Increasing access to infertility care- What will it take? By all measures, there is a huge unmet need for individuals facing infertility around the world, particularly in lower and middle income countries (LMIC). While patients with infertility in many developed countries such as Western Europe and Australia struggle less in accessing infertility care, this is not the case in the United States. By most estimates, less than half of individuals and couples with infertility can access all the care available to them in the U.S. and many cannot access any care. Further, the National Survey of Family Growth (NSFG) reported in its last calculations that for women of childbearing years, use of infertility services has dropped 15% to 20% since 1995, depending on the population studied (1). The European Society of Human Reproduction and Embryology (ESHRE) calculated an assisted reproductive technology (ART) standard demand for services to be greater than or equal to 1,500 in vitro fertilization (IVF) cycles per 106 population/year (2, 3). The U.S. meets only 40% of this demand compared to Australia and Scandinavia who have met more than 100% of demand by this calculation. Finally, in 2013 it was calculated that 1.6% of total live births in the U.S. were attributable to ART compared to Sweden, Australia, and Denmark where 3.5%, 3.6%, and 5.9% of live births, respectively, are from IVF. The Society for Assisted Reproductive Technology Registry (SART CORS) data have consistently demonstrated that the U.S. leads worldwide in IVF success rates and that these success rates have improved every year since the first reports. Despite this, there remains a large proportion of infertile patients in the U.S. who cannot access infertility care. The American Society for Reproductive Medicine (ASRM) 2014–2019 Strategic Plan was entitled, ‘‘Global Impact through Dynamic Engagement.’’ Within that plan, the third of seven strategic goals is ‘‘Impacting Reproductive Care,’’ for which a major initiative has been devoted to Access to Care (ATC). From September 10–11, 2015, an Access to Care Summit was held in Washington, D.C. The ASRM assembled 75 thought leaders from across the U.S. and nearly a dozen countries who were charged with developing actionable strategies for overcoming barriers to access to infertility care. Specific barriers addressed included sociocultural, geographic, insurance and financial, outreach to underserved populations and regions around the world, governmental, and male infertility education. Out of that summit came a host of actionable strategies, many of which have already been initiated or put into process. A clear message that emerged from the 2015 Summit was that until infertility is recognized as a disease in the U.S. at all levels, our patients will continue to struggle for fair and reasonable access to infertility care. After all, the body is comprised of the following organ systems: musculoskeletal, circulatory, digestive, endocrine, integumentary, urinary, lymphatic, immune, respiratory, nervous, and reproductive. Disorders of every single organ system have been labelled diseases except for reproduction. The question is, ‘‘What sense does that make?’’ 600

The 1948 United Nations Universal Declaration of Human Rights stated, ‘‘Men and woman of full age, without any limitation due to race, nationality or religion, have the right to marry and to raise a family.’’ This implies not only that those with infertility have the right to treatment, but also that such treatment is of a disease process and not an optional choice for the wealthy only. When repeated in the 1994 United Nations International Conference on Population and Development, this tenant was here to stay. In 2009, the World Health Organization (WHO) recognized infertility as a disease with wide-sweeping changes resulting in how society viewed infertility and how governments recognized infertility care. In fact, in 2013, the Inter-American Commission on Human Rights ruled that a longstanding ban on IVF violated privacy and family rights and was counter to the declaration by the WHO that infertility was a disease. It ruled further that these patients should be allowed infertility treatments. As a result, access to infertility care was provided in Costa Rica. So, what gives in the U.S.? Are our couples with infertility somehow different from those in the rest of the world? Why is this important organ system, reproduction, somehow irrelevant to normal and critical bodily functions? If not a disease, is it a frivolous process? Of course, these implications are all ludicrous. Infertility is a disease and a mandate from the 2015 Access to Care Summit was that the lack of this recognition was a major barrier to all the actionable strategies that had been identified. In May 2017, the ASRM Washington Office led the American Medical Association (AMA) team to take a resolution through the process to the AMA House of Delegates recognizing infertility as a disease. What usually takes several attempts over at least several semi-annual meetings for resolutions to gain the momentum needed for acceptance, took the ASRM resolution one attempt and with little to no opposition at any level from caucuses through committees and then the House of Delegates. A major victory was declared when the final resolution was passed stating, ‘‘Resolved, that our AMA support the World Health Organization's designation of infertility as a disease state with multiple etiologies requiring a range of interventions to advance fertility treatment and prevention.’’ My interpretation is that not only does this resolution recognize infertility as a disease, but it is also coupled with the World Health Organization's designation which provides an added importance and to some degree a sense of urgency. Infertility needs to be accessible and covered by medical insurance just like diseases of all the other organ systems of the human body! The ASRM Access to Care initiative has moved forward on many fronts. At the annual Scientific Congress held in Salt Lake City the President's Plenary Lecture, three abstract sessions, and several symposia and interactive sessions were dedicated to Access to Care. Both challenges and solutions were presented, the latter which ranged from creating more Foundations that assist in helping couples meeting financial challenges to simplified, less costly treatments such as the vaginal incubator. The organizing meeting of a proposed Access to Care Special Interest Group (ACTSIG) was held with 55 attendees. The mandate from our membership was VOL. 108 NO. 4 / OCTOBER 2017

