IVF Patients Say a Test Caused Them to Discard Embryos. Now They’re Suing

After struggling for eight years to have a baby, Shannon Petersen and her husband decided to try in vitro fertilization (IVF) in 2022. Their fertility doctor recommended a test that sounded like exactly what they needed. It promised to help Petersen, then 42, avoid miscarriages and get pregnant faster by determining which of the couple’s embryos were most likely to result in a healthy baby. The testing cost thousands of dollars and wasn’t covered by insurance, but it was advertised as close to 100% accurate and strongly recommended for women of Petersen’s age. “I said, ‘Yeah, that sounds amazing,’” she says. “Who wouldn’t?”

Her mood changed when the results came back. The test deemed each of the Petersens’ five embryos abnormal, meaning their clinic—like many in the industry—refused to use any of them. “It was like, ‘Well, better luck next time. These are garbage, essentially,’” Petersen says. “It was heartbreaking.”

The Petersens took out a $15,000 loan to try again. Their second IVF cycle yielded only one embryo, which they decided not to test; it did not result in a pregnancy. That disappointment felt like the end of the road. The couple began looking into fostering and adoption—until Petersen started researching the add-on test she’d taken the first time around: preimplantation genetic testing for aneuploidy (PGT-A). By some estimates, preimplantation testing is used in close to half of IVF cycles in the U.S.

PGT-A is a screening test performed after a patient’s eggs have been retrieved and fertilized to create embryos, but before any of those embryos have been transferred to her uterus. Clinicians take tiny biopsies from the embryos, removing just a few cells to check whether they have the right number of chromosomes. Embryos with cells that have either too many or too few chromosomes are less likely to result in full-term pregnancies, so PGT-A aims to identify them so clinicians can work with the strongest of the bunch.

But the more Petersen read, the more she doubted the test’s benefits. Numerous researchers, she learned, had questioned PGT-A’s accuracy, efficacy, and clinical usefulness. According to the American Society for Reproductive Medicine (ASRM) and the Society for Assisted Reproductive Technology, the value of the test “has not been demonstrated” for routine screening of all IVF patients.

Petersen soon found that scientists at the Stanford University School of Medicine were running a clinical trial to find out how often so-called abnormal embryos result in healthy babies. “No test is perfect,” says Dr. Ruth Lathi, a professor of obstetrics and gynecology at Stanford and one of the lead investigators of that trial. “Our curiosity was really driven by patient requests and patient questions, and a few isolated case reports of patients having successful pregnancies [using] reportedly abnormal embryos.” Research is ongoing, but Lathi hopes to track 200 women with abnormal embryos.

Newly disillusioned with PGT-A, the Petersens, who live in Northern California, enrolled in Lathi’s trial in 2024 as “a last ditch effort.” A doctor affiliated with Stanford began transferring their old embryos. Their first attempt didn’t take. But, in a shock even to her doctors, Petersen got pregnant on her second transfer—using an embryo that PGT-A had flagged as having a serious chromosomal abnormality.

She had a baby boy in November. Her son has not gone through additional genetic testing, but so far seems healthy and is hitting his developmental milestones. “I would not have a baby if I had believed the PGT-A test,” Petersen says.

How could an embryo that was never supposed to have a fighting chance become someone’s beloved son? That’s what the Petersens and nearly 700 other IVF users, along with plenty of doctors and scientists, would like to know. These patients have banded together to file class-action lawsuits against multiple U.S. providers of PGT-A testing—CooperSurgical, Natera, Reproductive Genetic Innovations (RGI), Ovation Fertility, Progenesis, and Igenomix—with lawyers promising that suits against additional testing companies are coming soon. Their legal complaints argue that patients were misled about the accuracy and utility of PGT-A, cheating them out of time, money, and even dreams of having families, since some people have discarded embryos based on the test results.

CooperSurgical, Natera, RGI, and Ovation Fertility have filed motions to dismiss the complaints against them, and Progenesis filed a motion for judgment on the pleadings, which seeks resolution of a complaint before trial. All of the cases were proceeding as of press time.

