Lauren Citro, 32, has been trying to conceive for nearly six years.
She’s received fertility treatments at four clinics in three states.
In her effort to exhaust all options, she’s sampled almost every intervention recommended: immunology testing, assisted hatching, supplements, acupuncture, intracytoplasmic sperm injection, testicular sperm extraction and the list goes on.
She trusted her doctors—and didn’t want to drive herself crazy Googling things when fertility treatment is already a high-stress process—but the info she received from providers tended to be minimal and conflicting. Case in point: She went through what’s known as an endometrial scratch that was described as “highly recommended” at her third clinic, only to find out it was entirely dismissed at a fourth place, because of the trauma it causes.
So Citro finally started doing some sleuthing online. Now, she asks a lot more questions. And as time goes on, and the more she hunts for evidence, the less she’s willing to try different options. “Our rationale used to be ‘can’t hurt, might help,’ ” Citro, a nurse in San Diego, says of the additional treatments she and her husband had during six IVF retrievals and four transfers (total cost: more than $100,000). “But that’s not necessarily the case.” (She points to another example: a $7,000 testicular extraction of sperm that the results said had “no impact on our outcome.”)
About 10 percent of women in the U.S. struggle to conceive or stay pregnant, and nearly 2 percent of all births in the country are via in vitro fertilization (IVF), which costs upwards of $15,000. But beyond that, more than two-thirds of fertility clinic patients spend up to $10,000 per cycle on so-called “optional extras” or “add-ons”—emerging techniques a clinic might offer on top of mainstream fertility treatment (i.e., IVF), supposedly to improve the odds even further and typically (almost always) for an additional cost. Add-ons, like the ones Citro tried, are rarely covered by insurance—though, in general, getting any part of your fertility treatment covered is still not the norm.
Many health-care providers are becoming increasingly worried that fertility extras come with costs far beyond monetary ones. Out of a group of routinely offered add-ons, 26 of 27 lacked rigorous, conclusive research to back their effectiveness for improving pregnancy or birth rates, found a recent investigation conducted by Oxford University and published in the British Medical Journal. Plus, the research ID’d at least one of the procedures (preimplantation genetic screening, which we’ll get to later) as potentially harmful.
“On some level, fertility treatment is like going to a Chinese restaurant and picking items from a dim sum cart, and it shouldn’t be that way,” says Rachel Ashby, MD, an ob-gyn at Brigham and Women’s Hospital Center for Infertility and Reproductive Surgery and an instructor at Harvard Medical School.
Piling on to the controversy is the fact that some experts believe there are flaws in the way U.S. fertility clinics are overseen. The U.S. requires fertility centers to report the basic details of each treatment cycle—outcomes, infertility diagnosis, number of embryos transferred, use of fresh or frozen embryos, donor or non-donor eggs—to the Centers for Disease Control and Prevention (CDC) each year.
So in that sense, the industry is highly regulated. While that sounds like a positive fact, there is no penalty if a clinic doesn’t report to the CDC; it’s simply listed as “non-reporting.”
The American Society for Reproductive Medicine (ASRM) also offers practice guidelines and opinions on how clinics should operate, including whether certain add-ons should be used on all patients, but businesses are not required to follow these either.
Many experts in the field say that for a lot of interventions, the science isn’t there yet. That doesn’t mean it will never advance, or that add-ons unanimously deserve a shady rap. But until we know whether an add-on works for a certain patient group—and whether the potential benefit outweighs the risk—some believe they should be offered sparingly, with the science (and its flaws) and the pros and cons laid out clearly and deliberately for every single patient. Unfortunately, that doesn’t always happen.
Whew, that’s a lot to unpack. The data is messy and unfinished. Clinic regulation is loose. Yet women remain hopeful. And how could they not when faced with the opportunity to do everything in their power to start a family? WH goes deep…
Extra helpful—or just plain harmful?
The debate is a minefield, starting with the word add-on itself. These treatments are generally unproven, yes. Still, many healthcare providers and patients are so insistent about the value that they bristle at the mere suggestion that add-ons are frivolous.
Deborah Anderson-Bialis, a founder of FertilityIQ, a website that provides independent analysis of clinics and doctors, points out that proponents would much prefer the phrase options for treatment to add-ons, because the latter has a negative connotation and implies they’re unnecessary. Some medical publications use the term adjuvants instead of add-ons.
This year, the United Kingdom’s fertility regulatory agency began rating nearly a dozen add-ons with a traffic light system, with green reserved for procedures shown to be effective and safe by at least one good-quality randomized clinical trial (the gold standard of research). Not one has received a green rating yet. And if you’re wondering, the U.S. has far less regulation than the U.K., which may stem from Congress’s 1996 ban on the use of federal funds for research related to the creation of embryos.
