Two months after the cryotank failure in Cleveland, a memorial service was held on Mother’s Day for families whose gametes and embryos had been destroyed. In mid-May, I flew to Ohio to cover the service. I had spent the better part of a month investigating University Hospitals Fertility Center’s tank failure, speaking with several of the women and couples who found themselves facing an incalculable loss. When I called around to hear the disaster put into some context, the response was grim. “In my thirty years, I’ve never heard of this ever happening,” said Cindee Khabani, embryologist and laboratory director at Pacific Northwest Fertility in Seattle. Other seasoned lab directors told me the same, expressing their shock and horror. For days, fertility doctors across the country answered calls from worried patients: Are my eggs okay? Our embryos are safe, right?
It was every fertility clinic’s nightmare. Cryotank failures of this magnitude were a new kind of uncertainty, one not even I had considered. Most U.S. fertility clinics have backup systems to handle technical failures and make sure frozen specimens stay frozen. Embryologists I spoke to relayed the sorts of protocols they have in place—and hurriedly triple-checked when the news of the tank failures broke—in their labs: multiple backup cryotanks, freezers checked by staff members daily (at a minimum), specialized alarm systems that monitor tanks and their internal temperatures, and more. The breakdowns at the clinics in Cleveland and San Francisco both involved temperature and liquid nitrogen levels inside storage tanks, the details of which I’d soon glean. Both clinics were well known and reputable, their cryotanks and lab safeguards believed to be foolproof. But their systems had failed, resulting in the biggest such losses on record in the United States.
—
Kate Plants was thirty-one the first time she almost lost her fertility, upon learning she had ovarian cancer. Thank God I still have a uterus, she thought when her left ovary had to be removed. Kate and her husband, Jeremy, had been trying to conceive when she was diagnosed. Thank God I can still get pregnant. The second time Kate almost lost her fertility was two years later, when she learned the cancer had spread to her uterus. At the doctor’s office that day, the look of horror on her mother-in-law’s face said it all: This was bad, and Kate was in trouble. Three months later, doctors removed her uterus. Thank God we still have our embryos, she thought after the hysterectomy—she and Jeremy had frozen five before Kate underwent surgery. Kate had no chance of ever becoming pregnant, but she was comforted by the fact that a gestational carrier could carry the baby created by one of the embryos she and Jeremy had frozen. Then, the following year, the couple learned that their embryos, along with thousands of others, had been destroyed. And with this news, Kate’s fertility was gone forever.
In Cleveland the day before the memorial service, I visited Kate in the single-story mint-chocolate-chip-colored house she shares with Jeremy and their two kittens. We sat cross-legged on the floor of the nursery. The room had never been used, and now might never be, but being in it comforted Kate. She likened it to a sanctuary, a place where she sat and thought about children. “I don’t know what it’s like to see your own flesh and blood walk around and know how fulfilling that is,” she said, reaching for a hat she had crocheted for a baby she didn’t have. Her head hung low, strands of red-orange hair framing her pale face. Then, her voice softer: “I don’t think I want to admit to myself how badly I want a family.”
The nursery’s changing table dresser had been Kate’s own when she was a baby. Raised by a single mother, Kate had wanted children for as long as she could remember. Growing up, she’d pretend to cook for her younger half sisters while they all played with dolls. Stroking a kitten that had climbed into her lap, Kate told me how not being able to have biological children has made her feel as if part of her identity as a woman has been taken away. She was still struggling to process it all—her cancers, the destroyed embryos, the loss of her fertility—and most mornings woke feeling a mix of red-hot anger and deep sadness that left her exhausted before she even climbed out of bed. Protecting our eggs and embryos was their job, she thought. They’re the experts. That’s what they’re paid to do.
The service took place at a cemetery in Middleburg Heights, outside the city. The overcast sky made for an unusually cold spring day, even for Cleveland. An inscribed granite bench had been created to serve as a permanent memorial. In memory of the unborn / Before I formed you in the womb, I knew you, part of the bench read. Dedicated to the memory of the lost eggs and embryos of 2018. As it began to drizzle, I held the end of my umbrella with the inside of my elbow as I scribbled notes while interviewing patients at the service. They ranged in age from twenty-two to early forties. Some had frozen eggs and embryos prior to undergoing medical treatments that would render them infertile. Others had done so after going through IVF and having a child; their embryos on ice were their child’s future siblings, in safekeeping until they wanted to grow their family. Hearing their stories, I recalled something Dr. Alice Domar, a reproductive psychologist at Boston IVF, had said when we spoke a few days before I traveled to Ohio: “To lose embryos through what looks like human error just feels really unfair. And for the cancer patients, this is a catastrophe on top of a crisis.”
