Tours of Ohio fertility clinics show procedures in place to safeguard eggs, embryos (photos, videos) - http://allcharts.co.za | Breaking News

March 25, 2018 9:05 am
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CLEVELAND, Ohio — Every weekday morning, embryologist Keith Whitacre lifts the lids on two fertility freezers that look like beer kegs on wheels. Vapor rises from the liquid nitrogen inside, obscuring the frozen embryos and sperm submerged in the super-cold nitrogen at the bottom of the tank.

These tanks contain embryos and sperm collected from patients at Fertility Unlimited, an in vitro fertility clinic in Akron. These reproductive tissues are kept at -196 Celsius until they are thawed and used to help infertile couples have children.

If Whitacre leaves the freezer lid open for more than a few minutes, the temperature inside the tank rises and a beeping alarm combined with a mechanical voice raises an alert.

“It’s going to call my cellphone,” Whitacre said, referring to the alarm’s call-out system that automatically rings the cellphones of lab technicians. He replaced the lid, and the alarm quieted. The Plain Dealer toured the facility earlier this week.

“We are always observing that the tanks are functioning properly and the samples are being well protected,” he said.

Security and safety protocols at IVF labs across Ohio and the nation are gaining increased scrutiny in the wake of two recent failures at fertility clinics this month.

About 2,000 eggs and embryos were potentially damaged over the weekend of March 3-4 at University Hospitals’ Ahuja Medical Center in Beachwood when a storage tank had a temperature fluctuation, affecting about 700 patients, the hospital has said. Multiple lawsuits have been filed against UH in Cuyahoga County Common Pleas Court, and the hospital system is under investigation by two accreditation organizations and the Ohio Department of Health. UH has said it is investigating the incident, but has not commented further.

On the same day UH discovered the temperature fluctuation, the Pacific Fertility Center in San Francisco also found one of its storage tanks leaked liquid nitrogen, and eggs and embryos had been damaged.

STORAGE SAFEGUARDS

At Fertility Unlimited, office doors are locked and alarms are set to ring at a temperature well below the point where the tissue samples would be damaged. “There’s wiggle room built into it,” Whitacre said. 

The wall-mounted alarm is hooked to a backup generator, and the automatic-call machine has a battery backup. “It is a fairly redundant system,” Whitacre said. “Everything failing would be surprising.”

Whitacre said he believes similar alarms and back-ups were in place at University Hospitals, which begs the question of how an increasing temperature in UH’s fertility freezer wasn’t detected sooner.

Whitacre and the doctor in charge at the Akron facility, Nicholas J. Spirtos, have discussed ways to ensure lab safety, such as checking on the life span of the lab’s freezers and when they will need to be replaced. If one freezer failed, Fertility Unlimited could quickly move frozen eggs and embryos to a second freezer, Whitacre said.

The Cleveland Clinic also has several safeguards in place to ensure the safety of reproductive tissue stored there, Tora Vinci, senior manager for public and media relations, wrote in an emailed statement. However, the Plain Dealer was not permitted to tour that facility.

These safeguards include a temperature probe that continuously monitors and records tank temperature onto a computer, and tanks and temperature log that are checked daily, Vinci wrote. Liquid nitrogen is added to each tank twice weekly so that all embryos and ovarian tissue are completely immersed with at least 13 inches of liquid nitrogen above them.   

Each tank has a 24/7 alarm system if there is a temperature problem. “A prompt response system is in place,” Vinci wrote.

“We continuously reassess our safeguards in the lab to make sure that we have state of the art approaches to cryopreservation,” Vinci wrote.

At Reproductive Diagnostics, in Columbus, dozens of small storage tanks are tucked into every corner of the fertility lab.

Dr. Bill Baird, laboratory director, opts to use multiple smaller storage tanks to reduce the possibility of a widespread loss of eggs and embryos possible in larger tanks. The staff manually measures liquid nitrogen levels every day and doesn’t rely on an auto-fill system that could potentially malfunction, Baird said.  

