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IVF - Why ACFS has chosen not to continue its participation in SART

The Fertility Center Success Rate Reporting Act (FCSRRA) was first enacted in 1992.

SART (Society of Assisted Reproductive Technology), a group within the American Society of Reproductive Medicine (ASRM), was initially formed to report clinic specific data for IVF in an organized format for patients to evaluate before choosing to go to an individual clinic for IVF. Arizona Center for Fertility Studies was one of the first clinics to join SART and honorably, accurately and without any bias, reported their IVF data to SART for the next 22 years.

SART was always clear that couples should not compare data from different clinics because there were so many factors that are considered in a clinic’s selection and/or reporting of their data. Knowing that the SART data would be available to all patients, there were clinics that “top-loaded” their data by only doing patients that had a “good prognosis” of success. Also, if patients were “not stimulating well” the cycle was cancelled and thus would not count against their data. Additionally, there were some clinics that did not do an embryo transfer if the embryo(s) did “not look good and/or were behind developmentally” with the recommendation to discard; again, not “taking a hit” in their statistics. Some clinics had an age restriction (because older patients had a decreased success rates) and donor eggs was “jammed down their throats” as their only choice.

Fortunately, most clinics, including ACFS, did not “play these games” and did not “select” their patients and never discriminated on who they did IVF on and never turned down a patient for fear she “would affect their statistics”. On the contrary, ACFS welcomed all patients, regardless of “their odds”, age or egg numbers; and whose only chance of having a baby was by doing IVF.

The Fertility Center Success Rates Reporting Act, first enacted in 1992, has undergone multiple revisions to the original legislation:

  • 08/26/1997
  • 09/03/1999
  • 09/01/2001
  • 02/05/2004
  • 02/01/2005

SART’s job was to report clinic specific data in a consistent format (that changed and evolved over the years). SART also initiated “spot-checking” of individual clinics data to “check” if their data was “suspicious” and/or “higher than the national average”. ACFS was also one of the first clinics “to be inspected” because our data was much higher than the national average. The inspectors randomly reviewed 50 charts over a given period of time. They found zero deficiencies and/or transgressions on how our data was reported. ACFS was never audited again, although your data continued to always be higher than the national average.

By 2002, SART announced that all clinic-specific monitoring and auditing would be discontinued. SART also announced that “spot-checking” clinics for compliance would also cease, and all reporting would be up to the “good will and integrity” of member clinics. In the last couple of years, SART has restarted the program of auditing and “spot-checking” approximately 10% of member clinics; as well as telling them “what and how” they could language information on their web site. When doing the audit, they would review 50 full IVF cycle records and 25 partial record cycles chosen at random. In addition, all live births were also confirmed by intruding upon the patient’s lives and calling them to verify that the clinic was “truthfully” reporting correct data and that an IVF cycle “had actually occurred” and that the “reported” live birth actually happened.

When ACFS had initially been audited years earlier, SART “made” us call 10 patients to “verify” that we were not “making up the data”. ACFS had not problem participating with the audit (and were honored that we were chosen for an audit based on our high success rates) but was infuriated with the “accusation” that we had fabricated our data; and even more upset that we had to call the couple, with the SART representative on the other line, listening to the call to confirm that indeed the couple “had a baby”. This is the extent of the oversight and review of reporting as it stands today. In addition to these intrusions, SART started charging member clinics for each IVF cycle they started. Remember, joining SART is voluntary.

Noteworthy, the actual legislation requires fertility clinics to report IVF data information to the CDC, not to SART. The CDC gathers this data for all fertility centers around the country via NASS (National ART Surveillance System), the only CDC-approved data reporting system for ART (Assisted Reproductive Technology). SART is only an approved “clearinghouse” for this data collection, which is then sent to the CDC. According to the Fertility Clinic Success Rate and Certification Act, all ART cycles performed in the United States fertility clinics are legally obligated to report to the CDC. Through their contract with WESTSTAT, INC., the CDC can directly collect IVF data, similar to what SART does; which ACFS feels it does in a more accurate and representative format of the data, than SART does. In addition, there are no charges for NASS (Weststat, Inc.).

