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“Nobody left behind”

the role of data registries in assisted reproductive technology

Dyer, Silke, PhDa,; Zegers-Hochschild, Fernando, MDb

Global Reproductive Health: March 2019 - Volume 4 - Issue 1 - p e26
doi: 10.1097/GRH.0000000000000026
Commentary
Open

aDepartment of Obstetrics & Gynaecology, Groote Schuur Hospital and Faculty of Health Sciences, University of Cape Town, Cape Town, South Africa

bClinica las Condes and Program of Ethics and Public Policies in Human Reproduction, University Diego Portales, Santiago, Chile

Sponsorships or competing interests that may be relevant to content are disclosed at the end of this article.

Published online 7 January 2019

Corresponding author. Address: Department of Obstetrics and Gynaecology, Groote Schuur Hospital and Faculty of Health Sciences, University of Cape Town, Observatory 7925, Cape Town 7925, South Africa. Tel.: +27-21-404-4485; fax: +27-21-448-6921. E-mail address: silke.dyer@uct.ac.za (S. Dyer).

This is an open access article distributed under the terms of the Creative Commons Attribution-NonCommercial-ShareAlike 4.0 License, which allows others to remix, tweak, and build upon the work non-commercially, as long as the author is credited and the new creations are licensed under the identical terms. http://creativecommons.org/licenses/by-nc-sa/4.0/

Received September 3, 2018

Accepted November 20, 2018

“The freedom for all to live a flourishing life” is the big vision that underpins world-wide action and advocacy for human development. High-level global strategies, including the Sustainable Development Goals and United Nations Human Development Report, present plans of action that “nobody is left behind”1.

Central to living a flourishing life is the freedom and human right to found a family and have children. In the case of infertility, nobody is left behind if those who wish to access care have the freedom to do so; and, beyond access, find evidence-based treatment with a transparent track-record pertaining to outcomes.

One of the international markers used to reflect access to infertility care is the number of assisted reproductive technology (ART) cycles per million inhabitants. Although numbers mean different things in different communities, it has been accepted that access is met if 3000 couples per million population undergo ART per annum2. This estimate is derived from an algorithm which considers infertility prevalence, non-ART pregnancies as well as treatment-independent pregnancies. However, it must be stated that the demand for treatment can be reduced to half of this theoretical need. Many factors are responsible, such as the influence of religion, as well as cultural and educational factors.

Qualitatively, the freedom to access infertility care is met if interventions are available, affordable and acceptable. Affordability pertains to the ability of the individual or the society to pay for the intervention without incurring undue financial risks or harm. Availability comprises physical presence of facilities and interventions within reach of consumers. Acceptability implies that an intervention is acceptable to the patient and vice versa. In all of these domains, visible and invisible biases exist. In many health systems, poverty creates prominent and visible barriers in the affordability domain—and often similarly prominent but less visible barriers in the acceptability domain.

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Creating visibility

National, regional, and global registries that document and monitor ART activity, provide valuable, annual data pertaining to ART availability, utilization, effectiveness, and safety. Their most immediate value lies in creating visibility of these indicators by country, region, year, and over time. Sixty-five countries and 2560 centers submitted data to the latest ICMART World Report3. According to these, global ART utilization was 477 cycles per million population in 2011. Effectiveness of fresh nondonor IVF and ICSI was reflected in a pregnancy rate per aspiration of 24.0% and 26.2%. Safety indicators showed a continuing trend of a lowering mean number of embryos transferred (1.91) and a gradual reduction in the multiple birth rate (MBR; 20.5%) compared with previous years. Disaggregation to regional and country level offers insight into similarities and differences; and unveils inequalities and inequities in utilization and outcomes. Specifically, ART utilization in 2011 was lowest in sub-Saharan Africa (71) and Latin America (184) and highest in Australia/New Zealand (2489) and Europe (1022). Africa’s low utilization may partly be due to underreporting as a regional registry has only recently been initiated, but this does not apply to Latin America where a long-standing and comprehensive regional registry captures nearly 80% of ART activity in 15 countries. It is thus a reliable estimate that women in Latin America had 7.4% of the utilization of women living in Australia and New Zealand. Furthermore, women in sub-Saharan Africa had a mean of 2.83 embryos transferred with a MBR of 28.2%, while those living in Northern Europe increasingly underwent single embryo transfer with MBR in the order of 5%.

