Left in the cold: The unsupervised world of embryo freezing

On Monday afternoon, two men wheeled two large metal tanks into the lobby of a fertility clinic in Knoxville, Tenn., and left without saying anything. The tanks, shaped like antique milk cans and weighing about 120 pounds each, are typically used to hold frozen embryos and gametes left over from in vitro fertilization. But their sudden appearance at the offices of Rejoice Fertility on Monday triggered a call to the bomb squad, which required staff and patients to evacuate the building.

A representative of the Knox County Sheriff’s Office confirmed to WORLD that the tanks contained no explosives. The controversy over the tanks, however, could have fatal consequences for the frozen embryos they may contain. They are at the center of a dispute between two reproductive physicians—former business partners locked in a court battle over who should take responsibility for the tanks.

“It’s a very sad story, really, if you think about what’s going on here,” said Dr. Jeffrey Keenan, one of the physicians. “We’re definitely making and freezing way too many embryos in this country. And, you know, bad things happen."

Keenan set out years ago to make the practice of IVF more ethical and to give unwanted frozen embryos a chance at life. Dr. John Gordon eventually joined him to carry on his mission. Now, the two doctors are locked in a legal battle that risks the viability of frozen gametes and embryos whose genetic parents might or might not have relinquished their rights. WORLD investigated and found that the care of all frozen embryos in the United States—not just those in the Knoxville case—relies on a fragile honor system that leaves the embryos vulnerable to losing their identities or being inadvertently destroyed. While laws exist to guard against such errors in the handling of frozen embryos, the regulations have no teeth and are rarely enforced. The lack of oversight has perpetuated a system prone to error, abuse, and the destruction of vulnerable human lives.

Dr. Jeffrey Keenan (left) and Dr. John Gordon Photo courtesy of Dr. Jeffrey Keenan

A game of hot potato with frozen embryos

Keenan founded the nonprofit National Embryo Donation Center (NEDC) in 2003 as a way to preserve the lives of excess embryos conceived for in vitro fertilization patients like those he served in his clinic, Southeastern Center for Fertility and Reproductive Surgery. In embryo donation, couples who do not wish to give birth to their additional embryos but also do not want to destroy or donate them to scientific research can relinquish their rights. This allows doctors like Keenan to transfer the embryos into the uteruses of women who wish to become pregnant, giving the embryos a chance at life in a loving family. According to the NEDC website, the organization has helped 1,553 babies donated as embryos to be born.

The NEDC arranged for the donation of embryos from patients at Keenan’s practice and across the country. The embryo lab at Keenan’s clinic stored embryos donated to the NEDC alongside embryos and gametes from the clinic’s own patients. Many of the adoptive couples traveled to Keenan’s clinic for their embryo transfers.

In 2019, Keenan sold the clinic to Dr. John Gordon. Keenan continued to practice reproductive medicine at the clinic and kept his role as president of the NEDC. The clinic stored the NEDC’s donated embryos as before.

In 2023, Gordon renamed the clinic Rejoice Fertility. According to Keenan, that was the year that personal differences between the two doctors surfaced, including disagreements in how to run the clinic. The disagreements culminated in a parting of ways between Rejoice Fertility and the NEDC and a legal battle over custody of the donated embryos.

At first, Rejoice Fertility refused, according to Keenan, to hand them over to the NEDC, which could no longer use the clinic’s lab for storage. In a mediation agreement between the doctors, signed in August, Rejoice agreed to help move all donated embryos not already matched with Rejoice patients to the NEDC. The NEDC would pay Rejoice a total of $25,000 for the labor costs associated with moving and creating an inventory of the embryos. In October, Rejoice transferred four tanks and an inventory to the NEDC.

But in those tanks were 17 white plastic storage devices—either vials that hold a couple milliliters of liquid or tubes the size of coffee stirring straws. Keenan believes that, based on their size, at least some of them hold embryos. The NEDC says they did not appear in the inventory and, therefore, did not belong to the nonprofit.

According to the lawsuit, six of the devices have illegible labels. One is at the bottom of the tank “as if such was simply thrown into it or dropped.” Four devices or partial devices (which might be broken) have no identification, and six full or partial devices are “imbedded in or partially covered with ice crystals.” The 17th device, the lawsuit says, has a Rejoice Fertility patient’s name on the label. Keenan told WORLD the patient was his years ago but that Gordon became responsible for the embryos or gametes inside the device when he bought the practice. The NEDC consolidated the unidentified devices into two tanks. At that point, the dispute shifted to focus on who was responsible for the contents of those tanks.

