By Ruben Castaneda
IN THE WEEKS AFTER storage tanks in two separate fertility clinics in different parts of the country failed, destroying hundreds and perhaps thousands of frozen eggs and embryos, Dr. Paul Turek fielded calls from a raft of patients. These were men and women who had eggs, sperm or embryos frozen at one of the banking facilities he uses in California. The anxious would-be parents asked whether their reproductive tissues were safe.
Despite the two incidents, there was no need to panic or lose confidence in the process, Turek responded. “Those patients whose gametes [eggs and sperm] were affected have already been notified,” he told concerned callers. “Don’t worry about your gametes. I think this is a once-in-a-lifetime event that’s unlikely to be repeated.” Overall, the checks and balances in this field of medicine are solid, and the two failures will likely lead to new levels of quality control and possibly new regulations, Turek and other fertility physicians say.
“These incidents, though tragic, serve as a humbling reminder that no technology is perfect, but they do spur the medical community to review internal quality control measures at their own facilities and help to ensure these circumstances occur only in rare circumstances,” says Dr. Joelle Taylor, a fertility specialist at IVFMD, which has five fertility clinics in Florida.
For clients, losing frozen gametes or embryos can be emotionally and financially devastating. It can cost tens of thousands of dollars to try to reproduce through a fertility clinic, costs that aren’t covered by most insurance plans. The average cost of in vitro fertilization in the U.S. is about $12,000, according to the Advanced Fertility Center of Chicago, a fertility clinic in Chicago. For example, at Pacific Fertility Center in San Francisco – where one of the failures occurred – IVF costs $11,595 and egg freezing is priced at $8,345 initially, with subsequent cycles costing $6,995, according to the facility’s website.
Reproductive medicine is growing rapidly, providing options for people who face infertility challenges. In 2009, at least 475 patients had their eggs frozen in the United States, according to the Society for Assisted Reproductive Technology, which aims to advance the standards for assisted reproductive technology. By 2015, that number had skyrocketed to 6,207, according to SART. Overall, 20,000 or so women in the U.S. have preserved their eggs in fertility clinics. In 2015, there were 231,936 assisted reproductive technology cycles performed in 464 reporting clinics in the U.S., which resulted in 60,778 live births, according to the Centers for Disease Control and Prevention.
IVF is usually effective, though not always immediately for all women, research suggests. A 2015 study by the Journal of American Medicine of nearly 157,000 women in the United Kingdom who collectively underwent more than 257,000 cycles of IVF treatment found the rate of live births after one cycle was 29 percent. The study indicated that many women who didn’t get pregnantafter the first cycle could succeed with persistence: The live birth rate after six cycles was 63 percent. The number of cycles a woman will need to go through before getting pregnant depends on a number of variables, such as her age, the cause of infertility, her health, her anatomy and hormone status, her pregnancy history and the previous number of IVF attempts she’s made, Turek says.
The two recent clinic failures occurred the weekend of March 3 and 4. At Pacific Fertility Clinic, the clinic’s lab director discovered during a routine check that the liquid nitrogen level in one of the facility’s steel storage tanks was too low, according to news reports. A lack of sufficient liquid nitrogen prompts the temperature in these steel tanks to increase; in turn, higher temperatures can damage tissue stored in vials called cryolocks. Each vial can contain up to three eggs; embryos – that is, fertilized eggs – are stored separately. Clinic officials didn’t say how many eggs and embryos may have been damaged. They did, however, acknowledge that the tank held several thousand eggs and embryos.
The other failure occurred in Cleveland, at the University Hospitals Fertility Center. Officials at the facility reported an estimated 4,000 frozen eggs and embryos were damaged when the temperature in one of its tanks dropped to an unsafe level. Clinic officials sent a letter to patients blaming the damage on human error. The remote alarm on the cryo storage tank that failed was turned off, the letter stated. The alarm should have alerted clinic workers to fluctuations in the tank’s temperature. Clinic officials said they don’t know who disabled the alarm. The letter said it is unlikely any of the frozen eggs and embroyos are viable.
At least 18 sets of plaintiffs have filed lawsuits against the two clinics.