“PGT-A is an important screening test for IVF doctors and patients,” a spokesperson for Natera said in a statement to TIME. “Doctors determine which patients will benefit from PGT-A and, together with those patients, how it should be used. We stand by the statements we’ve made about our test, including its accuracy, and the benefits PGT-A can bring to patients as shown in published, peer-reviewed studies. The litigation against Natera is baseless.”

Representatives from RGI and Ovation declined to comment, citing ongoing litigation. CooperSurgical and Progenesis did not respond to multiple requests for comment. A representative for Igenomix’s parent company referred TIME to a press release, which says its legal counsel is reviewing the case.

Allison Freeman, whose Florida-based firm Constable Law is spearheading the class-action suits, is an IVF mother herself. She became “obsessed” with PGT-A after clinicians made her feel “crazy” for opting out when she was a patient, and only more so after two of her friends ended up with no usable embryos after going through PGT-A testing. Curious, Freeman dug into online fertility communities, where numerous women reported upsetting experiences related to PGT-A: cycles of failed tests, inconsistent results, and even unlikely births like Petersen’s.

Freeman was left with questions not only about this particular test, but also about the entire IVF industry. “It’s the Wild West of medicine,” she says. “What if this is the tip of the iceberg?”

In the U.S., oversight of the IVF industry is dictated by a combination of state and federal policies and “self-regulation” by professional societies like ASRM (which did not make any of its spokespeople available for interviews for this story). Under this patchwork system, adoption of a new technology sometimes outpaces research and regulation around it, often driven by commercial interests, says Rosario Isasi, a lawyer and associate professor of human genetics at the University of Miami Miller School of Medicine who researches the ethics of genomics.

PGT-A “started as an experimental procedure and then it moved to be considered standard practice,” Isasi says. “Now, with the passage of time and more studies looking at the efficacy and safety,” some experts are debating whether that’s a good thing, especially since there’s minimal regulation dictating how companies develop, offer, and market these tests.

Although labs that perform PGT-A testing and medical devices used in IVF are subject to oversight by federal health agencies, the U.S. Food and Drug Administration has not authorized any add-on preimplantation genetic tests. States could craft their own regulations around IVF-related testing, but lawmakers have largely left the issue alone. One 2020 study co-authored by Isasi, which compared preimplantation testing regulations in 19 countries, concluded that the U.S. and Mexico have the most hands-off policies in the bunch.

Some see the proliferation of add-on services as a cash grab, since tests like PGT-A are rarely covered by insurance and can cost thousands of dollars out of pocket. But proponents say they help introduce some order to the chaos of human reproduction.

Just like those who try to conceive the old-fashioned way, couples who use IVF get no guarantees. Despite the advanced science behind the procedure—and the astronomical price tags charged for it—IVF cycles often fail. PGT-A was pitched as a way to remove some of the guesswork.

Instead of using more rudimentary methods to assess embryo quality—or transferring multiple at once to increase the chances that at least one would take—PGT-A guides clinicians toward embryos that are most likely to result in full-term, healthy pregnancies. Doctors cross their fingers for “euploid” embryos (whose cells have the right number of chromosomes) and hope to avoid “aneuploid” embryos (whose cells don’t). Between those black-and-white results, there’s a whole world of gray: “mosaic” embryos that have a mix of normal and abnormal cells, “segmental” errors that affect only pieces of chromosomes, and more. How much specificity a patient receives depends, in part, on the clinic they visit and the lab that clinic uses, says Dr. Vasiliki Moragianni, medical director of the Johns Hopkins Fertility Center.

Unlike other prenatal tests, PGT-A is not explicitly meant to diagnose fetal health problems, although it can pick up on signs of chromosomal disorders such as Down syndrome. At its core, it’s a ranking tool, says Darren Griffin, a professor of genetics at the University of Kent in the U.K., whose research contributed to the development of the technology.

Consider a patient who has five embryos after an IVF cycle. Without PGT-A, her doctor can make educated guesses about which one is best. Maybe they’ll get lucky on the first try, or maybe it will take five separate transfers to find the one with the best shot of success—assuming, of course, she has the time, patience, and money to make it that far.

