More American children conceived through in vitro fertilization were born in 2013 than ever before, an estimated 1.5% of all births, according to data from the Centres for Disease Control and Prevention. And most of those procedures were done with little oversight.
The number of IVF cycles done in the United States increased by 28% from 2003 to 2012, and that rising trend has spiked in recent years. Based on preliminary data, the number of IVF cycles increased by 21% in just one year, from 2012 to 2013.
IVF is a procedure in which eggs are taken from a woman’s ovaries and fertilised with sperm in a petri dish. Then one or more fertilised embryos are placed in the woman’s uterus, where one will hopefully implant and grow into a baby.
The CDC collects and publishes data about IVF, as required by the Fertility Clinic Success Rate and Certification Act passed in 1992, but not all clinics report their data to the CDC, only limited data about IVF outcomes are reported, and there are no official guidelines limiting which procedures can be done.
This level of government oversight leaves the industry to regulate itself for the most part, deciding on its own what procedures are appropriate to perform for patients.
What self-regulation looks like
The professional organisations for fertility clinics and doctors, the Society for Assisted Reproductive Technology (SART) and the American Society for Reproductive Medicine (ASRM), are the closest thing the field has to regulators.
Every clinic that performs IVF is invited to belong to SART, Dr. Pasquale Patrizio of the Yale School of Medicine’s fertility center told Business Insider. Over 90% of fertility clinics are members, according to the organisation’s website. To remain in good standing with SART, clinics must report data about the procedures they do and follow the recommendations it issues.
SART collects information about why patients sought infertility treatments, whether the eggs or embryos used in IVF were donated or frozen, whether certain procedures were used beyond traditional IVF (like intracytoplasmic sperm injection, when scientists insert sperm into an egg to fertilize it instead of mixing them in a petri dish), how many embryos were transferred per IVF cycle, the percentage of cycles that resulted in pregnancies and live births, and the percentage of births that were twins or multiples.
SART makes this data from individual clinics available online, along with national averages.
Practice committees for the ASRM and SART write reports and opinions on various aspects of assisted reproduction, like what new procedures, treatments, or knowledge are emerging and when they should be applied.
For example, the practice committees have recommendations in place for how many embryos should be transferred per cycle depending on the age of the woman doing IVF, based on their own collected data and other scientific publications.
Doctors, however, are not obliged to follow these recommendations. New procedures do not have to be approved before they can be performed in clinics.
For clinics that belong to SART, “somebody is watching over your shoulder,” Patrizio told Business Insider. Plus, labs that deal with human eggs, sperm, and embryos are subject to Food and Drug Administration oversight, like other labs that work with human tissue — but only in that they must comply with measures to prevent the spread of disease.
To that end, the FDA requires prospective egg and sperm donors to be tested for HIV, Hepatitis B and C, chlamydia, and gonorrhea, and for stored embryos, eggs, and sperm to be labelled so they don’t get mixed up. The FDA has the power to inspect and shut down labs if they don’t meet the legal requirements. As with other areas of medicine, the agency regulates the drugs and devices used in assisted reproduction treatments, but not the actual procedures clinics do.
Clinics do have incentive to provide quality service to patients and stay in good standing with SART to maintain their reputations and avoid malpractice suits, but doing anything the organisation recommends is completely voluntary. If clinics don’t comply with SART guidelines about procedures, they receive a letter from the organisation, Patrizio said.
How we got here
The reason the US doesn’t have government oversight of the assisted reproduction industry like the UK does is because of our history, George Annas, a bioethicist and health lawyer at Boston University and author of “Genomic Messages,” told Business Insider.
Historically, it’s been illegal for the National Institutes of Health to fund research on human embryos. (A ban in place since the late 1990s has softened somewhat under the Obama Administration.) Without government money for research, IVF was developed in private clinics where the focus was on providing services to patients, not doing research first.
Now the industry decides itself what new procedures can be done on patients, which is “pretty unique,” according to Annas.
“It’s pretty loose out there,” he said.
Where that leaves us
So what does this mean for the thousands who get assisted reproduction treatments in the US every year?
It means that fertility clinics can offer treatments to patients for purposes that ASRM and SART have not approved, with no clear repercussions.
For an example, look no further than elective egg freezing. The ASRM and SART practice committees only announced egg freezing isn’t an experimental procedure anymore in 2013, and they still don’t recommend it for women who are healthy and fertile but want to delay having kids until they might have more difficulty getting pregnant. They only recommend egg freezing for women who face the prospect of infertility because they need chemotherapy or another essential treatment that damages the ovaries.
But that published guideline isn’t stopping clinics from offering the procedure to women on an elective basis, and they were doing so even before the experimental label was lifted, Miriam Zoll, whose memoir “Cracked Open: Liberty, Fertility, and the Pursuit of High-Tech Babies” is about her experience trying to conceive through assisted reproduction, told Business Insider.
“To only have the industry monitoring itself is not necessarily proving to be the best case scenario for the health of women and children,” she said.
It’s good that the assisted fertility industry does have some oversight and guidance from professional organisations, with leeway for doctors to make decisions based on the particular needs of individual patients, but there are significant questions about whether that some is enough.