Reproductive medicine is regulated by “a complex patchwork of federal and state licensing and self-regulating by the clinics themselves,” says Sean Tipton, chief advocacy, policy and development officer at the American Society for Reproductive Medicine. ASRM is a multidisciplinary organization dedicated to the advancement of the science and practice of reproductive medicine. This oversight helps ensure that protocols at fertility clinics are up to snuff and the equipment is well-maintained, Turek says. Nonetheless, failures can occur. If you’re considering a fertility clinic to help you conceive, experts suggest these eight strategies to improve your odds of a good outcome:
- Do some research. Not all fertility clinics are alike. “Your local fertility center may not be the best center around, and it’s worth doing your homework,” says Dr. Thomas A. Molinaro, a reproductive endocrinologist at Reproductive Medicine Associates of New Jersey in Eatontown, New Jersey. He recommends logging onto SART’s website: sart.org. The federal government requires fertility clinics to report their IVF treatment cycle success rate, and you can find those statistics on the site. It also has a tool that allows prospective patients to search for fertility clinics by ZIP code, state or region; plus, women can plug in information such as their age, height, weight and how many prior births they’ve had to predict their chances of success with assisted reproductive technology. If you’re doing this kind of research, plenty of resources are also available on resolve.org, run by Resolve: The National Infertility Association, which is a nonprofit nationwide network that promotes reproductive health and works to ensure equal access to all family-building options for men and women experiencing infertility or other reproductive disorders.
- Trust your instincts.When you’re considering a fertility clinic, keep in mind it provides a service and evaluate it the way you would other providers you might hire. “I think patients’ gut feelings are usually pretty good,” Turek says. “Your gametes are one of life’s most precious commodities. You use a lot of different factors to decide who’s going to handle your retirement or keepsake your jewelry. Use the same sorts of input for this precious resource. Consider how the clinic’s staff talk to you, what they say – how professional does the care feel? Use all of your senses. Is the care personalized and professional enough so you feel comfortable?”
- Don’t choose a clinic based solely on insurance coverage.Currently, 15 states mandate insurers cover infertility treatments, including IVF. “Although it’s tempting, it’s not necessarily the best idea to pick a clinic based on your insurance coverage,” Turek says. “The best thing to do is to base your decision on the performance of the individual clinic, which is knowable.”
- Be wary of programs that aren’t transparent about their results on their website. Most programs are proud of their results and will list them on their website, Turek says. If a facility doesn’t list its outcomes or appear to be fully transparent, consider it a red flag. It may mean the facility doesn’t have good results.
- Ask how many assisted reproductive procedures the facility does.“Volume can matter in IVF,” Turek says. “In many areas of surgery, volume is a sign of expertise. It’s not a hard-and-fast rule, but it is a consideration when evaluating program quality.” Inquire about how many procedures the facility does each year.
- How experienced are the providers, how well-trained are they and how long have they been there? As with other fields of medicine, experience matters in reproductive medicine, Turek says. “Experience is a combination of knowledge and wisdom, and like good wine that takes time to gain.” Providers should be fellowship-trained and board-certified in the field, both of which are the standard. Also inquire how long the medical providers have been at the facility. If there seems to be high staff turnover, there could be leadership and organizational issues at the clinic.
- Consider what you’re getting for your money. Price is always a consideration, but you should also weigh what you get for your money. “It’s not about the cheapest program, it’s about what you’re getting for your money and that’s a value proposition,” Turek says. “If you spend 25 percent more for a 50 percent higher pregnancy rate, that could be a better deal for you.” Look for clinics that can offer the latest treatments, Molinaro advises. These would include blastocyst transfer, preimplantation genetic screening of embryos and single embryo transfer. This information is available on sart.org. Good clinics with high success rates may cost more up front but may get you pregnant faster and at a lower cost in the long run instead of paying for multiple treatments.
- Join a support group. For people with fertility challenges, the quest to have a child is a journey, says Dr. Maria Costantini-Ferrando, an attending physician at the Reproductive Medicine Associates of New Jersey’s facility in Englewood, New Jersey. These men and women typically grapple with psychological and physiological issues, and being part of a support group can help with both. “A support group is really essential,” Costantini-Ferrando says. “One of the reasons people drop out of fertility treatment is because it’s too stressful. Being part of a support group can reduce that stress. Voicing your experience with other people who are facing the same challenges will decrease the level of anxiety and distress associated with the process.” You can also learn about treatment options and coping strategies from other people in your support group. “It widens your universe of knowledge,” she says. Fertility clinics can typically refer you to their own support groups. Plus, Resolve’s website lists options nationwide and provides information on how to start your own support group.