IVF ‘Add-On’ Procedures Offer False Hope
New research suggests that costly extra services lack evidence that they work
When Pamela Mahoney Tsigdinos and her husband were trying to conceive with in vitro fertilization (IVF), they were presented with many “add-on” procedures that they were told would increase their chances of a successful pregnancy. “We were relying on the physicians to give us the information and guide us,” she says.
After several years, three IVF cycles, and $50,000 later, Tsigdinos and her husband were still unable to conceive. “Most women don’t talk about it because it’s traumatizing,” says Tsigdinos, author of Silent Sorority.
Couples often pay a premium price in hopes of conceiving a child. A single cycle of IVF can be $12,000. And the costs don’t end there. Couples at fertility clinics are frequently offered pricey “add-on” services touted as ways to increase the chances of IVF success.
However, two new studies published Tuesday in the journal Fertility and Sterility suggest that there’s very little evidence (and in some cases, no evidence) to support the use of these add-ons, including procedures like immune therapies and endometrial scratching. Not only do they not increase a woman’s likelihood of conceiving and giving birth, but some add-on procedures may also even cause harm to women, eggs, and embryos.
What’s more, some add-ons may even reduce the chance of a live birth. Take an embryo screening method called preimplantation genetic testing for aneuploidy (PGT-A), which costs around $5,000: Screened embryos that have abnormalities are routinely discarded, but new data from a large 2018 study found that some abnormality discoveries do not actually impact the embryo’s success. “We now know that those embryos were probably fine, and a lot of those embryos that we would have previously thrown away, now we transfer them and they turn them into babies,” says study author Jack Wilkinson, a lead researcher at the Centre for Biostatistics at the University of Manchester who has a PhD in measuring outcomes in IVF.
Most of the IVF add-ons routinely made IVF more complicated and increased the cost without any clear benefits.
Wilkinson and his fellow researchers — including Tsigdinos — found that the lack of add-on regulation in the IVF industry means such procedures are introduced into routine practice before they’ve been shown to increase the success rate of live births. Federal authorities do not need proof that these procedures provide a benefit for patients. Fertility clinics are required to report their success rates to the U.S. Centers for Disease Control and Prevention (CDC), but other than that, there are no other reporting requirements. In determining success rates, some fertility clinics focus on the number of pregnancies they’ve achieved rather than the number of live births. “This is coupled with extensive and persuasive marketing that is sometimes misleading about one’s chances of taking home a baby,” says human biotechnology policy advocate Marcy Darnovsky. “Many have called the U.S. fertility industry a Wild West.”
Mohan Kamath, a professor of reproductive medicine at Christian Medical College in India and a lead researcher on a second paper published in Fertility and Sterility, reviewed the quality of data on IVF add-ons and found a lack of rigor. “The internet is flooded with so much information about IVF treatment, it may be difficult to figure out which one is working and which one is not,” he says.
In line with the other research team, his review found that most of the IVF add-ons routinely made IVF more complicated and increased the cost without any clear benefits or evidence to support their use.
Endometrial scratching, for example, is a commonly offered add-on that entails inserting a catheter through the cervix and into the uterus where it’s used to scratch and inflame the uterine lining. The goal is to make embryo implantation easier. Yet in a randomized trial of 1,364 women, the procedure was found to provide no increase in live birth rates. “Most of these IVF add-ons should be viewed with a certain amount of skepticism,” says Kamath.
Some countries cover IVF as part of publicly provided health care, and countries like Canada and Australia do not allow clinics to be paid for expenses beyond the standard IVF process. “Fertility treatment in the U.S. is not covered by public or most private insurance,” says Darnovsky. “Instead, it is a lucrative private, for-profit enterprise.”
Without any independent oversight, the researchers behind the new studies argue that the IVF industry in the U.S. will continue its trajectory as a multibillion-dollar business at the expense of hopeful couples. Most argue that clinics need to share the risks and accurate success data with prospective patients. While many clinics do not claim that the add-ons will definitely lead to a live birth, many people pay for add-on procedures with the assumption that they may help.
“I do think it’s going to be really important for both legislators, state and federal, to look closely at an industry that’s approaching $36 billion without any accountability and oversight,” says Tsigdinos. “When you ask the industry to police itself, they don’t.”