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Transparency in Fertility Clinic Reporting
Decreased Transparency in ART Reporting
Healthcare reporting in Assisted Reproductive Technology (ART) seemingly provides transparency by publishing in vitro fertilization (IVF) success rates reported by fertility clinics in the U.S. The Society for Assisted Reproductive Technology (SART) along with the Centers for Disease Control and Prevention (CDC) publish fertility clinic success rates annually. But a recent study indicated that there is decreased transparency in ART reporting. An increasing number of IVF cycles are excluded from the SART report annually, leading to reported improved clinical outcomes and as a result, increased market share for 13 U.S. fertility clinics.
The study, “The status of public reporting of clinical outcomes in assisted reproductive technology,” published in Fertility and Sterility in September 2013, and led by Dr. Vitaly A. Kushnir, analyzed fertility clinic data that was reported to both the CDC and SART for the years 2005 to 2010. It details that initiated IVF cycles – cycles that were started, but did not result in embryo transfer - were excluded from final outcome reporting. SART allows exclusion of cycles if they are designated as experimental or have no immediate expected cycle outcomes: frozen donor cycles, social egg freezing cycles, fertility preservation, egg thaw embryo transfers and cycles where all embryos were frozen due to PGD or for embryo banking.
According to the report, the number of excluded cycles increased steadily to more than 7% of IVF cycles in 2010. By 2010, 13 fertility clinics (identified in the report as “outliers”) accounted for 50% of the cycles that were excluded from that year’s SART data. “These 13 clinics reported significantly better pregnancy and cancellation rates than national averages, and collectively increased their share of U.S. ART cycles by 19.9%,” the report says.
Dr.Kushnir explains the criteria for identifying the outliers. All fertility clinics were plotted on a bell curve and the outliers were labeled arbitrarily as the top 5% of clinics with excluded cycles. “The outliers we happened to focus on were selected purely on a statistical basis as the ones who are doing the most of this compared to 95 percent of the other clinics.”
According to the study, “embryo banking” – where a cycle is started, but does not have a clear outcome because all embryos are frozen - is likely the primary clinical practice that has led to the excluded cycles.
“We don’t know if these clinics did anything wrong or right,” says Kushnir. “They are reporting in the current mechanism as they should. Just because they’re doing a lot of embryo banking, that’s their clinical practice, they could have ended up as one of the top outlier clinics. The goal here was to point out there was major loophole in the system that allows some clinics to slip through. And whether they’re doing this intentionally or they’re doing everything correct in the framework and still benefitting from it, we don’t know.”
But the fact remains that results of the increase in embryo banking has inflated the IVF success rates of the 13 fertility clinics. According to the report the data shows that “outlier clinics initiated IVF cycles in disproportionately large numbers of older women who never advanced to embryo transfer and therefore went unreported,” and, “Older women have lower pregnancy rates, therefore outcome data skews favorably for clinics excluding older women and less favorable patients from fresh cycle outcome reporting.”
“What’s happening is some of the outlier centers are taking women who are poor prognosis, either because they have poor ovarian reserve, or because they have failed prior IVF attempts elsewhere or because they produce few embryos or for a variety of other reasons or because they are undergoing PGS. And they’re disproportionately directing these patients that have a low pregnancy chance to begin with towards embryo banking. In other words, they’re not transferring the embryos in their IVF cycle. Instead they are freezing all their embryos and then transferring them in a later frozen embryo transfer cycle,” Kushnir says. “Only the good prognosis patients reached embryo transfer, then all the poor prognosis patients got excluded. It’s a classic patient selection. Poor prognosis patients are being directed towards embryo banking. Whereas good prognosis patients are allowed to have an embryo transfer so that inflates the clinic’s fresh rates also inflates their frozen rates as we point out, and it decreases their cycle cancellation rates because instead of cancelling them, they’re just directing them to embryo banking [so they’re not reported, rather than reported as cancelled],” he continues.
However, Kusnir adds there can be clinical justification and medical indication for freeze all cycles.
Dr. Said T. Daneshmand, a reproductive endocrinologist with The Fertility Center of Las Vegas, has published the only two randomized prospective controlled trials that showed that frozen embryo transfer was more superior to fresh. “One of the things that is now completely apparent is that frozen cycles have a higher rate of pregnancy than fresh cycles in all age groups except women under 35,” he says. The byproduct of the ovarian stimulation – the hormones that the ovaries produced, including estrogen, testosterone and progesterone - can have a negative impact on the receptivity of the uterus, Daneshmand explains. “What ovarian stimulation in essence does, it shortens the window of implantation, where the embryo has a chance to attach and grow into a pregnancy. If you have fast growing embryos, you’re okay with fresh embryo transfer, because your embryos are going to make it within that window of implantation. If the embryos grow a little bit slower, the pregnancy rate is reduced significantly because the embryo is going to miss that window of implantation. If it’s not fast growing, a little slower or average, the embryos have a disadvantage. It may be a perfectly healthy and normal embryo but it’s not going to attach and grow into a pregnancy.”