Fertility and Sterility® clear that ASRM should move ahead doing everything possible and on many fronts to address this important need of our patients. Since then plans are being made by the Access to Care Task Force to develop a community on the ASRM website that will allow an ongoing conversation among all those who want to move this agenda forward. In addition, early discussions have been underway to form committees at our upcoming ATCSIG meeting in San Antonio for addressing a handful of the actionable strategies developed at the 2015 summit. Importantly, discussions for a follow-up abbreviated and focused summit are underway so as not to lose the tremendous momentum of this initiative established in 2015. At the ASRM Research Task Force meeting held in Birmingham in January 2017 it was decided that the ASRM would develop a mechanism to fund those areas of research ineligible for funding by the National Institutes of Health (NIH) and would also set funding aside to study various forms of infertility care that would enhance access. An example of what was envisioned as needed clinical ATC research is published in this issue of Fertility and Sterility. Herndon and colleagues from University of California, San Francisco (UCSF) present their findings in what is likely the first study in the U.S. that assesses a low cost and complexity IVF (LCC-IVF) clinical program (4). The population studied was a socially diverse, low resource, urban population of patients with long-term infertility. With an average age of 33.3 years and 5.3 years of infertility, 65 patients started 161 fresh cycles and had 107 oocyte retrievals. These cycles resulted in 91 fresh and 40 subsequent frozen embryo transfers. The total overall costs per patient ranged between $1750 and $2500. The cost savings was primarily based on the use of one of four different mild stimulation protocols coupled with other measures utilized to reduce cost and complexity. While these investigators point out the challenges of the mild stimulation protocols, such as a high cancellation rate, the bottom line is

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that 45% of enrolled patients became pregnant and the cumulative live-birth rate, including thaw cycles, was nearly 30%. While low cost and complexity treatments are often associated with lower success rates, the success achieved here is still remarkable and far higher than the alternativesclomiphene with Intrauterine insemination or no treatment, for examples. The authors are to be congratulated for developing this program for their low resource, socially diverse patients. Let's hope that this study sparks the will and ingenuity of more clinical programs to develop similar and other novel LCC treatments. Richard H. Reindollar, M.D. Department of Obstetrics and Gynecology, Geisel School of Medicine at Dartmouth, Lebanon, New Hampshire; and Department of Obstetrics and Gynecology, University of Alabama School of Medicine, Birmingham, Alabama http://dx.doi.org/10.1016/j.fertnstert.2017.09.002 You can discuss this article with its authors and with other ASRM members at https://www.fertstertdialog.com/users/16110-fertilityand-sterility/posts/19861-24940

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Chandra A, Copen CE, Stephen EH. Infertility service use in the United States: data from the National Survey of Family Growth 1982-2010. Natl Health Stat Rep 2014;22:1–21. ESHRE Capri Workshop Group. Social determinants of human reproduction. Hum Reprod 2001;16:1518–26. Chambers GM, Sullivan EA, Ishihara O, Chapman MG, Adamson GD. The economic impact of assisted reproductive technology: a review of selected developed countries. Fertil Steril 2009;91:2281–94. Herndon C, Anaya Y, Noel M, Cakmak H, Cedars M. Outcomes from a university-based, low cost IVF program providing access to care for a low resource, socio-culturally diverse urban Community. Fertil Steril 2017;108: 642–9.

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Increasing access to infertility care- What will it take?

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