GUEST BLOG POST: Consent to Freeze: Reading the IVF Fine Print by Carolyn Savage, author, Inconceivable

Our names will be forever connected with one of the most significant medical errors ever made inside a fertility clinic. In February 2009, through a process referred to as a frozen embryo transfer, another couple's embryos were mistakenly transferred into my body. Eight months later, I gave birth to a baby boy who we relinquished to his genetic parents a few minutes after delivery. Following the pregnancy, it became important to us that this mistake never happen again. Through research and asking questions of fertility specialists, our list of concerns has grown past the obvious need to make sure proper patient safety protocols are in place, to include even graver concerns with regards to how human embryos are handled. Who is making decisions about which embryos are transferred, cryopreserved, and discarded?

We thought we had control regarding how our embryos were handled. Turns out, we were wrong.

As part of the investigation into how the wrong embryos were transferred into me, we requested my medical records. While reviewing the documentation from our first in vitro fertilization in August 2006, we were saddened to learn that three of our embryos were handled in a manner that conflicted with our personal beliefs, which we thought we had clarified when Sean and I signed a Consent to Freeze form provided by our clinic. This form directed the clinic to cryopreserve any unused, viable embryos following my embryo transfer. The morning of my original IVF transfer, we had five viable embryos that had developed to the blastocyst/morula stage. We chose to transfer two. What we didn't know was that our three unused embryos were going to be held out of cryopreservation for two additional days, in an attempt to see if they eventually met the clinic's unique quality standards that determine which embryos are frozen. Sean and I assumed that if they were alive the day of transfer, they would be frozen following our transfer. We had no idea that behind the scenes, in a lab that we had no access to, our three embryos were going to be measured against a standard that had never been explained to us.

Consent to Freeze forms are signed by patients every day inside fertility clinics across the world. Yet embryos that qualify for cryopreservation in one clinic may not qualify for cryopreservation by the standards of another. There is no industry wide standard for grading the quality of human embryos. Clinics determine which grading scales they use and set their own unique criteria to freeze. We have even learned of instances where doctors within the same clinic use different criteria to determine embryonic viability.

The truth is that no embryo grading scale can determine, with certainty, which embryos will turn into healthy babies. High-grade embryos often fail to yield pregnancies and poor grade embryos are capable of producing perfectly healthy babies. Logan Morell, the little boy I gave birth to as a result of the mistaken transfer, was born from an embryo that was given a poor quality grade. We have learned through research that many fertility doctors would have canceled my frozen embryo transfer because Logan's embryo wasn't good enough. Thank goodness our doctor left that decision to us. We believe the choice of whether to transfer or not, whether to freeze or not, belongs to the patient.

Do fertility doctors play God during the IVF process? When they take decisions about the fate of human embryos out of the hands of patients, we believe they do. Sean and I admit we made an incorrect assumption about the meaning of a Consent to Freeze form. We didn't know to ask about our clinic's criteria. We didn't think to give specific instructions to freeze our unused embryos immediately following my transfer regardless of their quality ratings. These are mistakes that we have to live with, and it's tough. All three of those embryos had higher quality ratings than Logan's embryo. We'll never know if they might have become a child.

Sean and I believe decisions regarding medical treatments should always be between a patient and the doctor. But with little regulation and almost no oversight in the fertility industry, it is imperative that patients educate themselves thoroughly about their clinic's procedures. Patients should ask for a copy of their fertility clinic's embryo grading system. In addition, the clinic should provide couples a detailed explanation of the criteria used to determine if an embryo is fit for transfer, or fit for cryopreservation. After reviewing these policies, patients must clearly communicate in writing their desires. For patients to make informed decisions, they should communicate daily with the clinic staff about embryonic development. If a doctor refuses these requests, find a new clinic!

We believe in vitro fertilization is God given technology, just like open heart surgery, chemotherapy, and antibiotics. We are also aware that the science of assisted reproductive medicine poses ethical questions that require serious thought. Many have condemned the medical treatments available to infertile couples because they believe it "interferes with nature" or "circumvents God's role in creation." Sean and I wholeheartedly disagree. IVF has helped us bring our daughter into the world, and we have no doubt that in time, she will positively impact the lives of the people around her. Regardless of one's opinion about assisted reproductive techniques, it is in the best interests of fertility professionals and patients that protocols ensure patient safety; that communications about human embryos are clear and concise; and that there is complete transparency in the process of assisted reproductive techniques.

© 2011 Carolyn Savage, author of Inconceivable: A Medical Mistake, the Baby We Couldn't Keep, and Our Choice to Deliver the Ultimate Gift
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Sean and Carolyn Savage's, story was covered widely when they gave birth to the baby boy in September 2009, including People magazine and on The Today Show. In Inconceivable: A Medical Mistake, the Baby We Couldn't Keep, and Our Choice to Deliver the Ultimate Gift, they are telling the entire story for the very first time. Sean and Carolyn live in Ohio with their two teenage sons and a two-year-old daughter.  For more information, visit http://inconceivablebook.com.