Frozen ART

freezinga

Thirty minutes ago at Boston In Vitro Fertilization clinic in Waltham, eight cultured human embryos started the dehydration phase in preparation for freezing and storage. A cryobiologist slowly injected chemical cryoprotectant into the cells — replacing the cell’s water with propanediol — with a micro-pipette into labeled five centimeter-long plastic vials.

She then placed the vials into a humming, cold vapor-filled white canister. Dropping two degrees per minute, the machine automatically cooled the embryos from room temperature at 22 degrees Celsius to negative 7 degrees.

At this crucial step called “seeding,” technicians tapped the side of the vial, causing the cryoprotectant to freeze the embryo in an orderly crystal structure. After two gradual temperature shifts down to negative 150 degrees, the embryo vials, safely snapped onto thin metal canes, finally plunge into a chilling negative 196 degree storage tank of liquid nitrogen.

Looking down into the freezing steam of 30 cell-filled canes, a person might wonder, what’s the destiny of all these embryos?

With an estimated 500,000 frozen embryos already stored in IVF clinics throughout the country, the problem of what to do with them is increasing. Legal and ethical problems have genetic parents and IVF clinics looking for options for where to turn with unused embryos. And, private groups uncomfortable with the growing number of frozen embryos, offer adoption as an idea for uncertain couples.

Under current U.S. law, potential parents have the options to donate their embryos to research or other couples, discard their embryos or keep them in frozen storage indefinitely.

In the 1970’s, the establishment of in vitro fertilization clinics offered infertile couples a way to conceive children. Using a method called Assisted Reproductive Technology (ART), technicians combined eggs and sperm in a Petri dish to create human embryos.

IVF clinics routinely created extra embryos for patients because implantation into a woman’s uterus did not always produce a baby (as remains the case today). Although embryos became the legal property of the genetic parents, all extra embryos were considered biomedical waste and discarded.

This is, until 1983, when experiments by Trounson and Mohr proved successful pregnancy was possible from human embryos previously frozen in liquid nitrogen. The industry of frozen embryo storage was born soon after. Since then, the number of embryos in storage has skyrocketed as parents have chosen to keep rather than dispose of their embryos.

Today, with the advent of cryopreservation, IVF clinics must have legal agreement by the genetic parents to discard unused embryos. Patients sign detailed consent forms for each step of the in vitro fertilization process — including the freezing, storing, and thawing of embryos. Here, they acknowledge they understand the potential financial and technical risks of IVF, and decide the future of any extra embryos.

Some consent forms allow clinics to dispose of embryos after a certain time period if genetic parents cannot be contacted. More often, however, clinics consider these embryos forgotten, and keep them in storage.

Clinics, like Boston IVF, store frozen embryos in 50 pound wheeled cylinder tanks filled with liquid nitrogen. Embryos must remain at a steady temperature, and an alarm sounds if nitrogen levels drop inside the tank. Following general procedure, labs freeze embryos on day one, three, or five of development, and can store them for an unlimited length of time.

It is unclear, however, how long embryos stay viable for successful pregnancy, and clinics usually request that patients take or use their embryos within three to five years.

The growing number of stored embryos creates the possibility of many new babies being born, but it also carries many problems. Legal, ethical, and political battles sparked by emotional distress have many genetic parents uncertain about their decision, and religious groups voicing their concerns.

Opinions Vary

While parents look for solutions for what to do with their unused embryos, some religious organizations stand ethically opposed to the whole IVF process. Frozen embryo storage affects these people’s lives as a moral issue.

From a scientific standpoint, embryos are seen as cells with the potential for human life, but pro-life groups define embryos as living persons, and see disposing of embryos as murder.

“Embryos are seen as commodities, not gifts or blessings,” said Erik Whittington, American Life League executive director of youth outreach. “I worry about [those parents’] souls…their children in a storage facility.” Whittington suggests limiting IVF by creating only one “child” at a time.

While the idea may intrigue some, IVF specialists say that fertility treatment can only be successful using multiple embryos due to normally high rates of cell abnormalities.

Concerned about the fate of frozen embryos, one pro-life group offers couples a different alternative to IVF clinics. In 1997, the California non-profit group Nightlight Christian Adoptions founded Snowflakes, the nation’s first frozen embryo adoption program, which matches donated embryos with prospective parents.

The program gives the biological parents the option to set criteria for who can receive their donated embryos. In 2000 and 2004, under the Bush Administration, Nightlight Christian Adoptions received combined education grants of nearly $1 million from the National Institutes of Health to promote awareness through informational videos for medical professionals and advertising.

