Tiny lab-grown embryos have always faced a perilous journey from conception to a baby. But there was one place where they seemed safe and sound: the freezer.
Until now. Two major and near-simultaneous failures at fertility centers is sending shock waves through the fertility industry, triggering questions about the technology and oversight of egg and embryo storage, which is increasingly popular — and largely self-regulated.
Coolant leaked from freezers at both San Francisco’s Pacific Fertility Clinic and Cleveland’s University Hospitals Fertility Center, putting precious eggs or embryos at risk.
“We need to have a better understanding of where the weaknesses in the system are,” said Dr. Ryszard Chetkowski, director of the Alta Bates Hospital fertility program in Berkeley. “People value these embryos tremendously.
“We must get at the bottom of what caused the failure — why these two tanks failed and thousands of other tanks haven’t,” added Chetkowski, who cares for patients with tissue stored at the San Francisco facility.
Souls on ice, an estimated 1 million embryos are now in storage in the U.S. Some tech companies, like Facebook and Google, offer it as an employee benefit.
Fertility treatment isn’t cheap. A single cycle of fertilization costs about $12,000, but drugs and related procedures push the total price to more than $20,000 per cycle.
Until recently, the freezing-thawing cycle was very risky, due to the creation of ice crystals. Only about 60 percent of embryos made it through the process intact. But a new technology called vitrification, which uses antifreeze and much faster freezing, avoids crystal formation. An estimated 95 percent of embryos are healthy when thawed.
Now there are new anxieties about storage.
Although no one yet knows what went wrong, experts suspect there was a leak in the seal of the tank that holds liquid nitrogen, where frozen embryos are stored. But why didn’t a sensor sound an alarm? Was that broken, also?
There’s no known connection between the two episodes. The tanks are believed to have different manufacturers. The San Francisco tank was relatively new, only about six years old.
The tanks that contain frozen embryos are monitored seven days a week, according to the Pacific Fertility Center. Each tank gets a physical inspection daily, looking for problems or signs of problems. The quantity of nitrogen in the tank is assessed as a means of monitoring for a possible slow leak or an impending tank failure. The nitrogen in the tank is topped up daily, since it continuously evaporates at a slow rate.
Electronic tank monitoring uses different sensors to ensure that tanks perform to specifications. Probes attached to the tank are supposed to detect a rise in temperature within the tank, or a drop in the level of liquid in the tank. Sensors are connected to a telephone alarm system that is designed to alert staff to a problem.
According to the center, the problem was discovered by the clinic’s laboratory director, who noticed during a routine check of the steel storage tanks that the level of liquid nitrogen in one tank was too low. How much the failure damaged the eggs and embryos remains unclear. There’s no way to know until the embryos are thawed.
The incident has renewed calls for government oversight.
In the U.S., the federal government exerts relatively little control over fertility treatment. While human tissue is regulated by the U.S. Food and Drug Administration, that means mostly that it must be tested for diseases like HIV, Hepatitis B and C, chlamydia, and gonorrhea — and labeled, so samples don’t get mixed up.
And U.S. Centers for Disease Control track outcomes, requiring that clinics report the basic details of each treatment cycle—such as outcomes, infertility diagnosis, number of embryos transferred, use of fresh or frozen embryos, donor or non-donor eggs.
The major lab oversight comes from professional organizations such as the American College of Pathologists and the American College of Pathologists and the American Society for Reproductive Medicine.
On Monday, the Society for Reproductive Medicine said it plans to review the incidents with the clinics and their equipment suppliers this week, then will gather experts to make recommendations. “In the meantime, infertility clinics around the country have been double and triple checking their own procedures and equipment to ensure everything is working properly,” it said.
While a license is required by the California Department of Public Health, it requires only names of employees, a list of tissue types stored and a written copy of policies and procedures.
There is no statutory national body, such as Australia’s Reproductive Technology Accreditation Committee or England’s Human Fertilization and Embryology Authority, according to Dr. G. David Adamson, Director of Palo Alto Medical Foundation’s Fertility Physicians of Northern California.
In the U.S., reproductive technology “has been characterized by the absence of a socialized healthcare system, lack of centralized government or financial oversight, and the proliferation of a large number of clinics to meet market demand,” wrote Adamson. “Although some of these clinics are based in universities, which are operated under state oversight, and some are in private academic centers, many function as private medical practices.”
“The labs and tanks themselves are checked for hazardous materials, not a through examination of equipment, to see whether there’s risk of significant failure,” said bioethicist Art Caplan, professor and founding head of the Division of Medical Ethics at NYU School of Medicine in New York City. “I’m sure they keep logs — but that’s not enough to say the thing is going to fail, only that it did fail.
“There are five million rules about how abortion clinics operate,” he said. “But when it comes to infertility clinics, politicians don’t like to go there at all.”
There is a general need for more regulation, said Naomi Cahn, Professor of Law at The George Washington University Law School and author of the book Test Tube Families: Why the Fertility Market Needs Legal Regulation.
“But as to whether this particular failure show shows the need for more regulation, it is unclear. We don’t yet know the source of the malfunction,” she said. “We can imagine more frequent monitoring of these tanks. Might that have prevented this from happening? That is unclear.
“It does show the risks of the fertility industry that are inherent in these kinds of storage facilities,” she said. “No technology is perfect. Machines sometimes fail.”