If she uses PGT-A, on the other hand, her doctor could identify the best embryo from the jump, ideally allowing her to avoid the hassle and heartache of four failed transfers or miscarriages, Griffin says. On paper, the end result is the same—a live birth—but the process is far smoother thanks to PGT-A. That’s especially beneficial, Griffin says, for patients likely to struggle to conceive even with the assistance of IVF, such as older women and those with previous pregnancy losses. “If you are in a higher risk group,” he says, “it’s certainly worth considering.”

Lots of other doctors vouch for PGT-A too, as evidenced by the fact that it’s so widely used. And plenty of studies suggest that it can fulfill its promises, namely by helping patients endure fewer embryo transfers and miscarriages on the path to parenthood.

Dr. James Grifo, director of the NYU Langone Fertility Center and a pioneer of genetic testing in fertility care, says PGT-A is popular in his practice—about 90% of patients opt in after receiving information about the test—and has greatly improved outcomes. “Yesterday, I did 11 pregnancy scans,” and all were healthy, he says. Back in the 1990s, before modern practices like widespread PGT-A testing, “if I had 11 pregnancies, I’d be telling four patients, ‘I’m so sorry, your pregnancy has a problem.’”

PGT-A’s benefits are “so obvious,” he says. “It’s hard to believe it’s not more obvious to most.”

And yet, the chorus of PGT-A skeptics is getting louder. Within that group, there’s arguably no one so vocal as Dr. Norbert Gleicher, an infertility specialist and medical director of the Center for Human Reproduction in New York City. Gleicher has asserted that IVF birth rates have fallen as add-ons like PGT-A become more popular—in other words, he claims that the test is making IVF worse rather than better. “PGT-A is actually harmful to a lot of patients,” Gleicher says. “It’s kind of shameful. There are not many things in medicine that are getting worse, and at the same time getting more expensive.”

Gleicher’s argument boils down to this: PGT-A too often brands embryos abnormal, and thus unusable, when they actually aren’t. That raises a horrible prospect: are people needlessly throwing away embryos that could become their children?

More than a decade ago, emboldened by studies questioning the efficacy of PGT-A, Gleicher began transferring abnormal embryos to consenting patients who had no euploid embryos left to work with. Often, these experiments never resulted in pregnancy or ended in loss. But sometimes, as he has since reported in multiple studies, “we started seeing healthy, chromosomally normal pregnancies.”

Researchers like Lathi, from Stanford, are doing more research to determine whether such results are “one in a million, one in a thousand, one in a hundred, or one in 10,” she says. But how could they happen at all?

Gleicher believes that even embryos PGT-A calls aneuploid sometimes have reproductive potential. In his view, biopsies of just a few cells—which are taken from the part of an embryo that goes on to become the placenta, not the fetus itself—are “totally insufficient” to make potentially life-altering decisions. (Some researchers even fear biopsies themselves may damage an embryo; the ASRM says there “are few data on embryo biopsy techniques used in PGT-A.”) And he’s not alone in that view. “Is testing cells from the outside layer of the embryo representative of the chromosomal makeup of the embryo proper?” asks Moragianni. “It’s possible that it’s not.”

Although few go as far as Gleicher, experts widely recognize that embryo quality is more of a spectrum than a binary. “Every embryo has abnormal cells in it,” Grifo says. As long as they’re rare, they’re likely inconsequential. If at least 80% of biopsied cells are normal, most testing platforms will return a “euploid” result.

Even higher levels of abnormality don’t always make for serious problems. Studies suggest that mosaicism is common in embryos, and that even those with multiple chromosomal abnormalities can result in healthy, full-term pregnancies—albeit less often than euploid embryos. In these lucky cases, natural biological processes seem to allow the normal cells to overtake the abnormal ones. “If the normal cells take over, you get a baby,” Grifo says. “If the abnormal cells take over, it doesn’t make a pregnancy, usually, or it makes for a higher chance of a miscarriage.” Gleicher’s research also suggests abnormal cells sometimes self-correct in the womb.