Here’s a snapshot of the points of contention:
The most commonly advocated add-on in recent years is preimplantation genetic testing for an abnormality called aneuploidy, or PGT-A. It’s also one of the most expensive ($3,000 to $8,000, depending on where you live). Some practices, particularly in competitive markets like New York, recommend it (and sometimes insist on it) for 100 percent of patients, according to Norbert Gleicher, MD, founder of New York’s Center for Human Reproduction. But there is so far no evidence that it increases live birth rates, which is why insurance doesn’t cover it. The U.K.’s watchdog group has given the screening a red-light rating, as it risks damaging fragile embryos by removing cells to test for these abnormalities. Meanwhile, an ASRM committee analyzed the available studies and concluded there was “insufficient evidence to recommend the routine use.”
But this is where things start to get complicated—like, really complicated. Proponents of PGT-A will point out that there’s a potential upside with PGT-A in women who have miscarried (aneuploidy is thought to be the biggest cause of miscarriages). And while PGT-A did not improve the live birth rate in all subjects, women over 38 who had PGT-A screening were found to have a better chance of achieving a live birth and were significantly less likely to have a miscarriage, possibly because they avoid being implanted with an embryo that’s genetically abnormal from the get-go, found a study in Human Reproduction. This may be reason enough for some women to choose it. That all being said, the study authors note that it remains to be seen whether the benefits outweigh the drawbacks of cost and invasiveness.
“This is a tool we can use to lessen our patients’ suffering and also give them some peace of mind that the pregnancy that’s created is genetically normal,” argues Catha Fischer, MD, an ob-gyn at Reproductive Medicine Associates of New Jersey. Two sides to every coin, in a sense.
Intracytoplasmic sperm injection (ICSI) is a common add-on.
This is when the single best-looking sperm (and it definitely is a beauty contest; it’s done by sight) is picked to be injected into the egg. (In conventional IVF, the egg is put in a petri dish with a bunch of sperm, and whichever one gets to it first is the winner.) For people who have no evidence of male-factor infertility, which is at least 50 percent of patients, the chances of getting pregnant are identical whether you pay the $1,000 to $2,500 for ICSI or not. Yet ICSI is being offered to people who aren’t, as doctors say, medically indicated for the issue. In fact, 66 percent of IVF cycles used ICSI—and only 32 percent actually had male-factor infertility alone—per the latest CDC report.
What’s more, the British fertility regulatory authority warned that ICSI has slightly more risk than other fertility treatments; eggs may be damaged when they’re cleaned and injected with sperm. ICSI may also be associated with genetic and developmental disorders, though it’s not clear whether this is connected to the treatment itself or the infertility that prompted its use.
Reproductive immunology is another extra offered to many women.
The add-on is so controversial that it has prompted experts to stand up and scream at each other at otherwise staid medical conferences, which Anderson-Bialis has witnessed. The method uses drugs to suppress the mother’s immune system, based on the theory that her immune system goes out of control and mistakenly targets her pregnancy, possibly causing infertility, failed IVF, or miscarriage.
A little perspective here: Those are just a few examples of hot-button add-ons—from a list of nearly 30. And not every supplemental fertility tool has such clear potential downsides. Most others just don’t have verified positives…and cost a lot.
The “yes” mentality, explained
The fact that patients are embracing add-ons makes total sense: You’re determined to grow your family, and the fertility window is cracked open only so long, right? It can feel as if there simply isn’t time to wait for conclusive research. And given the incredible expenses of fertility treatment, many women prefer to walk away knowing they gave it their absolute best shot.
“We spent a lot of money because we wanted to feel like we did everything we could,” says Citro, who notes that for months after her last cycle, it was difficult to talk about her long quest for parenthood without crying. “It’s an emotional roller coaster.”
In these situations, many people are understandably searching for a sense of control, says psychologist Jessica Zucker, PhD, who specializes in women’s reproductive and maternal mental health. “When your body isn’t doing what you wanted or expected it to do, all sorts of feelings can result from this—disappointment most especially. But you have ownership over what you’re willing to go through to try to conceive. So it’s a good idea to get familiar with your limits.”
These extras also glitter with a success halo. It’s tempting to revel in positive stories in online communities and message boards and read into the content. But, says Dr. Ashby, “anecdotes are two steps below voodoo in terms of value.” There are more than 200—you read that right—variables that can impact an IVF cycle, according to Mandy Katz-Jaffe, PhD, scientific director of the fertility clinic network CCRM. So it’s not possible to pinpoint one single variable as responsible for the birth of a healthy baby.