Gordon told WORLD he was not aware there were devices at the bottom of tanks Rejoice gave to the NEDC. “When the NEDC embryos were taken by Dr. Keenan’s embryologist, my embryologist and their embryologist went through every single device,” he said. “They had a written inventory in front of them. They went through [it] for hours getting this exact handoff.”

He said the results showed that the inventory was accurate, and he denied allegations in the lawsuit that his clinic abandoned or mishandled any embryo for which it was responsible. Any irregularity about the contents of a tank “all predates me buying the practice,” Gordon said, and would have occurred under Keenan’s ownership.

Cryopreservation tanks at the new offices of the National Embryo Donation Center Photo courtesy of Dr. Jeffrey Keenan

The parties went to mediation on Dec. 6 but failed to come to an agreement over the unclaimed devices. Keenan told WORLD that he would “need to take some kind of definitive action” before leaving for Christmas vacation because he had no way to remotely monitor the tanks. On Monday, Keenan told WORLD he drove to Rejoice Fertility with his godson and an NEDC employee to drop off the tanks on the advice of his attorney. They put the tanks inside the building and departed. Keenan said the Rejoice staff did not know they were coming.

In an emailed statement, Gordon said that only a letter bearing the NEDC logo was attached to each tank detailing what was inside. “There was no chain of custody, joint inspection, or any notice to Rejoice that these tanks would be left in our lobby,” he said.

The staff called the sheriff’s department to report the tanks being dropped off, and officers called the bomb squad to examine them. Gordon did not respond to questions about where the tanks were as of Tuesday afternoon, but the sheriff’s office confirmed Tuesday that the officers left the tanks at the clinic after responding to the clinic’s call. It’s unclear what Rejoice plans to do with the tanks and the possible human embryos within them.

Frozen and forgotten

Anyone who has ever donated blood has seen the precision and care required when handling biological specimens. The government closely regulates and monitors laboratory procedures and quality control, while professional organizations set best practices.

But frozen embryos, whether donated or not, have almost none of the protection afforded to other biological specimens in the United States. At the regulatory level, there’s little oversight or meaningful enforcement that could prevent embryos in cryostorage locations throughout the country from ending up like those that may be in Knoxville: unidentified at the bottom of a tank.

In 1992, Congress passed the Fertility Clinic Success Rate and Certification Act. The law directed the Department of Health and Human Services to establish annual reports of the success rates of assisted reproductive technology programs, including IVF, and to develop a program for certifying embryo laboratories.

A notice outlining the regulations for certified embryo labs finally appeared in the Federal Register in 1999. It detailed requirements such as “an accurate and reliable method of tracking cryopreserved specimens” to ensure that each container could be identified. All labels, it directed, must be permanent, and the contents of each storage tank should be thoroughly documented in log books. Patient release forms and log sheets should always accompany the cryopreserved specimens when they are moved. The notice also established standards for labs to check the accuracy of their records and correct errors in specimen identification.

But following those regulations is voluntary, Charlotte Lozier Institute associate scholar Mary Harned noted in a November report about IVF regulations. There are no legal penalties for not participating in the government’s certification program or for falling short of the standards. Embryology labs are also exempt from the national regulations that apply to other types of labs.

Reproductive physiologist and former embryologist Craig Turczynski worked as the director of an embryology lab in the 1990s—the decade when the government first published many of the laws and regulations for IVF clinics. There seemed to be an understanding that embryology labs had to be inspected, he said, and that “there was only a certain amount of time before we could be fined or shut down if we didn’t.”

But the lack of enforcement, Turczynski said, communicates to embryology lab staff that they don’t have to meet the legal standards. “It is … even confusing in the laboratory,” he said. “Because you don’t know, well, do I really have to do this, or is it just recommended that I do this? And then over time, people have learned, ‘Well, I haven’t been doing it. No one’s come out to talk to me about it.’ So by word of mouth, you learn—no, you don’t really have to do it.”

Turczynski has since left the IVF field and is now an expert in fertility awareness methods and restorative reproductive medicine—approaches to reproductive medicine that involve examining the root causes of infertility.