The Columbus lab’s alarm system is set to trigger an alert if the temperature in a tank rises about 20 degrees, which is still well below the threshold for damage to eggs and embryos. The system only stops calling when a code is entered.  

Baird doubts the workers in UH’s lab are any less careful than his team and assumes that lab uses similar precautions as his own. Yet, despite all of the safeguards, something “catastrophic” still happened in Cleveland and San Francisco. It is not clear if the incidents are similar or related.

“We’re all very concerned to learn what happened and hope to learn from it and make sure it doesn’t happen to anyone else in the future,” Baird said.

He, and others in the industry, are hopeful those involved in investigating the incidents share their findings. 

“Share it. Tell us what happened,” Baird said. 

It’s impossible to know the viability of the eggs and embryos at UH until there’s more information about how severe the temperature fluctuation was, the size and the type of the tank, how much liquid nitrogen was lost and how long the samples were exposed to warmer temperatures, Baird said.

“There are so many variables … Until you know these things, you’re not going to know how the samples are,” he said.

Once samples are thawed and put under the microscope, though, it becomes very clear if they are viable, Baird said. They will appear dark and compressed and look very different than viable ones. 

HOW IVF GIVES HOPE

Whitacre and his fellow embryologists know the freezer tanks they oversee represent future children to couples and individuals undergoing in vitro fertilization in hopes of building families.

“What we do is amazing, to help people have kids,” Whitacre said. 

In vitro fertilization is a series of procedures used to treat infertility. Mature eggs are harvested from a woman’s ovaries and combined with sperm in a lab. The fertilized egg, or embryo, is implanted in the woman’s uterus.

The procedure can be done with a couple’s eggs and sperm, or genetic material from donors. Usually, multiple eggs are harvested – not all will mature into embryos — and more than one embryo is implanted in the uterus to increase the chances of pregnancy.

During each cycle of IVF, the woman receives drugs that stimulate her ovaries to produce more eggs than normal. Embryos that are not implanted are frozen for future rounds of IVF; one round costs about $12,000.

Some UH patients may not be able to try fertility treatments again, due to their age, medical conditions, inability to afford the cost or unwillingness to go through the time-consuming and exhausting procedure again.

Whitacre spends his time looking at egg cells under a microscope in Fertility Unlimited’s embryology lab, where eggs grow in a tabletop incubator a little smaller than microwave. He can see changes in eggs growing in Petri dishes just 16 to 18 hours after fertilization.

Advances in the techniques used to freeze embryos have increased the number that can be successfully thawed. Eggs are now allowed to develop for five or six days after fertilization before being frozen, Whitacre said. At this point, eggs are called blastocysts and they contain between 60 to 100 cells.

Water in the blastocysts cells is replaced with a cryoprotectant, which functions like antifreeze. Whitacre draws a single embryo into a narrow plastic straw, seals it and plunges it into liquid nitrogen. Each straw is labeled with its own number and the patient’s name. 

Under this technique, the pregnancy rates for frozen embryos is just as good as IVF with fresh embryos, Whitacre said.

Fertility Unlimited’s cryogenic unit can hold up to 1,000 embryos. Reproductive Diagnostics, which runs a national sperm bank out of Columbus, stores about 2,000 eggs, embryos and sperm in its lab.

Historically, frozen eggs were extras left over from fresh transfer. Now, fertility doctors realize that the drugs used to stimulate egg production also makes the uterine lining less receptive to allowing the embryo to implant. Freezing eggs allows time for the woman’s uterus to become receptive again before implantation. Freezing also allows time for genetic testing of embryos. 

Whitacre, and others who work in IVF, are aware of the tiny miracles they help create every day.

More stories about the UH freezer accident:

UH fertility clinic’s incident: What we know, what we still don’t

 

Have you been affected by the recent University Hospitals fertility freezer incident?

 

Cleveland couple double victims of UH fertility clinic malfunctions, lawsuit claims

Dozens of lawsuits expected in UH fertility clinic malfunction, lawyers say

 
 

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