Thursday, November 6, 2014

IS FREEZING YOUR EGGS DANGEROUS? A PRIMER





When news broke several weeks ago that tech giants Apple and Facebook were offering female employees elective egg freezing benefits, much of the commentary criticized the decision, interpreting it as a message to women that they should postpone motherhood in favor of advancing their careers—or perhaps their company’s bottom line. Few articles, however, addressed the fact that experts do not view this as a procedure that should be encouraged.

The American College of Obstetricians and Gynecologists (ACOG) does not endorse egg freezing for the “sole purpose of circumventing reproductive aging in healthy women.” Two years ago, the American Society for Reproductive Medicine (ASRM), a membership organization representing roughly 500 fertility clinics in the U.S., lifted the “experimental” label from the procedure, but stressed that its decision was not an endorsement for healthy women to freeze their eggs for future use.

After reviewing 981 fairly small studies, of which only 112 addressed safety and efficacy concerns, ASRM’s practice committee wrote: “While a careful review of the literature indicates egg freezing is a valid technique for young women for whom it is medically indicated, we cannot at this time endorse its widespread elective use to delay childbearing.” Citing the critical lack of medical evidence and potential emotional risks the committee cautioned: “Marketing this technology for the purpose of deferring childbearing may give women false hope.”

Prior to these recommendations, a 2010 study reported that of 442 fertility clinics surveyed, 283 were already providing expensive “experimental” freezing services: one-third offered it to women with cancer, while two-thirds offered it “electively to women of advancing maternal age.” It is not clear how many of these clinics were providing these services under an experimental protocol overseen by an Institutional Review Board, as was recommended by ASRM at that time. Today, far more clinics are disregarding ASRM’s most recent guidelines and offering elective egg freezing as a top-tier item on their menu of services.

This eagerness to push forward with non-medically necessary egg freezing services raises an important question: How safe and effective does a technology like this need to be before it is sold to young, fertile women?  

How Did Egg Freezing Arise?

Oocyte cryopreservation—the technical name for egg freezing—is a young and tenuous science. While frozen sperm and embryos have routinely been used in reproductive medicine since the 1950s and ’60s, egg freezing has only been used since 1986 and is more technically complicated. Human eggs contain a lot of water, and during the freezing process ice crystals can rupture the egg’s delicate structure and disrupt the chromosomes inside it.

Only recently has a new flash-freezing technique known as vitrification improved “freeze-thaw” rates to a point where between 90 to 97 percent of eggs survive. Far fewer, however, result in the birth of a baby following in vitro fertilization (IVF) procedures. The Society for Assisted Reproductive Technology reports that only 2 to 12 percent of thawed eggs lead to a live birth in women age 38, and the most comprehensive study to date suggests live birth failure rates as high as 76 percent in women age 30 who attempted more than one cycle with thawed eggs.  In women age 40, the rates of failure are 91 percent and higher.

Is Egg Freezing Safe?

Egg freezing isn’t the first innovation to shift from being a strictly medical treatment—primarily for cancer patients—to an elective or “enhancement” procedure. Cosmetic surgery developed out of treatments for wounded soldiers, and drugs approved for conditions like narcolepsy, ADHD, and heart failure, are today being used to improve human performance. But as the debate over these so-called “enhancement therapies” has shown, making the leap from medical intervention to elective procedure is tricky. For one thing, healthy end users generally have less to gain and more to lose.

Like those who sell their eggs or undergo IVF, women using egg freezing services must submit to ovarian hyper stimulation and egg retrieval procedures. Both techniques carry risks, but with no mandatory national U.S. registry tracking the health of patients or consumers undergoing these procedures, it is impossible to know exactly how many women actually experience problems. One voluntary data-collection effort is the Infertility Family Research Registry, housed at Dartmouth-Hitchcock Medical Center. Unfortunately, fewer than 100 of the 500 infertility clinics in the country actively encourage patients or consumers to join and share their health experiences, or those of their offspring.

So how does the process actually work? Drugs known as gonadotropins are used to hyperstimulate women’s egg production from one or two eggs (during a normal monthly cycle) to upwards of a dozen or more. During egg retrieval, a surgeon, guided by ultrasound technology, pushes a long needle through the vaginal wall and into the ovary. Once the needle punctures the ovary, it is maneuvered to pierce one follicle after another, and suction is then applied to draw the follicular fluid into a test tube. Floating within the fluids are the oocytes—the eggs.

There are many safety concerns:  potential pelvic and abdominal pain, injury to the bladder, bowels or blood vessels, pelvic infection, and damage to the ovaries that are punctured during retrieval. Doctors treating egg donors, in particular, have been known to hyperstimulate their patients to the point where many routinely generate 30 or 40 eggs, and sometimes even more. Some donors have reported becoming infertile or experiencing early menopause after exposure to the drugs or retrievals that can leave behind damaging scar tissue. In other instances, their ovaries have swelled from the size of walnuts to that of grapefruits, indicating a not-so-rare condition known as Ovarian Hyper Stimulation Syndrome (OHSS). 