Independent organizations such as The Joint Commission and the College of American Pathologists can accredit embryology laboratories, conducting biannual inspections to ensure the labs are meeting certain quality standards. But IVF labs are not required to pursue accreditation. Of the IVF clinics that reported their success rates to the CDC in 2021—the most recent data available—9% did not have lab accreditation. The CDC lists accreditation for another 2% as “pending.”

Rejoice Fertility’s IVF lab is among the other 89% that have accreditation. But, according to Gordon, the lab was not accredited before he bought the practice in 2019. Keenan said he didn’t know for sure when the lab first became accredited, noting that doing so would have been the responsibility of the embryologist on staff.

Some egg samples inside a smaller cryo storage container at the Aspire Houston Fertility Institute in Houston Associated Press / Photo by Michael Wyke

Even with the accreditation, Gordon and Keenan each said an inspection from Rejoice’s accreditor, The Joint Commission, would likely not turn up the devices at the bottom of the tank. Turczynski agreed. “That level of detail is not typical,” he said. “They’re not going to open up every tank and look inside and look for that kind of stuff. They’re going to spot-check some things.”

A spokesperson for The Joint Commission told me in an email that the organization checks for adherence to general laboratory standards, but they do not have a checklist of requirements specific to handling human embryos. Even if an inspection would have found the unlabeled specimens, the organization does not make their accreditation reports public. “Release of a healthcare organization’s report or its contents is at the discretion of the healthcare organization,” another spokesperson said in a separate email.

Although federal regulations say accreditation organizations like The Joint Commission have to make embryology lab inspection reports public, the provision remains unenforced, along with the rest of the regulations.

The accrediting agencies can revoke accreditation from IVF clinics that fail inspections, but they have no power to shut down those facilities. As Harned notes in her report, the CDC does not require IVF clinics to report accidents, adverse events, or legal or regulatory actions they have faced. “It is unlikely that the public will learn about any accidents or adverse events unless they are so egregious that they result in litigation and the litigation is reported in the news,” Harned told me.

Keenan and Gordon both said they have undergone routine inspections by the Food and Drug Administration in the past, but those inspections are focused on protocols and paperwork. “They don’t go to your tanks,” Gordon said.

The tip of the iceberg?

In a 2020 paper published in the journal Fertility and Sterility, researchers identified 133 lawsuits related to lost or damaged frozen embryos from 2009 to 2019. The paper noted that “No public or private body tracks errors or accidents aside from the popular media, and such cases tend to be settled within the legal system without further disclosure.”

The researchers concluded clinics should improve their labeling mechanisms and storage hardware and maintenance to avoid errors and accidents. States, they said, should also regulate the manufacturing and use of cryopreservation tanks. Turczynski agreed that implementing better human safeguards could help avoid some of these situations, but he said they’re impossible to eliminate altogether.

Turczynski said the general public has the perception that IVF involves foolproof technology at strictly run organizations, “but the simple fact is that they’re all run by humans. And you have good labs, and you have bad labs. … You have good plumbers. You have bad plumbers. … That’s the reality.”

Even the American Society for Reproductive Medicine—the professional organization responsible for establishing standards in the field—acknowledged in a 2020 paper that mislabeling, inadequate labeling, and inadequate inventory records are “known sources of errors” in embryo cryopreservation. It also explained that inventories of storage tanks are infrequent and not routine due to the risks of damaging embryos when removing them from liquid nitrogen.

Turczynski said he’d never heard before of a scenario quite like the incident involving the unlabeled devices at issue in the lawsuit between the NEDC and Rejoice Fertility. But he said it wouldn’t surprise him if it has happened before at other labs because of the inherent possibilities for human error. The plastic devices containing the embryos and gametes are small, and labs store them in liquid nitrogen, which is very cold. Handling the contents of the tanks requires gloves, but that also makes it easy to drop a device. Even labeling the devices entails writing on a small surface with a fine-tipped Sharpie marker—labels that can be hard to read through the liquid nitrogen in the tanks.

In Turczynski’s mind, the practice of artificial reproductive technology itself is morally dubious because it subjects embryos to absurd situations, such as being frozen indefinitely at the bottom of liquid nitrogen tanks. “It’s only because you're doing these things that you set up scenarios that really can’t be solved, right?” Turczynski said. “You couldn’t make them up.”