Nightlight Adoptions work with any hospital or clinic that couples want to use, however problems still exist. “Some [clinics] don’t want to work with [us] because they are only willing to transfer a certain grade quality of embryos,” said former Snowflakes program director, Lori Maze. She explained that Snowflakes takes any embryos for adoption. IVF clinics do not use old embryos because there is high risk they will die or become malformed during development.

Hospitals working with Snowflakes adoptions follow the same procedures as IVF clinics to implant embryos, but the program states an added benefit — new embryo parents may have contact with the genetic donor family because they are not anonymous like at IVF clinics.

Since 1998, Snowflakes has had around 200 successful births. And, couples pay around $10,000 to adopt embryos — a cost similar to Nightlight’s regular domestic adoptions program.

Yet, for many parents struggling with the emotional choice of giving away their embryos, the benefits of embryo adoption are not convincing. A 2003 survey conducted by the American Society for Reproductive Medicine found that most couples choose not to give away their embryos to others because they are uncomfortable with the idea of others raising their genetic children. Stated in another way, these couples form an emotional bond to their embryo.

Legal Aspects

In the absence of US federal laws, the issue of frozen embryo storage plays out in state courts. Notably, cases often involve divorced genetic parents who disagree on the destiny of their frozen embryo. For example, in 1992 the Tennessee Supreme Court heard Davis verses Davis, one of the first major cases involving frozen embryo storage, in which the mother, Mary Sue Davis, was granted the right to give birth to preexisting embryos, despite the father’s opposition.

In 1999, a similar case, AZ verses BZ, heard in the Massachusetts Suffolk County Probate and Family Court ruled in favor of the father, stating that, despite the evidence of seven signed IVF consent forms, people cannot be forced to become parents.

Today, state laws differ over the issue of frozen embryo storage. More conservative laws, such as in Louisiana, recognize embryos as juridical persons, rather than focus on the parents’ right to choose what will be done with their embryos. In other states, judges decide cases based on whether or how clinic consent forms should be enforced, or by balancing the harms for each potential parent.

In the Suffolk case, lawyer Gretchen Van Ness argued that this was the last chance for her 44 year old client to give birth. “The court said [the consent forms] were valid contracts,” said Van Ness. “They should uphold private decisions [like these].”

stem cell culture

Another layer of the issue is what terminology is used to describe frozen embryos. According to a 2009 analysis in the University of San Francisco Law Review by technical editor, Jennifer Baker, using the term ‘adoption’ vs. ‘donation’ to describe the handling of embryos holds inherent legal implications in how embryos are viewed, and that pro-life groups use the wordage ‘embryo adoption’ to further their political agenda to eliminate abortion rights.

Baker writes,“…the obvious interchangeability of “adoption” and “donation” in the IVF context demonstrates that Snowflakes is merely an extension of the war on abortion that was first waged in the courtroom and that is now carried out in the far more hospitable realm of assisted reproductive technology.”

IVF clinics largely self-regulate for all procedures, including frozen embryo storage, and government agencies only oversee and inspect operations. Clinics register with the FDA and Centers for Disease Control, and may choose to follow voluntary guidelines set by the American Society for Reproductive Medicine.

“[Clinics] are inspected and regulated by medical boards…for example, the American Association of Tissue Banks,” explained Boston IVF’s former scientific director, Doug Powers. If clinics choose not to follow industry standards, they can create their own, as long as procedural changes are reported to the FDA.

FDA regulated private storage companies could be another option for couples with extra embryos. Primarily a sperm bank, the Massachusetts-based company, New England Cryogenics started frozen embryo storage in the mid-80s, and is well-established among fertility clinics for sperm storage. Today, they credit business growth for frozen embryo storage to increased skill among doctors for freezing embryos, doctors’ referrals, and more knowledge available on the Internet.

Circulation of campus flyers also help to inform college women about frozen storage if they should want to donate embryos, just like for men who wish to donate sperm. Nationwide the cost of embryo storage varies, but patients can pay as much as $300 per year.

Donating frozen embryos to stem cell research also gives couples a place to take extra embryos. And, with President Obama’s pro-stem cell policies, the legal hurdles may now be fewer. Since the 2001 restriction on federal money for embryonic stem cell research, only relatively few privately funded labs, such as Harvard’s Melton facility in Cambridge, could use donated embryos.

Today, both the number of labs able to use stem cells, and parents’ desire to donate embryos to science are on the rise. “We have patients asking and wanting to donate to stem cell research…,” said Katharine Jackson, technical director for assisted reproduction at Brigham & Women’s Hospital in Boston.

So, while the destiny of every frozen embryo remains uncertain, genetic parents might find reassurance that more options are becoming available for storage or use of their frozen embryos. And, it seems these choices will not be limited by federal regulations anytime soon.