Halfway through the memorial service, the sky opened and huge raindrops fell on the crowd. “What we lost will not be forgotten,” Jeremy Plants said, speaking to the couples and families, multiple generations, huddled under umbrellas. For the Plantses, it was a day to put to rest, once and for all, their last chance at having a biological child. Jeremy’s voice broke as he continued: “There is a place for you to come, always.” A husband pulled his crying wife in close; a grandfather gripped his granddaughter’s hand while she stood quietly, draped in her father’s suit jacket. Those gathered had each received a glass memorial candle and they held them now, the flames flickering in the rain.
—
That night, I curled up in my hotel room and skipped dinner. I was on deadline and needed to file my story about the memorial service to an editor in New York. It had been a gut-wrenching day. I wrote late into the night, the sounds of my keyboard clicks mixed with the sound of the rain pattering against the windows. Grief—like forgiveness, like love—can be slow, hard work, I wrote. It is a characteristic of being human to honor the dead, but rituals sometimes have to take unusual forms. Equipment failure, deactivated alarms, in an instant, thousands of gametes and embryos destroyed. I had stood inside embryology labs like the ones in Cleveland and San Francisco where the nightmares occurred. What I hadn’t stopped to consider until now was what the tanks of liquid nitrogen inside those labs contained, really: fragile hopes, fervent desires, a thousand fraught conversations about preserving fertility—the whys, the hows, the what-ifs. Despite weeks of reporting, I struggled to grasp the magnitude of these families’ loss.
Reproductive Negligence
The Ohio and California incidents made it clear that the vulnerability of the storage process was another hidden risk of fertility preservation. Those twin catastrophes had led me down a new rabbit hole. Back home in Colorado, I spent weeks speaking with more experts—embryologists, lab directors, reproductive endocrinologists, lawyers—about what had happened, pressing them about the broader nature of regulation within the fertility industry.
Thanks in large part to the fact-finding efforts by reporters at local news outlets and state health department investigations, answers began to surface. The calamity in Cleveland was the result of both human error and equipment glitches. University Hospitals Fertility Center had known for several weeks prior to the incident that its cryotank that stored eggs and embryos wasn’t working properly. The clinic had been working with the tank manufacturer to correct the problem. The issue was the tank’s autofill valve, which controlled the liquid nitrogen level inside.[*1] While the autofill function was down, lab staff had been manually filling the tank for weeks by connecting it via a hose to a liquid nitrogen reserve container. But for several days before the failure, they couldn’t fill the tank using the hose—because the clinic had run out of reserve liquid nitrogen containers. Instead, as a workaround, lab technicians manually filled the tank by pouring liquid nitrogen directly into the top of it, rather than into the reservoir where the liquid nitrogen is normally pumped by the hose. As it happens, the top-of-tank manual pouring is an improper filling technique, and in this case it is likely what caused the temperature inside to rise to critical levels.
Additionally, a remote alarm system on the tank should have alerted a lab worker about the tank’s rise in temperature, but the remote alarm had been turned off. Had it been in use, someone likely would’ve been able to get to the cryotank and potentially fix the problem before the eggs and embryos inside were damaged. But no one was alerted. When the first employee arrived at the embryology lab early the next day, the tank’s local alarm was still blaring. By that point, the temperature inside the tank had risen to –32 degrees Celsius, destroying everything inside. In an investigation, the Ohio Department of Health found that, in addition to the clinic having issues with keeping records of its tanks’ temperature and liquid nitrogen levels, the fact that the clinic had only one designated point of contact for problems related to the tanks was also an issue. The health department determined that what happened at University Hospitals Fertility Center was largely preventable.[*2]
Explanations for the shocking news out of the California clinic were slower to materialize and predominantly came from subsequent legal proceedings. In 2021, a California jury awarded nearly $15 million to be shared among five people—three women who lost eggs and a married couple who lost embryos—in the tank failure, laying primary blame on the tank manufacturer. The jury determined that the storage tank had an equipment defect—a controller that was supposed to send alerts when the tank’s liquid nitrogen levels dropped—that was to blame for the liquid nitrogen level inside the tank falling too low. The jury found the tank manufacturing company 90 percent responsible and Pacific Fertility 10 percent responsible; about two weeks before the March 4 incident, the clinic’s lab director had disabled the tank’s controller because it had started malfunctioning, which caused it to send out false alarms.