However, when you’re struggling with infertility, there’s power and comfort in believing. Maybe I’ll be the one person in 1,000 it works for, you imagine. Katie Coester, 37, of Washington, D.C., went to a clinic that “didn’t try to upsell,” as she describes, and recommended only two add-ons: testing embryos for chromosome abnormality and endometrial scratching. (Her IVF was covered by insurance; the additions cost her some $2,000.) She also scoured message boards for possible ways to increase her odds, which is how she ended up doing acupuncture, watching funny movies (a small study done in Israel recommended laughter), and eating, er, pineapple core.
Coester had only one fallopian tube and was 31 when she started treatment. She had fairly quick success—but if she hadn’t, she thinks she would have paid for anything and everything. “You think, I’ve come this far,” says Coester, who is now a mother of two. “Even with insurance coverage, we had to say, ‘How far are we willing to push my body? What is the emotional toll we’re willing to take?’”
Balancing data with dreams
This brings us to the line the medical world is currently struggling to straddle: finding middle ground between forgoing ineffective and costly treatments and offering patients potentially helpful ones that just may not have a large randomized controlled trial behind them, says Zev Williams, MD, PhD, chief of reproductive endocrinology and infertility at the Columbia University Fertility Center.
“There is a mistaken notion that medical treatments are either futile or backed by large, well-controlled randomized studies,” says Dr. Williams. “The reality is much more nuanced than that—there is a large area in the middle where there is either preliminary or limited data showing benefit.”
Karina Shreffler, PhD, a professor of human development and family science at Oklahoma State University, says the super-solid research studies are extremely expensive and difficult to secure funding for and also complicated to run. You need a large enough sample of diverse women receiving a specific kind of treatment (and a control group of similar women who don’t receive the treatment). Even then, she says, you’d be working within the challenge that only some women seek fertility treatment, and that they’re different from the women who don’t (due to lack of finances, ethical reasons, and geography). So that poses additional considerations when it comes to interpreting the results.
Until the science catches up (if it does, that is), the Big Question remains: Why do clinics offer these treatments in infantile stages? First, many interventions in medicine—new cancer treatments, for instance—are instituted before there’s a ton of research if there is even a slight inkling that they may help. Or, sadly, the more cynical take: Offering add-ons gives clinics a financial edge, many experts suggest. Because so few insurance companies pay for PGT-A, for example, private clinics and labs get the full fee, as opposed to insurance companies’ lower reimbursement rates, making the procedure a moneymaker for the fertility industry. “These things are highly profitable,” says Arthur Caplan, PhD, founding director of NYU Langone’s Division of Medical Ethics. “It’s ‘We have desperate people here, and we can sell them anything.’”
Focusing on a fertile future
If you’re in the market for treatment, the bottom-line advice is to hitch your wagon to a health-care professional who is willing to take the time to educate you—and to know you. “If you meet with a doctor, and all you’re getting is ‘this is what you should do,’ then you need to find a new one,” says Dr. Ashby. A praiseworthy provider will help you analyze and interpret conflicting fertility data—which is tough to do as a layperson—and will also draw from their experience treating patients with cases similar to yours. (Dr. Fischer likes to tell patients, “If you’re thinking about Googling a question, just email me instead. I can shield you from worrying over misinformation or a misunderstanding.”)
Grappling with infertility can suck the life out of you. But in the end, the best you can do is try to make an informed decision.
With all the new fertility and egg-freezing pop-ups, it’s critical to consider quality and experience over flashy marketing and trinkets. A doctor’s goal, always, should be “to give every patient the very best chance of success and to practice patient-focused and evidence-based care, while also being transparent about the data behind medical recommendations,” says Dr. Williams. More safeguarding suggestions: Consider a facility that is attached to a university, and seek out multiple opinions before green-lighting a procedure for yourself.
Citro, for one, needs a break from it all—the doctors, the studies, the clinics, the add-ons, the Googling. She hit pause for now but has not lost hope. After nearly six years of letting infertility dominate her life, she and her husband took a break from IVF—and a vacation to Europe. “We know we’ll go back to treatment eventually,” she says. “We really hope that we end up with kids. Whatever happens, I want to look back and know that I made the very best decisions for me.”
How to Prep for the Unknown
Grappling with infertility can suck the life out of you. But in the end, the best you can do is try to make an informed decision. Go in with an investment plan of sorts (in your mind or on paper) that details what you’re comfortable putting into the process monetarily and emotionally. “Brainstorm in advance what you’re willing to devote to this—the money, the energy, the time off from work if you need, perhaps—and what you’re not,” says psychologist Jessica Zucker, PhD. Maintain flexibility. It’s okay if your expectations and limitations evolve or change over time. “Try not to judge yourself at any stage of the process,” she stresses. In the end, you got this, no matter what that means for you.