Success Rates Not Reflective of Current Practice
“We’re not saying otherwise,” Kushnir says. What we’re saying is that there has been an exponential increase in these freeze all cycles in the last couple of years. The current reporting system has not reflected this change in practice. What’s driving this change in practice is unclear, as our report points out. Is this purely being driven by a change in practice or is there a financial incentive for clinics to practice in a certain way that’s being created by the reporting system? That’s the heart of our article: Does transparency lead physicians to treat patients in a different way than they otherwise would? That’s the question we’re proposing here and it’s open for debate,” Kushnir adds.
There is a financial incentive for fertility clinics in this scenario. “The clinics that are doing disproportionate amount of embryo freezing are showing higher pregnancy rates and ultimately increase their market share of ART cycles in the country,” Kushnir says. “Whether you’re doing that through data manipulation or because you have an excellent lab, those are two different things. What we’re saying here is that since the market share increased there is definitely an incentive for people to practice this way.”
“The issue and the quote lack of transparency that was described, is well known and it has related to what I would say are our common sense handling of what initially was fertility preservation cycles. If a clinic was treating a patient that had newly diagnosed breast cancer and wanted to preserve embryos for the future prior to undergoing chemotherapy, we didn’t want to penalize the clinic for treating that patient and having it count as a cycle start at their clinic summary report,” says Dr. Kevin Doody, SART Registry Chair and reproductive endocrinologist with the Center for Assisted Reproduction in Texas. But as has been pointed out, many more cycles wound up not included in the ART reports.
According to Doody, the SART reporting will change to reflect current clinical practices and more importantly to correctly reflect success rates. The summary report traditionally has labeled IVF outcomes as fresh and frozen, and the labels for the 2014 report will change to primary and secondary, he says.
“The first embryo transfer following the cycle start for stimulation and egg retrieval will be reported as an outcome whether or not it happens fresh, or simply the initial thaw following that cycle. Fertility preservation cycles will remain excluded. We will report out all cycles with the intent of transferring the embryos within 12 months of cycle start, as an IVF cycle.” Doody says. For example if a clinic does three stimulations for embryo banking and you do one embryo transfer with one embryo from each of those three, and the patient has a live birth, the pregnancy rate for that cycle is one out of three. If there is no live birth, the outcome rate will we zero out of three.
The 2014 reporting, which will be published in 2016, will reflect these changes, which Doody believes will satisfactorily address the lack of transparency. “This is something that has been recognized as an issue in SART and we’ve been working on this. This is my fourth year on the registry committee, second year as chair, and this is something that’s been on the front burner the whole time frame,” he says.
Dr. Daniel Shapiro, a reproductive endocrinologist with Reproductive Biology Associates in Atlanta, isn’t happy with the current reporting system or the proposed changes. Thousands of egg freezing cycles are unreported, and Shapiro’s fertility clinic does a significant number of egg freezing cycles with My Egg Bank, a frozen donor egg program. He explains that every donor stimulation cycle is considered a cycle start, but because it’s not linked to a transfer it isn’t listed in the report. Egg thaws are also reported as initiated cycles but aren’t listed in the donor section of the report either. It’s misleading, Shapiro contends. Even with the 2014 reporting changes, there is still no way to account for egg banking, and people will underestimate the quality of programs that have large egg banks. “The problem is practices that are clever about registering cycles for freeze all in autologous cycles opposed to egg bank cycles, are benefitting from what ultimately gets reported in their age-related tabs,” he says.
Using Data to Compare Fertility Clinics
While fertility clinic success rate data can be helpful by giving a patient a general idea of what other patients in their age range have achieved, it doesn’t provide information about specific cases or which fertility clinic is right for you
The data should not be used to compare clinics to each other, most will agree. “Inevitably patients do,” Kushnir says. Additionally, “Government agencies are subsidizing clinics based on their success rates. It’s important to realize that transparency has all these effects, and as healthcare moves more and more towards reporting outcomes, there may be a lot of unanticipated effects. And those who get affected the most by this are poor prognosis patients because they’re denied the care they should have.”
“Because now more than ever the clinic summary report should not be compared between clinics, we’re shortly changing how we handle people trying to look at data [on the SART website],” Doody says. Currently the SART website has a very small disclaimer below the clinic reports. Going forward a dialogue box explaining that clinical practices can prevent any fair comparison between clinics will appear over grayed out data.
But will these changes be enough? Kushnir’s study states that, “Future reports should become more patient centered, so that the total reproductive potential per initiated ART cycle, including initial fresh and subsequent frozen embryo cycles, can be assessed as a measure of ART success. Ideally cycle reporting by clinics should be prospective in nature to document the intended treatment plan of each initiated cycle from the start. ART reports should incorporate perinatal outcomes in the definition of ART success to reflect the main goal of every ART cycle, the birth of a healthy baby to a healthy mother.”
According to a recent online survey by FertilityAuthority of 111 fertility patients, the most important factor in choosing a fertility clinic is fertility clinic success rates. Unless the lack of transparency is addressed, and reporting protocols become clearer, patients may be misled into thinking clinic success rates will mean success for them.