Pacific Fertility Center was not a defendant in the three-week trial, having won a motion to send its claims to private arbitration.[*3] Neither was the clinic’s parent company, Prelude Fertility—the same Prelude we talked about earlier. Prelude added Pacific Fertility to its nationwide network of clinics in September 2017. Five months later, the incident occurred. Prelude’s ownership of Pacific Fertility went virtually unmentioned in the slew of news reports, but I immediately wondered if the major femtech company’s recent acquisition had influenced the clinic’s procedures and equipment quality and had any bearing on the tank failure. A few reproductive endocrinologists, also familiar with Prelude’s grabs, speculated, too. “When you’re about to be bought, you don’t invest in new tanks and lab equipment,” one told me. Her comment brought me back to the connection between the rapid expansion of the fertility industry’s retail-purchase model and the private-equity-backed deep pockets that spur such growth, the concern being that in the fertility and ART sector, as in other areas of medicine, private equity can lead to cutting corners and cutting costs any way a company can, while quality of care and appropriate clinical staffing levels fall to the wayside in favor of the bottom line.
Prelude owns Pacific Fertility’s laboratory, storage facility, and tanks. It owned Tank 4 at the time of the incident. The employees responsible for performing daily monitoring and maintenance of the tanks were Prelude employees. It remains unclear why the clinic didn’t have a functional autofilling mechanism to replenish the low liquid nitrogen levels or secondary monitoring, alarm, and response systems that would have detected the tank’s dangerous temperature rise. Backup systems and monitoring protocols are standard at most fertility clinics in the country. And while at most clinics it’s common to store frozen eggs and embryos belonging to hundreds or even thousands of patients together, some clinics spread individuals’ reproductive tissue across multiple tanks to avoid putting all eggs in one basket, so to speak.[*4]
I called up Dr. Michael Alper, medical director at Boston IVF, for more context. The reality is, he told me, that “any activity that involves humans and machines is associated with a failure or error rate.” Malfunctions happen; equipment breaks. Misdeeds and misconduct in the fertility industry are rarely intentional. But while some of the mistakes aren’t preventable, many are, especially those caused by human error and carelessness. I was troubled to learn that while mass incidents are rare, catastrophic errors in fertility clinics occur much more frequently than the public realizes. In addition to lost, discarded, or damaged frozen gametes, there are horrific cases of IVF mix-ups in which clinics have accidentally switched specimens so that women gave birth to someone else’s baby.[*5] Some of the mishaps make jaw-dropping headlines, but most do not. Sparse reporting requirements and the reluctance to disclose errors make it difficult to know just how frequently reproductive negligence takes place.
One study, published in 2022, determined that there have been at least nine major tank failures in the United States over the past fifteen years that have affected more than 1,800 patients. According to FertilityIQ, nearly 30 percent of all fertility patients will experience a clinical or clerical error at any given clinic. And a 2008 survey of U.S. fertility clinics—while not recent, it’s among the most comprehensive studies of its kind—found that more than one in five clinics misdiagnosed, mislabeled, or mishandled reproductive materials.[*6] Examples of what can cause frozen eggs to be damaged, be destroyed, be lost, or fail to develop, thus rendering them unviable, include power outages; mechanical or equipment failure, including loss of nitrogen or other tank failures; dropped materials, including vials, straws, and other containers used to freeze and store specimens; labeling errors; patient-specific differences in tolerance of gamete freezing; inventory record loss; natural and human-caused disasters; sabotage; and transportation or shipping accidents.
Millions of people rely on reproductive technologies to have children, and ART patients harmed by these sorts of accidents, errors, and negligence are often left without clear recourse. Victims often decline to sue. Those who do often settle out of court with undisclosed terms and nondisclosure agreements, keeping reproductive errors and lawsuit outcomes in the shadows. If a fertility clinic and/or its parent company are sued for losing or mishandling eggs and embryos, they are often shielded from liability because of the clauses in contracts patients have signed. It’s a stark contrast to the shiny marketing and visibility the Preludes of the world typically portray.[*7] Who, then, is in charge of ensuring that fertility clinics and the companies that own them act ethically and responsibly?
Businesses often learn their strengths and weaknesses from a disaster that spirals out of control. The tank malfunctions offered a rare point of entry into the fertility industry’s uneven regulations, but it wasn’t the pivotal moment it could have been, and the historic verdict in 2021—the first time a jury has awarded damages in a case involving the destruction of eggs and embryos—didn’t have far-reaching consequences. The lawsuits that played out in the public sphere weren’t nothing, of course, but as Dr. Shahine, the Seattle fertility doctor I’d spoken with a few times, put it: “You can sue as much as you want, but you can’t get your fertility back.”