There are some inherent flaws in even the current data collection models, which ACFS feels needs to be addressed, as they are vital to accurately representing a clinic’s success rates. The first and largest issue is the delay in reporting outcome information. Waiting for live birth information for an entire calendar year means that the data being viewed today is over two years old. There are few people today that would argue technology and medicine are growing by leaps and bounds with advances in treatments and understanding happening very rapidly. Clinicaltrials.gov lists over 163,000 current ongoing clinical trials. That means in the span of two years, over 300,000 clinical trials have taken place. Medline, which is the data house for the US National Library of Medicine adds 2,000-4,000 journal articles per day to their database, or over 700,000 journal articles per year.

So the question is: How well does the information gathered over two years ago reflect what is currently happening in your clinic of choice? How have advances in egg freezing, vitrification (cryopreservation) and PGD/PGS (pre-implantation diagnosis/pre-implantation screening) been reflected in the information you are reading today regarding a clinic’s successes? The answer is easy. The information regarding outcomes from both the CDC and SART publications are grossly inaccurate and not reflective of current technologies and advances in our field of reproductive medicine. There are currently no fields available in SART to report some of the current technologies being used on a daily basis, mainly the use of PGD/PGS and FET (frozen embryo transfer); leading to more inaccuracies in reporting. Some states have mandatory insurance coverage for IVF while some clinics accept insurance contracts; therefore, inevitably creating different patient populations and demographics and thus affecting IVF data outcome. For example, insurance companies in the State of Massachusetts (an insurance mandated state for infertility) allow 6 “covered” cycles of IVF; whereas in Arizona (a non-mandated infertility insurance state), very few insurance companies offer any coverage and patients have to pay “out of pocket”. As a result, if you live in Massachusetts you are more likely to do IVF much sooner and have “better candidates” and more often; thus improving your outcome. If you live in Arizona, you are less likely to do IVF and may go with it only as a “last resort”. Comparing any clinic based on published SART or CDC information is misleading and fundamentally inaccurate. SART has even acknowledged this very thing recently when Kevin Doody, the registry chair for SART on a Q & A session said: “Registry data is not appropriately used by patients to compare clinics directly. We will discourage this use as best we can, but realize that comparisons will be made”.

For almost the last 5 years, ACFS has realized that the key to improved IVF success is not to do a fresh transfer even at the blastocyst stage; but to do PGS (pre-implantation screening) with subsequent FET (frozen embryo transfer). SART does not have “categories” to actually represent this ground-breaking technology, whereas NASS does; and if a clinic is no longer not doing fresh transfers and only FETs (frozen embryo transfers), SART does not show the results of that data and subsequently the clinic’s results “appear” poor and grossly misrepresented; whereas, in reality, ACFS is having some of the highest success in the country.

For the above reasons and until there is a better system for reporting data in more real time, with more oversight and integrity, ACFS has decided to no longer report their IVF data to SART. As a result of this decision, ACFS data on the SART report will appear as “not reported”. ACFS will continue and honorably report their IVF data to the CDC as required by law but will not participate in reporting through the CDC “clearinghouse” SART but rather through CDC’s approved program- Weststat, Inc. where our data will be viewable at http://www.cdc.gov/art/index.html. We believe that SART has failed our field as advocates and voices for what ACFS is so passionate about. ACFS’s data (although two years in the rear) will still be available through the CDC site and will actually continue to represent the exciting success we are having with PGS and FET. The ACFS website will also show our current data and update patients on any “breakthroughs” it is making in reproductive medicine and continuing to “push to envelope” and “think out of the box” to continue to improve IVF success and pregnancy outcomes.

Of note, more and more clinics (currently a 20-25% of clinics in the US) are disillusioned with the way SART “does business” and are choosing to no longer be a member clinic of that society; and reporting their IVF data directly to NASS via Weststat, Inc.

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