Read More: How to Negotiate Your Medical Bills

Grifo says his clinic never discards embryos that fit into this gray area and employs genetic counselors trained to inform patients about their risks and benefits. Most often, he says, patients opt not to use embryos with lower odds of success.

As long as patients get enough accurate information to go into testing with eyes open, Isasi says, there’s no problem with clinicians offering it. The cornerstone of medical ethics “is informed consent—the ability of the patient to weigh the risks and potential benefits,” she says.

But not all clinics give patients so much agency. After two IVF cycles and $30,000 spent, Alexandra Zuk, a 39-year-old in South Carolina, and her husband were “devastated” to have no embryos their clinic considered good enough to transfer. They were willing to take their chances with those they had, Zuk says, but weren’t allowed. They thought about switching to a more flexible clinic but never found one to work with. “We don’t even know that I can carry a pregnancy because I never had the option to even try,” she says.

Eventually, rather than pay storage fees for embryos they were told they couldn’t use, the couple discarded them last year. “We felt like we hit a dead end,” she says. Now, Zuk, who is one of Freeman’s clients, is haunted by what-ifs. Were those embryos really nonviable? Wasn’t it worth a try?

Most researchers believe that if embryos are aneuploid, they will not result in healthy babies. In a 2020 study, Dr. Richard Scott, a former fertility doctor who is now scientific director at the Foundation for Embryonic Competence, a New Jersey-based nonprofit research center that also offers preimplantation testing, took biopsies from 484 embryos, but didn’t perform PGT-A on them until after they’d been transferred. This allowed his team to track what happened to the embryos, then check whether any of the PGT-A results diverged from reality. They found that not a single aneuploid embryo resulted in a live birth.

Such findings suggest PGT-A is “very, very powerful” when done well, Scott says. The problem, in his view, is that it isn’t always done well. Most labs are not doing such rigorous studies, and most companies use commercial tests that aren’t as well-validated as the one used in his research, Scott says. While most PGT-A testing uses the same core technologies, there’s variation in exactly how different testing platforms amplify and assess the DNA taken from the biopsied cells. If a validated PGT-A test used in scientific research is a sports car, Scott says, many commercially available platforms are like minivans: “They all have four wheels, a steering wheel, and an engine. But they’re different in almost every way.”

Still, Scott says most consumer tests do a good job of labeling normal embryos. There’s a small margin of error, as with just about any test—but in the vast majority of cases, he says, an embryo branded as normal really is. Scott believes the tests’ real “Achilles heel” is their false-positive rate: how often they brand embryos abnormal when they actually aren’t.

That prospect is concerning, because PGT-A is unusually influential for a screening test. If a cancer screen comes back with troubling results, doctors confirm them with other tests before a patient goes through intensive treatment. But PGT-A may be the final word on the fate of an embryo, since many clinics refuse to transfer abnormal ones—perhaps for the sake of their success rates and liability protections, or perhaps to shield patients from the emotional and financial costs of failed transfers. After a round of PGT-A testing, a patient may not have a single embryo their clinic is willing to transfer. They may try again, if they have enough time, money, and motivation. But they also may not.

That’s a devastating decision even assuming the testing is perfect. But some research supports Scott’s fears that it isn’t. In one 2022 study, a team of researchers in China retroactively analyzed genetic material taken from embryos that went on to result in live births. According to their testing, 11 out of 76 were aneuploid. The fact that these “abnormal” embryos resulted in babies, Scott says, suggests a significant percentage of embryos are being misdiagnosed.

Multiple research teams, including Grifo’s, have also re-tested embryos previously analyzed by PGT-A and at least occasionally found different results the second time around. Grifo says such discrepancies are rare—in his group’s study, 95% of embryos initially classified as aneuploid still were after repeated analysis—and are not reason to doubt the test. But other research suggests these inconsistencies matter. In one small 2024 study of 22 embryos previously considered “chaotic” (meaning they had six or more abnormalities), the researchers found a 14% euploid rate during re-testing. At many clinics, patients would be strongly discouraged, or even forbidden, from using chaotic embryos. But in the study, two that re-tested as normal resulted in live births.

