America’s IVF Failure

A sperm donor fathers more than 150 children. A cryobank misleads prospective parents about a donor’s stellar credentials and spotless health record. A cancer survivor’s eggs are stored in a glorified meat locker that malfunctions, ruining her chance at biological motherhood. A doctor implants a dozen embryos in a woman, inviting life-threatening complications. A clinic puts a couple’s embryos into the wrong woman—and the biological parents have no recourse.

All of these things have happened in America. There’s no reason they won’t happen again.

When the Alabama Supreme Court ruled in February that frozen embryos are children, effectively banning in vitro fertilization, it produced an uproar. In response, the state legislature quickly granted IVF clinics sweeping immunity, regardless of what egregious errors they may make. This is the way the debate over assisted reproduction has typically played out in the United States: A vocal minority asserts that embryos are people and calls for total bans of reproductive technology; meanwhile, the industry goes unregulated, leaving prospective parents with few safeguards and even fewer options when things go wrong. Unconsidered are all the patients who want IVF to be legal and also want it to be regulated like any other medical practice.

[Read: The people rooting for the end of IVF]

People across the political spectrum should be concerned about how underregulated fertility care is. The stakes are high. An estimated 9 percent of American adults have used some form of assisted reproduction by the end of their childbearing years—including in vitro fertilization, intrauterine insemination, and donor gametes. One out of every 50 babies born in the United States was conceived via IVF. Many of the hundreds of thousands of people who show up at clinics each year are desperate; the tissues that they entrust to these clinics frequently represent their only hope of biological parenthood. In a country that claims to care about families, the dearth of regulation represents a failure that cuts across party lines.

Kaitlyn Abdou spent $165,000 on IVF and never had a child. Although she experienced multiple miscarriages using artificial insemination and paid for an insurance plan with full fertility benefits, her insurer denied her coverage because, as a single, queer woman, she didn’t meet Massachusetts’s definition of infertility: a man and a woman who are unable to conceive after one year of trying. Like thousands of other Americans, Abdou fell through the cracks of inconsistent state-by-state mandates. So she sold her house to pay for the treatments.

At the clinic, CNY Fertility, Abdou struggled to understand her options, because there were so many different potential add-ons to her treatment, many of which seemed to be backed by shaky science. Without large-scale studies and clinical best practices to consult, Abdou felt, like many patients, that the best medical information came from anecdotes in Facebook groups. After four months of doctor-ordered human-growth-hormone injections—a common tactic to try to improve egg quality, though not FDA-approved—Abdou’s right ovary burst during an egg retrieval. Despite the pain, the clinic sent Abdou home. She woke up in agony and then headed to the emergency room, where she learned that she was bleeding internally. “If I had slept through the night,” she told me, “I probably would have bled out and died.”

At times, Abdou wondered if the lab had mishandled her embryos; when several blastocysts that had been developing well were suddenly not viable, Abdou couldn’t tell if the reason was chance or poor protocols. No one warned her that she might continue to lose one pregnancy after another: Over three years, she had five miscarriages before giving up. Her care team cited the importance of “staying positive.” But with each round of treatment, the clinic made more money. Abdou received no guidance about when to stop or information about how likely she was to succeed. (CNY Fertility did not respond to a request for comment.)

After hearing horror stories from patients at other clinics, about freezers malfunctioning and doctors withholding basic information on embryo quality and ultrasound results, Abdou feels like her experience could have been far worse. “I was lucky,” she said.

The U.S. fertility industry is unique in its lack of rules and oversight, compared with other countries and other fields of medicine. From the field’s inception, lawmakers have declined to regulate it. In the 1980s, anti-abortion conservatives blocked initial efforts at IVF regulation because of discomfort with the creation and destruction of embryos, as well as the perceived threat to morality posed by decoupling sex and reproduction. Although Democrats led the congressional hearings fighting for oversight, liberals also feared that restricting what could be done would limit who could access it, and would end up excluding single people and same-sex couples (who are, in fact, barred from accessing IVF in many other countries, including France, Italy, and China).

Dov Fox, a reproductive-law professor at the University of San Diego and the author of Birth Rights and Wrongs, told me that Congress “just threw up their hands and said, ‘We’ll let the private sector sort it out.’”

American consumers were left with the barest of federal rules—one law requiring testing donor sperm and eggs for sexually transmitted diseases, another requiring clinics to report their pregnancy and birth rates—with no penalties for noncompliance. Additionally, the FDA will not approve techniques that genetically modify embryos. In this vacuum, a patchwork of state statutes and case law developed, creating “a confusing legal tangle” for patients, according to Margaret Marsh, a professor at Rutgers University and a co-author of The Pursuit of Parenthood. For the most part, the industry is self-regulated by professional bodies that have no enforcement power, besides referring reckless doctors to state medical boards.

