by Dr. Jay S. Nemiro
"The recent birth of octuplets in Los Angeles has generated a media frenzy in the United States and around the world. Although we marvel at the live birth of eight babies, and give recognition to medical science and our colleagues who ensured their healthy delivery, this event has created a firestorm of controversy: How did this happen, especially with in vitro fertilization, when the number of embryos transferred is controllable? How did a woman who already has six children, is single, is a student living with her parents, and receives state disability payments undergo In-Vitro Fertilization (IVF)? How did the physician who provided care make his decisions? What is the standard of care? Who is going to pay for this? How can this be avoided in the future? Fertility physicians everywhere share all these concerns and are asking for action".
OctoMom and the birth of her octuplets was a disaster, a real failure of In-Vitro Fertilization (IVF) technology. It should have never happened. But the "story" started almost 30 years ago with the birth of the first In-Vitro Fertilization (IVF) baby in England in 1978. Although many marveled at the new and amazing technology, early success rates with In-Vitro Fertilization (IVF) were poor at around 5+%, on a good day. Over the next two decades or so, the field witnessed, not only a prolific growth in the number of In-Vitro Fertilization (IVF) clinics around the country, but the obvious and ever-present media attention to the growing number of multiples and, particularly, high-order multiples of 4, 5, and 6+. Our society got so desensitized to hearing about another set of high-order multiples that were born, that we created a reality show and watched it religiously. "Jon and Kate plus 8" should have never happened and it was a growing sign of our society's complacency and ignorance of multiple births. Yearly statistics started showing a significant statistical increase in the number of twins, triplets, quadruplets, and higher-order multiples being born at an alarming rate.
This happened for two reasons. First, there were 380 clinics in the United States by the end of 2000. Second, although In-Vitro Fertilization (IVF) success rates were improving from those early years, clinics had gotten used to putting back a lot of embryos, not necessarily to have better statistics than their neighboring clinics, as many outsiders accused us of, but in an attempt to make sure that the couple was successful and, in many cases, to honor their wishes of putting more back, again, in the hope that they would be successful and not have to do this "god awful procedure' again. For the most part, when a couple was successful, they only had one or two babies at the most, but occasionally that would backfire and the couple ended up with high-order multiples.
With a woman having trouble getting pregnant, known as "infertility", or when multiple women can not get pregnant over multiple cycles, which is due to some environmental issue like blocked tubes or a low sperm count ; on the other hand, the new word is "fecundity". This is the ability of a single woman to get pregnant on a single cycle and is related to her reproductive genetics. Is she "reproductively young or reproductively old"? Without knowing this, there would be no way to know if a woman that you transferred 4 embryos would have one baby, 4 babies, or no babies. With almost 400 clinics thinking the same way, not only did the incidence of multiples increase significantly, because any given woman's fecundity was unknown, but it was causing more and more public awareness and concern, raising health costs, more premature births, and the many associated problems and complications with prematurity.
Finally, the government got involved and told our Society, "either you solve this problem or we will". Having the government involved in any health care, let alone threatening to regulate our industry, would be a disaster and a grave disservice to our patients and would set In-Vitro Fertilization (IVF) technology back twenty years. As a result, our Society, after carefully evaluating the success and statistics of In-Vitro Fertilization (IVF) over the previous 20+ years, came up with guidelines based on sound scientific and clinical evidence regarding the number of embryos to transfer and were first published in 1998 and revised downward in 1999, 2004, 2006, 2008 and more recently in 2009 as the efficacy of In-Vitro Fertilization (IVF) improved. By the beginning of 2006, almost all clinics in the country were following these guidelines and over the next 2-3 years the incidence of multiple births dropped significantly. If you think about it, other than the birth of the octuplets, you have not heard much in the news about multiple births.
Although Arizona Center for Fertility Studies has had its fair share of multiples in the past, since following the guidelines, our incidence of multiples has significantly dropped and no one over the age of 35 has gotten fraternal triplets. Also, pregnancy rates have continued to improve as well, an initial concern that Arizona Center for Fertility Studies had if fewer embryos were transferred. Identical twinning occurs in 1 out of 250 pregnancies and cannot be controlled. However, many women, even older women who are not really at much risk, still talk about their fear of having multiples. Arizona Center for Fertility Studies thinks this is due to just not understanding the reasons multiples occurred in the first place and the lingering conditioning from the media. The truth is, with the current practices, the risk of having high-order multiples is extremely unlikely and women can be reassured that they will only have one or occasionally two babies, depending on their age. With our success rates being so good, Arizona Center for Fertility Studies will not be talked into going outside the guidelines unless there is a legitimate and medical reason to do so; and even then we will only put one more embryo back.
