in IVF has been called into question since as early as 2005. Researchers have repeatedly determined that preimplantation genetic testing has no benefit over standard IVF and that its benefits are unsupported by scientific evidence.²

In 2019, Santiago Munne and his fellow researchers found that PGT-A did not improve overall pregnancy outcomes, did not improve live birth rates, and did not reduce miscarriage rates.³ In 2020, a study found that PGT-A resulted in a lower chance of live birth in all age groups compared to transfer of embryos without PGT-A.⁴

In November 2021, the New England Journal of Medicine published the results of a randomized controlled trial in which they determined that conventional IVF treatment was noninferior to PGT-A and that “the results of trophectoderm biopsy may not totally represent the genetic composition of the inner cell mass of the blastocyst.” A similar finding occurred in 2023 when researchers determined that there is no clear improvement to cumulative live birth rates with PGT-A and there is a reduction in live birth rates among the youngest IVF patients.

In 2018 and then again in November 2023 and May 2024, the American Society for Reproductive Medicine (“ASRM”) and the Society for Assisted Reproductive Technology (“SART”) issued opinions stating that the “value of preimplantation genetic testing for aneuploidy (PGT-A) as a universal screening test for all patients undergoing in vitro fertilization (IVF) has not been established.”

Despite this scientific research as well as other studies, PGT-A continues to be marketed and sold as an add-on to IVF with significant benefits.

So Why Does PGT-A Testing Exist? (Hint: Money.)

Regardless of the scientific research showing the lack of efficacy and benefit to PGT-A testing, its use has spiked significantly in recent years due to marketing and advertising efforts. From 2014 to 2021, the use of PGT-A testing increased from being utilized in 13% of IVF cycles to approximately 40% of IVF cycles. Due to its increasing use, the PGT-A testing industry now generates an estimated revenue of between $300 million to $400 million dollars per year.

Due to its increasing use, the PGT-A testing industry now generates an estimated revenue of between $300 million to $400 million dollars per year.

“Some patients may have paid for this expensive treatment, and in doing so, may have reduced their chances of having a baby through IVF,” said Jack Wilkinson, a research fellow at the University of Manchester in the U.K. who analyzes reproductive medicine data.⁸

Can I File a Lawsuit for PGT-A Testing?

Yes. A lawsuit has been filed which alleges that:

PGT-A testing can and does result in the unnecessary loss of embryos.
PGT-A testing can and does result in embryos that could result in live births not being transferred.
PGT-A testing can and does result in embryos that could result in live births being discarded.
PGT-A testing can and does result in additional egg retrievals.
PGT-A testing can and does provide false positives and false negatives.
PGT-A testing can and does result in important decisions being made during IVF based upon inaccurate information.
PGT-A testing can and does result in embryos being unable to be transferred.
Inaccurate PGT-A testing can and does result in healthy babies being born from embryos deemed “abnormal” and “unsuitable for transfer”.

If you had PGT-A testing performed on your embryos, you have legal options.

Please reach out to learn more about current class action lawsuits as well as other lawsuits being prepared filed based upon the misleading marketing of PGT-A testing.

We Have Been Here for Women Since the Beginning.

A Case for Women was founded in 2017 by women, for women. Among our growing team of 75 team members across the country are women who have had all their children via IVF and not necessarily on the first try. We are women who’ve had miscarriages, healthy & unhealthy births. We’ve tried and pretty successfully juggled career, relationship, and children – a near impossible juggling act, if you ask us.

The PGT-A case is of particular importance to us. We are outraged by the culture of corporate greed leading to the misrepresentation of sensitive data that women have relied and depended upon in order to make the most informed decisions possible for their families.

If you’re going through IVF and confused about this scam, wow, please contact us 24/7/365 so we can help. There is strength in numbers and, you know, it takes a village. We might know something you’ve not been informed about or vice versa. If you’ve been affected by PGT-A testing, you may have legal grounds to sue.

Sources

Jacquelynn Kerubo, “After Genetic Testing, I Took a Chance on an ‘Imperfect’ Pregnancy,” New York Times, April 7, 2021.
Paulson, R. Hidden in plain sight: the overstated benefits and underestimated losses of potential implantations associated with advertised PGT-A success rates. Human Reproduction, Vol. 35, Issue 3, p. 490-493 (March 2020).
Munne, S., et al., Preimplantation genetic testing for aneuploidy versus morphology as selection criteria for single frozen-thawed embryo transfer in good-prognosis patients: a multicenter randomized clinical trial. Fertility and Sterility, Vol. 112, No. 6, December 2019.
Doody, K. Live Birth Rate Following PGT Results in Lower Live Birth Rate Compared to Untested Embryos Transferred at Day 5/6. Fertility and Sterility. Vol. 114, Issue 3, Supplement E419 (September 2020).
Kucherov, A. et al. PGT-A is associated with reduced cumulative live birth rate in first reported IVF stimulation cycles age ≤; an analysis of 133,494 autologous cycles reported by SART CORS, Journal of Assisted Reproduction and Genetics (2023) 40:137-149.
Practice Committee of the American Society for Reproductive Medicine and the Genetic Counseling Professional Group. Clinical management of mosaic results from preimplantation genetic testing for aneuploidy of blastocysts: a committee opinion. Fertility and Sterility. Vol. 120, No. 5. November 2023.
Isabella Cueto, New research casts fresh doubt on a common procedure that promises to increase the odds of IVF, STAT News, November 26, 2021.

WE WEAR THIS BADGE PROUDLY. Because, in a time when legal services are still dominated by men, only a Women Owned Business can bring the woman’s perspective to issues that disproportionately affect women.

We are the ones, far more than men, who are injured by sexual assault, financial scams, the gender pay gap, toxic chemicals, and the misguided practices of powerful pharmaceutical companies.