An industry that creates and maintains potential life, and which has become quite a lucrative market in the process, has invited a great deal of responsibility upon itself. My next obvious order of business was to peel back reproductive medicine’s layers of oversight—or lack thereof.
—
Since the early 1970s, the United States has had policies in place that restrict federal funding for research involving human embryos. While that might sound like a clear illustration of strict regulation in the fertility industry, it’s not. Federal regulation tends to follow federal funding. Absent the funding, there’s no clear national guidance on this controversial area of research. Instead, states are left to develop their own policies, which range in their consistency, and privately funded fertility facilities operate without much consumer regulation or ethical oversight.
The complicated landscape surrounding human embryo research is emblematic of regulation in the U.S. fertility industry: at first glance fairly solid, but actually not great. Reproductive medicine in the United States is regulated by a complex patchwork of federal and state laws and self-oversight by the clinics.[*8] On the federal level, regulating ART falls mainly to two agencies.[*9] The CDC, which has jurisdiction over disease, collects and publishes data on ART procedures and birth rates but shirks other direct regulatory opportunities. Every year, clinics are required to report the outcomes and basic details of each ART procedure to the CDC; if they don’t, all that happens is the CDC puts them on a list of “non-reporting” clinics. The FDA limits its ART oversight to its general regulation of drugs, devices, and donor tissue; it does not regulate the actual procedures clinics do. Much of what takes place in an IVF lab falls outside the FDA’s purview, including, for example, the operation of the cryotanks that clinics use to store reproductive tissue.[*10]
What we have, then, is a few big-name governmental players that oversee aspects of ART, but with several caveats to their regulatory responsibilities, including enforcing standards. As for the more local level, most states don’t regulate ART to any substantial degree. This means that ART is largely self-policed, with some oversight from professional organizations. SART writes reports and opinions on various ART-related topics. ASRM sets forth best practices—including that fertility clinics should have policies in place regarding disclosure of medical errors involving gametes and embryos to patients as soon as such errors are discovered—but its recommendations are voluntary and sometimes ignored.[*11] The College of American Pathologists (CAP) visits fertility clinics every year or two to assess embryology labs for accreditation, which is optional in most states. Embryologists I interviewed respect CAP and its thorough checklists, and they care a great deal about their labs having CAP’s stamp of approval. But fertility clinics can choose whether their labs are accredited or not—again, not a requirement in most states. (The good news is, most are; to be a member of SART, a clinic’s embryology lab must be accredited by either CAP or the Joint Commission, another accrediting healthcare body.)
I was on the phone with a reproductive endocrinologist—who was on her Peloton at 6 a.m., her daily workout ritual before seeing patients—discussing the industry’s checks-and-balances processes when I got it: The reason fertility clinics can withhold mix-ups and errors is that they are accountable to no one,[*12] at least not in any official capacity. There is no repository for clinics’ incident rates. No government agency or authority seriously polices reproductive negligence. No central agency oversees fertility procedures. And the organizations the industry mostly listens to, such as ASRM and SART, lack the power to enforce their guidelines in any consequential way. Most of the time, the industry does a good job regulating itself. But when it doesn’t, the repercussions, as we’ve seen, can be enormous.
—
This is the moment in the darker parts of egg freezing’s saga where you and I both would like me to introduce an in-the-works solution, evidence of the fertility industry’s regulation failures and legal snarls working themselves out. The best I can do is this: The loosey-goosey regulation isn’t a complete nightmare, and while the negatives of the lack of oversight can be significant, there are positives, too. One is the risk of regulation coming in a form that’s really not wanted, such as anti-abortion legislation and unhelpfully strict embryo-destruction laws that could get fertility clinics in trouble, as discussed in chapter 9. In a post-Dobbs world, the inflammatory politics of conception and abortion have, as we’ve seen, already begun to encroach on ART and the ability of fertility doctors to do their job. Stricter regulation from lawmakers with anti-ART agendas could make the landscape far worse.
Another positive is freedom. Fertility doctors being allowed to do what their clinic and lab data shows offers the best chance of success for their patients is important. There aren’t uniform standards for freezing and maintaining eggs in the United States, unlike in most of Europe’s fertility clinics, and while the lack of micromanagement has its downsides, one benefit is that it encourages innovation. Reproductive medicine is a rapidly changing field, one that’s, ironically, often characterized by not having as much exact science as one might think. As embryologist Cindee Khabani, the lab director in Seattle, explained to me, the acronym for assisted reproductive technology, ART, is appropriate in a metaphoric sense: “The field of fertility has gotten better because people around the world have come up with new and better ways to do things that work for them,” she said. “And advances happen because of that.” The industry needs better maintenance standards and more transparency, but hopefully not at the expense of responsible scientific development or patient outcomes.