Ironically, by opting out, the federal government played an enormous role in shaping the fertility industry and causing it to diverge from other medical specialties. In 1995, two Republican members of Congress added an appropriations-bill rider that banned federal funding of embryo research—a provision that still stands. In most medical fields, government grants get new treatments off the ground, which leads to rules, best practices, and data-collection guidelines meant to serve the public interest. In assisted reproduction, this is all absent. Wanda Ronner, a professor of obstetrics and gynecology at the University of Pennsylvania School of Medicine, and the other co-author of The Pursuit of Parenthood, told me, “We don’t even have independent, peer-reviewed research funded by the NIH to say ‘What’s the most effective way to make sure the embryo is okay to transfer?’ or even ‘What temperature to freeze the embryos?’ We don’t even have a lot of information on these fertility drugs and how they impact you.”

Basic facts continue to elude researchers. “We do not even know how many frozen embryos we have in this country,” Marsh told me. The last count was performed 20 years ago and found 400,000. Today, “we have no idea.”  

Unlike new cancer drugs and novel surgeries, which go through multiple rounds of trials before receiving FDA approval, “a lot of innovation in fertility is clinical,” Sonia Suter, a law professor at George Washington University and a co-author of Reproductive Technologies and the Law, told me. Usually performed on small samples of patients, many of these experiments “don’t even require going through the research process.” This means patients like Abdou are left with sparse information about efficacy; instead, they are often test subjects themselves.

Because of the federal research-funding ban, Fox told me, “assisted reproduction grew up less as a medical practice or research than as a business activity.”

[Yuval Levin and O. Carter Snead: The real lessons of the Alabama IVF ruling]

Ordinary safeguards are often absent. Every area of health care has so-called never events: catastrophic failures that are never supposed to happen, such as amputating the wrong limb or forgetting a scalpel inside a patient’s abdomen. The government requires hospitals to report these incidents—but no agency tracks reproductive disasters. Whereas donor blood is usually barcoded and drug storage frequently requires fingerprints to unlock, Fox points to multiple cases of egg and sperm banks labeling tissue with pen and paper.

This lack of oversight extends into almost every aspect of assisted reproduction. The U.S. has no federal limits on how many times a man can donate sperm—leading to donors with hundreds of offspring and a rise in accidental incest between donor-conceived half-siblings. No one holds cryobanks responsible for the information that they provide customers. One bank promoted its most popular donor as a genius athlete with a Ph.D. and perfect health. In reality, he was a college dropout with a rap sheet. According to Fox, who produced a podcast about the case, “They know that nothing is going to be checked and that they can make more money if they lie.”

Sex selection, banned in almost every other country, is big business in the United States. Genetic tests paired with IVF enable prospective parents to identify and implant either male or female embryos. This is illegal in Canada, Australia, and every European nation besides Cyprus, except in rare cases to avoid passing on X-chromosome-linked diseases. But in 2018, an estimated 75 percent of American clinics offered sex selection for nonmedical reasons, with the majority allowing people to undergo IVF solely to pick a son or a daughter—despite a 1999 condemnation from the professional body overseeing reproductive medicine. (It has since updated its position to a neutral stance.) Jeffrey Steinberg, a pioneer of the procedure who practices in California, estimates that trait selection comprises 5 to 10 percent of the American IVF market, or up to $90 million annually.

New polygenic tests—which sequence embryos’ genomes and promise parents the ability to select those at the lowest risk for obesity, bipolar disorder, and other conditions—are attacked by critics as “Eugenics 2.0” yet are completely unregulated by the FDA. Most countries ban these tests, along with their marketing claims. But in the U.S., parents can use raw genetic data to pick embryos based on whatever criteria they want. They can even go online to find dubious advice about how to choose the smartest, tallest, most attractive offspring.

Steinberg defended the status quo, telling me that regulation risks “putting the handcuffs on scientists.” He added, “If there’s anything society should have learned, it’s Keep their hands off of people’s reproductive choices.” Like many other fertility specialists, Steinberg uses the rhetoric of choice, borrowed from the abortion debate, to argue for loose regulations—a tactic that might backfire and imperil IVF as abortion restrictions mount across the nation.

Despite its shortcomings, the U.S. fertility industry is booming. People travel from all over the world to get care here. Some seek services that are illegal elsewhere, such as sex selection, the purchase of donor gametes, and commercial surrogacy. Others can’t get care in their home country because they are single, queer, older, or ill.

When negative outcomes arise, one could argue “that’s a price we’re willing to pay for a medicine of miracles that fills empty cribs and frees families of terrible diseases,” Fox said.