"Our Society and its members long have been concerned about problems created by multiple births, including the best interests of the children born. The guidelines published in 1998 and afterward clearly show the success of professional self-regulation. National data on in-vitro fertilization using fresh non-donor egg cycles show:
The recommended number of fresh embryos to transfer in a patient younger than 35 years old with a good prognosis (i.e. good embryo quality and no history of repeated prior failures of In-Vitro Fertilization (IVF) treatment, or chromosomal rearrangement) is one or at the most two. Owing to the lower chances of frozen embryos implanting, an additional embryo often is added in frozen embryo transfer cycles. Guidelines allow flexibility among In-Vitro Fertilization (IVF) clinics and patients depending on other prognostic factors to allow for individualized patient care.
Some have called for more regulation of In-Vitro Fertilization (IVF). Yet In-Vitro Fertilization (IVF) is already one of the most carefully regulated, accredited, and audited areas of medicine. Regulation, like in England, where only one embryo can be transferred, would be a disaster and a grave disservice to our patients and would set In-Vitro Fertilization (IVF) in the US back twenty years.
SART sets rigorous personnel and procedural standards. The Fertility Clinic Success Rate and Certification Act of 1992 requires annual reporting of pregnancy and live birth rates to the Centers for Disease Control and Prevention (CDC), the College of American Pathologists and ASRM, as well as to The Joint Commission accredit embryology laboratories which require on-site inspections every 2 years, and to the Food and Drug Administration which regulates many aspects of gamete and embryo donation. These guidelines, standards, licenses, and regulations have been successful in improving the success, health, and safety of women undergoing In-Vitro Fertilization (IVF) treatments and their resultant newborns. It should be noted that strict reproductive technology regulations in other countries have not been a panacea and are almost always associated with state coverage of the cost of assisted reproductive technology treatment. Those regulations sometimes have resulted in reduced pregnancy rates and denial of treatment to many women based on demographic factors and have promoted cross-border reproductive care. A recent news story in the BBC (England) stated, that less than 20% of women get to do In-Vitro Fertilization (IVF) three times. This is significant because even though the government pays for In-Vitro Fertilization (IVF), the law states that only one embryo can be transferred, thus resulting in much lower pregnancy rates per transfer. However, in the United States, private reproductive and parenting decisions never have been regulated, and this includes the decision parents and their physicians make regarding the number of embryos to transfer in In-Vitro Fertilization (IVF). Although some have suggested regulation in response to this extremely rare birth of octuplets, such action would ignore the success of professional standards and self-regulation, not only in this area of medicine but also in many others. Such action would be particularly troubling in reproductive medicine, where issues of personal choice and reproductive rights should be protected for everyone, and not just for infertility patients. Furthermore, no regulation will completely prevent substandard, immoral, illegal, or unethical behavior on the part of physicians or patients. Social justice requires a response to this event. ASRM and SART have called for a comprehensive evaluation of the medical practice in question and the physician and clinic involved was expelled from our Society.
The Society for Assisted Reproductive Technology also is reevaluating its guidelines regarding the number of embryos to transfer based on the most recent clinical data submitted by SART programs and is making its internal quality assurance and validation policies and procedures more stringent. We also call for more support for research in In-Vitro Fertilization (IVF) and for better insurance coverage for infertility care to help reduce patient motivation to transfer too many embryos. Physicians' compliance with practice standards could be helped by legal protection from unreasonable patient requests. The Medical Board of California, as well as those of other states, has the right to levy sanctions, including loss of medical licensure, for care that does not follow national standards.
In summary, this tragic situation has focused our attention on the problem of multiple births from In-Vitro Fertilization (IVF). ASRM, SART and their members have made much progress with this issue. Application of currently available regulations, guidelines, and professional organization procedures will protect the health, safety, and rights of women, children, and our society. The Society for Assisted Reproductive Technology and ASRM, as well as other stakeholders in reproductive medicine, are actively evaluating changes in the current system that can be made to reduce the risk further and hopefully prevent another tragedy in the future".
*** Parts of this section were reprinted from an editorial by David Adamson, M.D. and Elizabeth Ginsburg, M.D. from ACOG, Volume 113, No. 5, May 2009, pages 970-971.