Your Eggs on Ice
The reproductive negligence rabbit hole the tank failures took me down was a wake-up call regarding the fertility industry’s regulatory vacuum. It also brought home the reality of eggs on ice and after the thaw, and had me considering the disposition decisions a woman freezing eggs or embryos has to make. Such decisions entail three options: preserving them in storage, discarding them, or donating them (whether to another couple trying to conceive, to science for research purposes, or, in the case of embryos, to an embryo donation program).
It can be incredibly difficult for a woman to decide when to stop storing her eggs or embryos. A question that therapists specializing in infertility often hear: Once you’ve invested in artificially extending the period in which you can decide to have a child, how do you go about deciding to end it? Even after having two or three healthy children, many women have a hard time deciding to pull the plug. With no easy answers when it comes to deciding to donate or discard, many patients simply stop paying for storage. Clinics will try to reach patients for years, after which they deem the eggs or embryos abandoned. If rent hasn’t been paid, so to speak, clinics still usually shy away from destroying abandoned reproductive tissue, even with signed consent forms from patients indicating what is to be done with their frozen specimens in the event of death, divorce, or nonpayment of storage fees.
One area where the issue of embryo disposition comes up often is in divorce cases, when couples must confront the tough question of what to do with their embryos. Often, legal disputes ensue. Say a wife and husband freeze embryos before the woman undergoes chemotherapy. A few years later, they divorce, and she wants to use the embryos, but he sues to prevent her from doing so. A judge upholds the agreement they signed at the fertility clinic, which said that the embryos could be brought to term only with the consent of both partners.[*13] Another scenario: A husband sues his ex-wife over frozen embryos the couple created together, seeking to make her a biological parent of his kids against her will.
The legal responses to such scenarios, and egg and embryo custody rights in general, vary from state to state. Most states recognize a fundamental right to reproductive autonomy when analyzing embryo disputes, with judges often ruling in favor of the person who does not want the embryo(s) used. But not always: In some states, the answer to the question “Who gets the embryos?” is “Whoever wants to make them into babies.” Back in 2018, Arizona passed a first-in-the-nation law stipulating that custody of disputed embryos must be given to the party who intends to use them for reproduction.[*14] The law explicitly instructs a divorce court to overrule any prior agreement made by the couple in favor of the spouse who wants to make use of the frozen embryos.[*15] In a 2023 ruling that drew criticism, a Virginia judge relied in part on a nineteenth-century law that defined enslaved people as property in a decision to allow a divorced woman to pursue using embryos that she shared with her former husband. Louisiana has a law defining embryos as “juridical persons” with the right to sue and be sued; women who undergo IVF cannot discard their unused embryos. It’s not a new law; it was passed in 1986. While the law has had minimal effects to date and fertility treatments continue to be offered in the state, Louisiana’s is the strictest embryo law in the country, and experts worry that it foreshadows what may be coming in many more states.
The legal gray area has grown more complicated since the fall of Roe v. Wade, but even before then, courts struggled to interpret laws regarding embryo custody and egg ownership. While it’s unclear how many eggs are on ice, there are an estimated 1.5 million frozen embryos currently in storage in the United States, most being held for use by the couples who’ve created them. As the number of controversies involving human embryos increases and as the field of legal precedent surrounding frozen reproductive cells continues to emerge, future laws concerning the disposition of embryos will most likely also fall along the same pro-choice/pro-life lines. The evolving discussion of embryo rights, it seems, is really only just beginning.
—
One day, I came upon a “Shouts & Murmurs” piece in The New Yorker titled “Your Frozen Egg Has a Question”:
I live in a freezer now, with a dozen of your other eggs, and you don’t. So I guess you are a “you” now, and I am a “me.” But am I still thirty-five, like you? Will I continue to be thirty-five until you defrost me? And if we’re going with that theory for a second—and I have temporarily stopped aging for the duration of the time that I am in this freezer, and am therefore currently in a state of suspended animation—does that mean I have temporarily ceased to exist? As you can tell, I’m freaking the fuck out in here. Not that that’s your problem! Do your thing. I just figured I’d touch base to see whether you had a sense of a time frame for all this. Like, if you had to predict how long you’ll be keeping me on ice, what would you say? Just a guesstimate is fine.
As funny as it was, the piece made me think about the process from a different point of view for the first time. I started wondering about all the frozen eggs on ice: How long could they stay there without going “bad,” and in this case what did “going bad” entail?