Depending on the woman and the drug dosages, mild OHSS can manifest as bloating and abdominal pain that goes away on its own, but sometimes symptoms are more serious. Severe cases of OHSS may require hospitalization for bleeding, severe fluid buildup and pain in the abdomen and lung area, difficulty breathing, decreased blood flow to the kidneys due to blood thickening, and in the most critical cases, even stroke or death. Patient follow-up studies from Canada indicate that about one-third of women who undergo ovarian stimulation suffer “mild” OHSS. In a British study tracking 339 women, roughly 14 percent were hospitalized for OHSS after stimulation cycles yielded more than 20 eggs. 

Though most babies born through freezing methods that also required IVF appear to be healthy, more long-term data on developmental outcomes is needed before safety can be adequately and responsibly evaluated in children. There is not enough medical evidence to know whether the liquid nitrogen and other chemicals used in the new flash freezing technique are toxic to embryos and how they affect cell development.

The most recent national summary available from the Centers for Disease Control and Prevention indicates that 46.4 percent of all babies born through assisted reproductive technologies (ART) were high-risk twins, triplet or higher order births, and costs for their care far exceeded earlier estimates of one billion dollars annually. Though often underreported in the media, additional risks linked to children born through ART include higher instances of preterm birth, low birth weight, stillbirth, neurological impairments like cerebral palsy, and increased associated risks of up to 28 percent of certain birth anomalies, especially of the eyes, neck, heart, and urogenital tract.

Despite All This, Egg Freezing Is Being Aggressively Marketed

Healthy and presumably fertile women in the U.S. are being told that egg freezing is as revolutionary and liberating as the Pill. The most dramatic campaigns have come from egg freezing brokers—businesses that act in partnership with drug companies and fertility clinics. An especially egregious example is EggBanxx, which hosts “Let’s Chill” egg freezing cocktail parties, several sponsored by the drug company EMD Serono, Freedom Fertility Pharmacy, and three New York City-based ASRM member clinics.

The invitation for its September 2014 event at a posh Manhattan hotel highlighted the “Three F’s: Fun, Fertility and Freeze.” Guests who attended told us that EggBanxx presenters did not discuss high failure rates or alarming gaps in safety studies, but they did pitch financing options and offered $500 and $1000 discounts through follow up emails several days later. With a perpetual media and marketing blitz, and clinic websites touting slogans like “set your own biological clock” and “take control of the calendar,” many healthy young women might think they are being negligent if they don’t sign up to “insure” their chances to become a mother in the future.

This kind of dreaming and imagining is lucrative. Egg freezing service providers charge anywhere from $7,500 to $10,000 for one freeze cycle—and upwards of $30K for the three cycles they recommend to find that “one good egg.” Tabulate additional cash-layouts for annual storage fees ($500-$1000), drugs per cycle ($2,500 - $7K) and later, at least one but likely multiple IVF cycles minus the egg retrieval ($12K per cycle), and you’ve conservatively topped out at an estimated $45K—with no guarantee that a healthy baby will be born.

Weighing the Bioethical Risks

Women facing the specter of chemotherapy and radiotherapy know that their fertility will be seriously compromised, if not destroyed. In these patients, the argument can be made that egg freezing is safe enough and effective enough to be a reasonable option. Indeed, this is what ASRM’s and ACOG’s practice committees concluded. Yet these same committees determined that existing research did not adequately meet the medical or safety standards needed to endorse egg freezing in the general population.

Unlike cancer patients, healthy, young women don’t face an immediate and unavoidable threat to their fertility. The threat they do face—time—is certainly real, and can feel overwhelming. But egg freezing, and all the risks it entails, may not be the most effective way to respond to the ticking of the biological clock. If women rely on this technique and it fails years later, they may have lost their reproductive window of opportunity forever. From this vantage point, healthy young women have more to lose than cancer patients.

Commercial interests are erroneously marketing egg freezing as an “insurance plan for motherhood.” Like IVF, egg freezing is more like a gamble or a wager than insurance. “You put down $15,000 or $30,000 dollars and you might be able to preserve your fertility,” says Karen Maschke, a political scientist and research scholar at the Hastings Center, “but there are no guarantees.”

Why Informed Consent is Crucial—But Not Enough

There is no question that women who choose to freeze their eggs are legally entitled to balanced and comprehensive information about the medical, ethical, and psychological risks and concerns associated with egg freezing—including what is not yet known about its safety and efficacy. 

But informed consent alone—which is often surprisingly difficult to obtain—cannot resolve the ethics of elective egg freezing. As scholars in bioethics have argued, an overreliance on informed consent can blind us to the cultural, economic, and political contexts that often pressure patients and customers into believing that they have little choice but to agree to medical interventions that do not necessarily meet their needs or align with their values.

We must ask why women who want to have children fear that, for professional or personal reasons, they will be unable to do so during their safest and most fertile years. If we fail to ask that question, we inevitably endorse a world in which the very real forces that create this fear and reality are not held to account. In this world, “responsible” women freeze their eggs, and the complicated societal problem of reconciling work and family is theirs alone to resolve.  

Josephine Johnston is the director of research and a research scholar at the Hastings Center, a bioethics and policy institute in New York. Miriam Zoll is the author of Cracked Open: Liberty, Fertility and the Pursuit of High-Tech Babies (2013) and a member of the board of the women’s health organization, Our Bodies Ourselves.
By Josephine Johnston and Miriam Zoll Photo: Shutterstock.com
http://www.newrepublic.com/article/120077/dangers-and-realities-egg-freezing

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