CDC-reported assisted reproductive technology live-birth rates may mislead the public

CDC-reported assisted reproductive technology live-birth rates may mislead the public

ARTICLE IN PRESS Short communication CDC-reported assisted reproductive technology livebirth rates may mislead the public Vitaly A Kushnir a,b,c,*, ...

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ARTICLE IN PRESS

Short communication

CDC-reported assisted reproductive technology livebirth rates may mislead the public Vitaly A Kushnir a,b,c,*, Jennifer Choi a,c, Sarah K Darmon a, David F Albertini a,f, David H Barad a,d, Norbert Gleicher a,d,e,f a b c d e f

The Center for Human Reproduction, New York, NY, USA Wake Forest School of Medicine, Winston-Salem, NC, USA Wyckoff Heights Medical Center, New York, NY, USA Foundation for Reproductive Medicine, New York, NY, USA Department of Obstetrics and Gynecology, University of Vienna School of Medicine, Vienna, Austria The Rockefeller University, New York, NY, USA

Dr Kushnir is a Reproductive Endocrinology and Infertility physician. He serves as Director of Continuing Medical Education, Director of Fertility Preservation Centre and Associate Scientist at the Centre for Human Reproduction in New York, as well as Adjunct Assistant Professor of OBGYN at Wake Forest School of Medicine in Winston-Salem.

A B S T R A C T The Centre for Disease Control and Prevention (CDC) publicly reports assisted reproductive technology live-birth rates (LBR) for each US fertility clinic under legal mandate. The 2014 CDC report excluded 35,406 of 184,527 (19.2%) autologous assisted reproductive technology cycles that involved embryo or oocyte banking from LBR calculations. This study calculated 2014 total clinic LBR for all patients utilizing autologous oocytes two ways: including all initiated assisted reproductive technology cycles or excluding banking cycles, as done by the CDC. The main limitation of this analysis is the CDC report did not differentiate between cycles involving long-term banking of embryos or oocytes for fertility preservation from cycles involving shortterm embryo banking. Twenty-seven of 458 (6%) clinics reported over 40% of autologous cycles involved banking, collectively performing 12% of all US assisted reproductive technology cycles. LBR in these outlier clinics calculated by the CDC method, was higher than the other 94% of clinics (33.1% versus 31.1%). However, recalculated LBR including banking cycles in the outlier clinics was lower than the other 94% of clinics (15.5% versus 26.6%). LBR calculated by the two methods increasingly diverged based on proportion of banking cycles performed by each clinic reaching 4.5-fold, thereby, potentially misleading the public. © 2017 Reproductive Healthcare Ltd. Published by Elsevier Ltd. All rights reserved.

* Corresponding author. E-mail address: [email protected] (VA Kushnir). http://dx.doi.org/10.1016/j.rbmo.2017.05.008 1472-6483/© 2017 Reproductive Healthcare Ltd. Published by Elsevier Ltd. All rights reserved. Please cite this article in press as: Vitaly A. Kushnir, et al., CDC-reported assisted reproductive technology live-birth rates may mislead the public, Reproductive BioMedicine Online (2017), doi: 10.1016/j.rbmo.2017.05.008

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Introduction Based on the Fertility Clinic Success Rate and Certification Act of 1992 (FCSRCA), fertility clinics in the USA have to report annually assisted reproductive technology outcome data to the Centre for Disease Control and Prevention (CDC). This law defines success of assisted reproductive technology by live-births rates (LBR) per attempted ovarian stimulation, and tasks the CDC to annually report LBR for each clinic. The principal architect of FCSRCA, US Senator Ron Wyden has described this law as a public reporting model for other medical and surgical specialties (Adashi and Wyden, 2011). Rapidly increasing utilization of embryo-banking cycles, in which all embryos are cryopreserved and no fresh transfer occurs, have confounded the purpose of this reporting system since, in contradiction to the intent of the FCSRCA, such cycles are currently excluded by the CDC from calculations of LBR (Kissin et al., 2013; Kushnir et al., 2013). Excluding such cycles significantly inflates reported LBR by shrinking the denominator of initiated assisted reproductive technology cycles, which are a major burden and cost for patients. This is particularly true for poor prognosis patients who are preferentially directed to embryo banking (Kushnir et al., 2013). Assisted reproductive technology clinics which perform many embryo banking cycles, therefore, benefit from reporting inflated LBR (Kushnir et al., 2016). The objective of this analysis was to determine the degree by which assisted reproductive technology LBR are inflated in the CDC annual report based on proportion of embryo banking performed by each fertility clinic.