Disparate results could point to varying accuracy among testing methods, Moragianni says. Or, if different biopsies from the same embryo are tested each time, the included cells could be different. “Every single cell of our body [does not] contain the exact same information,” she says. “It’s possible that we’re not exactly comparing apples to apples.”

Jaime Magnetico-Walsh, who is 42 and lives in Florida, has experienced that whiplash. In 2022, during their first IVF cycle, she and her husband were thrilled to end up with eight embryos, figuring at least half would be healthy. In reality, only one passed the PGT-A test. The couple transferred it, but Magnetico-Walsh’s pregnancy ended in miscarriage. The couple donated their remaining seven embryos to science and started looking into egg donors.

Months later, after receiving confusing bills for embryo storage, Magnetico-Walsh was shocked to learn that her fertility clinic had kept three of her mosaic embryos without her knowledge. “I was told they tend to keep these types of embryos just in case,” she says. “Until the couple has a live birth, they keep these because, potentially, they can be healthy babies.”

This was shocking news for Magnetico-Walsh and her husband, who had previously been told the embryos showed markers of Down syndrome and should not be transferred. Because of the back-and-forth, her clinic offered to re-test them with PGT-A for free. This time, two of the three came back as euploid—normal. “I was dumbfounded,” she says. She had donated her embryos to research, but “I felt like I was the science experiment.”

Magnetico-Walsh tried transferring one of those euploid embryos, but that pregnancy also ended in loss. She has her remaining euploid embryo in storage, as well as one from an egg donor, but feels paralyzed by the “emotionally, mentally, physically, and financially taxing” rollercoaster she’s been on, which prompted her to join the lawsuits filed by Freeman.

Biology is complex, and science evolves—especially, Moragianni says, in a relatively young field like fertility care. Patients who use cutting-edge technologies like PGT-A have to grapple with both realities, confronting both the randomness of reproduction and the fact that research on add-on tests like PGT-A is happening simultaneously to the tests being offered. That overlapping timeline leaves unanswered questions.

Five years ago, many clinicians would have advised a patient to discard mosaic embryos, says Dr. Rachel Weinerman, an infertility specialist and associate professor at the Case Western Reserve University School of Medicine in Ohio. “Now, I think the answer is, ‘Hold onto them, because there is a chance that they could be used,’” she says. “The question becomes, ‘What about the ones that tested completely abnormal?’”

Right now, she says, there’s little data to support using these supposedly nonviable embryos. But will that still be true in five or 10 or 20 years?

That’s a familiar question to patients like Katie Herrero, who is 42 and lives in Pennsylvania. In 2019, she and her husband turned to IVF after several miscarriages, hoping tests like PGT-A could shield them from additional losses. They were dismayed when two egg retrieval cycles together yielded only one chromosomally normal embryo, leaving Herrero and her husband with 10 that were somewhere on the spectrum of abnormality. They discarded those their doctors said had no chance at resulting in healthy pregnancies.

Later, however, Herrero learned in an online fertility group about a woman who had a baby using a reportedly aneuploid embryo that turned out to be a “complex mosaic,” or one with multiple chromosomal abnormalities, but some normal cells. Herrero wondered if any of the embryos she had discarded were in the same boat—and when she called her lab for more information, she learned that one was. Her lab and clinic didn’t get that granular in their reporting back in 2019, so she was told her embryo was aneuploid and, thus, unusable.

That experience prompted her to contact Freeman about the lawsuits against testing providers. Herrero hopes the litigation will help improve transparency in the industry that she trusted to make her dreams of motherhood come true—a dream that hasn’t yet been fulfilled.

Today, she says, she still thinks about what her embryos could have become. “Had I known what I know now,” she says, “there would be no way in hell I would have discarded those embryos.”

The post IVF Patients Say a Test Caused Them to Discard Embryos. Now They’re Suing appeared first on TIME.