No matter how hard clinics try, Steinberg said, mistakes are the cost of doing business. “Embryos are treated with the utmost respect, just like humans,” he told me. “But it’s never to say that a human doesn’t get sucked out of the window of an airplane or that an embryo doesn’t get dropped on the floor. It can happen. ... Life is life. Not everything will be absolutely perfect.”

Reproductive technology can bring prospective parents great hope—which makes its failures especially brutal.

Georgette Fleischer believes that she was the victim of fertility fraud. Fleischer quickly conceived her first child using donor gametes, but when she came back to give her six-month-old daughter a sibling with remaining gametes, New Hope Fertility Center, in New York, couldn’t produce a single viable embryo. According to a lawsuit Fleischer filed, New Hope denied her access to her medical records multiple times; when she finally got them, she learned that previously healthy sperm were now nearly all immotile or deformed. (The clinic created the embryos anyway, without informing Fleischer.)

Eventually, Fleischer found a paper in the prestigious journal Fertility and Sterility published by the chief executive of New Hope, John Zhang, that documented his trials in freeze-drying and reconstituting sperm. The dates overlapped with Fleischer’s treatment, and the consequences resembled what had happened to her sperm, leading Fleischer to believe that Zhang had experimented on her tissue without asking her.

“I was the perfect guinea pig,” Fleischer told me. She believes that she was targeted because she was an older single mother, reliant on both donor eggs and sperm. But even if Fleischer can prove that she was the victim of Zhang’s experimentation, only nine states have laws against experimenting on reproductive material without a patient’s consent. New York isn’t one of them.

Fleischer reported Zhang to the FDA and the New York Department of Health, but she may never know the outcome. Her lawsuit laid out 12 claims; the judge dismissed all but medical malpractice and lack of informed consent. She’s appealing, claiming that the damage extends far beyond those narrow categories. But these cases are so hard to win, Fleischer told me, that she couldn’t find a lawyer and has had to represent herself. (In court filings, New Hope Fertility Center and Zhang denied Fleischer’s allegations; neither party responded to multiple requests for comment.)

Fleischer exemplifies the vulnerability and desperation that many fertility patients feel, turning to technology when they can’t conceive because of age, cancer, risk of heritable diseases, sexual orientation, or lack of a partner. Clinical failures “leave those people who were already disadvantaged doubly or triply so,” Fox said.

Marsh, the historian, told me that under the current system, “infertile people are being robbed.” A lack of clear information means that patients don’t know how to get the best care, scrambling while time runs out. Ronner, at Penn, said she and Marsh believe that reactionary, piecemeal approaches will only make things worse: “We worry that without clear national policies on assisted reproduction, access to IVF and control over embryos could become as difficult in many states as access to abortion already is.” She added that although IVF is available now, “that could change in a minute.”

A decade ago, the CDC created an action plan for addressing infertility as a public-health issue; Ronner and Marsh point to its suggestions as a great place to start reform. They also advocate for creating a “distinctly American” version of the United Kingdom’s Human Fertilization and Embryology Authority, an independent body that oversees both research and clinical care.

[Read: The calendar of human fertility is changing]

Most other industrialized nations provide, subsidize, or mandate insurance coverage of IVF, which gives them a strong incentive to regulate the industry. This could eventually happen in the U.S.; 21 states and the District of Columbia now require insurance to cover some infertility treatment. But even that assistance is uneven: Arkansas, one of the few states to explicitly mandate IVF coverage, restricts that mandate to heterosexual married couples only.

Although abortion remains a controversial political issue, the response to the Alabama Supreme Court’s ruling—and the state’s swift passage of a law to protect IVF—shows broad support for family-building technology. According to a recent CBS/YouGov poll, 86 percent of Americans believe that IVF should be legal. Perhaps the uproar in response to the Alabama decision provides an opportunity to protect patients and provide guardrails around the treatments that create much-wanted children, without leaving regulation to the whims of the marketplace or reactionary rulings.

America already has a model for regulation: the military. Eight military hospitals provide IVF at about a quarter of the average cost. Security protocols are strict, according to Donald Royster, a retired Air Force colonel and former head of the military IVF center at San Antonio Military Medical Center. Expensive add-ons, including preimplantation genetic testing, are far less common, keeping costs down while dodging thorny ethical questions.

Patients also need specific ways to seek relief when things go wrong, according to Fox. Legislation and jurisprudence should recognize the special status of eggs, embryos, and sperm, instead of pretending that they are “lost property or killed persons or a broken contract or even medical malpractice.”

Failing to acknowledge this only politicizes and imperils fertility care. Patient safety, accurate advertising, and legal accountability should not be partisan issues.