Materials and methods We re-analysed publicly accessible, aggregate fertility clinic data used to generate the CDC’s (2014 Assisted Reproductive Technology Fertility Clinic Success Rates Report). Total clinic LBR for all patients utilizing autologous oocytes in both fresh and frozen embryo cycles were calculated, as previously described, with reference to cycle initiation (Kushnir et al., 2016) in two ways: either, as intended by FCSRCA, including all initiated assisted reproductive technology cycles or, as currently practiced by the CDC, excluding banking cycles. The CDC currently records both oocyte and embryo banking as a single data point. Calculations were performed as follows: total number of autologous oocyte/embryo assisted reproductive technology cycles reported as banking cycles by the centre for all ages (delayed transfer and fertility preservation not distinguished) = A. Total fresh and frozen initiated autologous oocyte/embryo assisted reproductive technology cycles reported by the centre for all ages = B. Number of live births for fresh autologous cycles = percentage LBR per cycle for each age group × total number of cycles reported for that age group = C, Number of live births for thawed autologous cycles = percentage LBR per transfer for each age group × total number of transfers reported for that age group = D.

LBR FCSRCA = ((C + D) ( A + B)) × 100 LBR CDC = ((C + D) B) × 100 Percentage banking = ( A ( A + B)) × 100

LBR were then analysed by linear regression models. All analyses were performed using SAS version 9.4 (SAS Institute Inc., USA).

Results In 2014, 458 assisted reproductive technology clinics performed 184,527 autologous oocyte assisted reproductive technology cycles. Among those, 35,406 (19.2%) were categorized as banking cycles and, therefore, were excluded from CDC assisted reproductive technology LBR calculations. A total of 46,557 live births were reported, for a national LBR of 31.2% per CDC; but only of 25.2% per FCSRCA accounting for banking cycles. Figure 1 demonstrates that with increasing use of banking in individual assisted reproductive technology clinics, the LBR calculated by the CDC method increase, while accounting for banking per FCSRCA method, LBR substantially decrease. Out of 458 reporting assisted reproductive technology clinics, 27 (6%) clinics reported that over 40% of their autologous cycles involved banking (Supplementary Table S1). These clinics performed 12% of all autologous US assisted reproductive technology cycles; they also demonstrated the widest gaps in LBR between CDC and FCSRCA assessments, diverging by as much as 4.5-fold.

Discussion The presented findings demonstrate that, by statistically favouring assisted reproductive technology clinics that perform a high proportion of banking cycles, LBR for assisted reproductive technology cycles reported by the CDC are misleading. By excluding large numbers of banking cycles from consideration, these clinics present exaggerated LBR to the public but actually achieve lower LBR per initiated cycle than the national average. These observations are consistent with disproportionate use of embryo banking in poor prognosis patients (Kushnir et al., 2013, 2016) primarily for short-term accumulation of embryos (Doody, 2014), rather than genuine fertility preservation. Our findings are corroborated by a recent report examining the same issue on the parallel, voluntary assisted reproductive technology reporting system maintained by the Society for Reproductive Technology (SART) (Kulak et al., 2016). SART has recognized the issues posed by short-term accumulation of embryos and has recently made extensive changes to its reporting system to more accurately present the data in its reports (Doody, 2014, 2016). Because of the recent changes in calculating assisted reproductive technology LBR by SART, the public may now face varying outcome reports from two authoritative sources (CDC and SART). While the two organizations have different missions, presentation of divergent LBR to the public will create more confusion, thereby eroding trust in assisted reproductive technology treatment. Since prospective patients may use the CDC report to select assisted reproductive technology providers, exaggerated outcome reporting may be economically beneficial for a minority of assisted reproductive technology clinics. For a large majority of assisted reproductive technology clinics (94%) differences between LBR calculated per CDC or FCSRCA method are relatively small; however, in the 6% of clinics which perform extensive embryo banking reported LBR are greatly exaggerated. Current CDC reporting, therefore, incentivizes

Please cite this article in press as: Vitaly A. Kushnir, et al., CDC-reported assisted reproductive technology live-birth rates may mislead the public, Reproductive BioMedicine Online (2017), doi: 10.1016/j.rbmo.2017.05.008

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Figure 1 – Effect of banking cycles on 2014 assisted reproductive technology live-birth rates for 458 US assisted reproductive technology clinics. Each clinics’ live-birth rates (LBR) is represented by a red X and a blue O based on two methods of calculating LBR. The figure demonstrates that under the current CDC reporting system, which excludes banking from consideration, LBR increase with increasing utilization of banking by assisted reproductive technology clinics. In contrast, if banking cycles are considered according to the FCSRCA mandate, the figure demonstrates a decline in LBR with increasing utilization of banking. The consequence is up to a 4.5-fold difference between LBR calculated by these two methods in clinics with the most extensive utilization of banking. CDC = Centre for Disease Control and Prevention; FCSRCA = Fertility Clinic Success Rate and Certification Act of 1992. (For interpretation of the references to colour in this figure legend, the reader is referred to the web version of this article.)

embryo banking while unintentionally confusing the public about the true assisted reproductive technology LBR in these clinics. One potential limitation is that the CDC report does not allow differentiation between a minority of cycles which involved long-term banking of embryos or oocytes for fertility preservation from the majority of cycles which involved short-term embryo banking. This ambiguity further compounds the problem. The current CDC reporting system should be revised in accordance with the FCSRCA to present the public with accurate LBR data. Moreover, the CDC and SART should be encouraged to collaborate to ensure that their respective reports present complimentary rather than divergent data to the public. This analysis demonstrates that public reporting of healthcare outcomes should be performed with great caution and monitored for unintended consequences.

Declaration: V.A.K. previously served as a consultant to the CDC. The Centre for Human Reproduction (CHR) annually reports assisted reproduction technology outcome data to CDC. N.G., D.H.B. and V.A.K. are listed as coowners of a number of already awarded and still pending US patents, none related to the topic of this manuscript. N.G. is a shareholder in Fertility Nutraceuticals, LLC and owner of the CHR. N.G. and D.H.B. receive patent royalties from Fertility Nutraceuticals, LLC.

Keywords:

Appendix: Supplementary material

Assisted reproductive technology Health care outcomes

Supplementary data to this article can be found online at doi:10.1016/j.rbmo.2017.05.008. A R T I C L E

I N F O

Live-birth rates Public reporting

REFERENCES

Article history: Received 11 January 2017 Received in revised form 8 May 2017 Accepted 9 May 2017

Adashi, E.Y., Wyden, R., 2011. Public reporting of clinical outcomes of assisted reproductive technology programs: implications for other medical and surgical procedures. JAMA 306, 1135–1136.

Please cite this article in press as: Vitaly A. Kushnir, et al., CDC-reported assisted reproductive technology live-birth rates may mislead the public, Reproductive BioMedicine Online (2017), doi: 10.1016/j.rbmo.2017.05.008

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Doody, K.J., 2014. Cryopreservation and delayed embryo transferassisted reproductive technology registry and reporting implications. Fertil. Steril. 102, 27–31. Doody, K.J., 2016. Public reporting of assisted reproductive technology cycle outcomes is not simple. Fertil. Steril. 105, 893–894. Fertility Clinic Success Rate and Certification Act of 1992, HR 4773ENR, 102nd Cong (1991–1992). Pub L No. 102–493. Kissin, D.M., Crawford, S., Boulet, S.L., 2013. The status of public reporting of clinical outcomes in assisted reproductive technology. Fertil. Steril. 100, e16–e17.

Kulak, D., Jindal, S.K., Oh, C., Morelli, S.S., Kratka, S., McGovern, P.G., 2016. Reporting in vitro fertilization cycles to the Society for Assisted Reproductive Technology database: where have all the cycles gone? Fertil. Steril. 105, 927–931, e3. Kushnir, V.A., Vidali, A., Barad, D.H., Gleicher, N., 2013. The status of public reporting of clinical outcomes in assisted reproductive technology. Fertil. Steril. 100, 736–741. Kushnir, V.A., Barad, D.H., Albertini, D.F., Darmon, S.K., Gleicher, N., 2016. Effect of embryo banking on U.S. national assisted reproductive technology live birth rates. PLoS ONE 11, e0154620.

Please cite this article in press as: Vitaly A. Kushnir, et al., CDC-reported assisted reproductive technology live-birth rates may mislead the public, Reproductive BioMedicine Online (2017), doi: 10.1016/j.rbmo.2017.05.008