Such large-scale observations can then be further interrogated through regional and national registry data, especially if these are cycle-based; we can therefore examine whether the age of women is comparable between different regions, and the effect of out of pocket funding versus national plans for reimbursement. These factors influence the number of embryos transferred and thus the way in which patients balance the risks of MBR versus having no children at all. This delicate balance is especially relevant in many developing countries where couples have to travel long distances or pay large sums of money for one chance in their lifetime.

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Creating impact

Once registry data are released through the standard avenues of scientific communication, they create impact. National, regional, and global benchmarks are made available against which individual centers and countries can compare themselves. These benchmarks are also used for accreditation purposes by reproductive networks such as RedLARA (Latin American Network and Registry for ART) and more recently ESHRE.

Fertility organizations or government bodies use registry data to inform guidelines or regulations, for example pertaining to the number of embryos transferred or an upper age limit for women undergoing public-treatment.

Evidently, data registries provide large and valuable research data from which answers can be drawn to inform clinical and laboratory practices. Other associations may also become visible. Using ICMART data, a negative association between gender inequality and ART utilization has recently been shown: the greater the gender-inequality the lower the ART utilization4.

Last but not least, registries inform patients, governments and the public. Strong and visible data enhance provision and acceptance of ART. There are multiple examples where national and regional registries contribute to the generation of public policies based on local evidence. This is the case in three countries in Latin America where laws have been introduced to provide universal access to ART and which in their ruling used data provided by the regional registry. ART utilization in Europe has been shown to be connected to its socio-cultural acceptance independently of a country’s GDP5. In contrast, in African countries where historically registry data did not exist, lack of patient awareness and falsely negative misconceptions of ART often still prevail.

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Creating harmony

In addition to creating visibility and downstream impact, registries also bring value to what lies upstream of data collection: harmonization of people and of data. The building of registries, both historical and current, requires creating and maintaining a shared vision and mission among ART centers. This is irrespective of whether participation is mandatory or voluntary as legal requirements function best with buy-in from the collective; and where laws do not exist, no data will be shared in the absence of basic harmony. Collaboration in turn facilitates professional governance, scientific meetings, capacity building, and better representation of patients and ART centers themselves.

The harmonization of data requires a common scientific terminology. This is provided by the International Glossary of Infertility and Fertility Care and comes as the result of extensive scientific collaboration led by ICMART, facilitated by WHO, and with participation from fertility and patient organizations6. In addition, scientific consensus is required what represents mandatory, core data and how best to capture ART practices and their evolution within registries.

Harmonization of people and data must be generated at national, regional and global level. Each tier has its own challenges—and stands to benefit. The result are data that are nationally, regionally and globally representative of “real life” ART or the best approximation of such representativeness; are generated annually, comparable and allow monitoring of trends; and are freely available to many stakeholders.

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Africa and Latin America: 2 regional examples

The above is illustrated by the oldest and the youngest regional ART registry: RedLARA, the Latin American Registry and Network for ART, and ANARA, the African Network and Registry for ART. The Latin American Registry was founded in the early 1990s. Recognizing the importance of collaboration led to the building of the network (Red) and establishment of RedLARA. Since inception, the registry has reported on the outcomes and practices of ART: to begin with 2415 cycles from 8 countries; and in 2014 55,840 procedures from 15 countries (www.redlara.com). Retrospective summary data have given way to cycle-based data captured with software that evolves along-side the registry and ART practices. Data are reported and published in the scientific domain and inform governments and the public. Benefits are many and well-illustrated by 20th anniversary goals of the Network: to make ART more accessible and to improve safety by reducing the number of embryos transferred.

Africa has lagged far behind the establishment of registries. In the last 25 years the landscape of ART has been characterized by a sparsity of scientific data, little collaboration, few scientific meetings (largely informed by speakers and science from outside Africa), scant interests from governments, and low fertility health literacy of patients and the public. It is of no surprise but nonetheless concerning that according to the latest ICMART World Data, Africa conducted ∼1% of ART procedures globally3. This is the result of ART scarcity as well as low rates of data reporting.

In the last 3 years ANARA has, however, established itself with considerable developmental support from RedLARA, including software donation, as well as guidance from ICMART. As a young network and registry, focus is directed at creating harmony among people, overcoming barriers to data sharing, and developing capabilities among ART centers for data collection. First success in creating visibility has been achieved, and national, subregional and regional data have been presented at scientific meetings in Nigeria, Togo, Uganda, and Egypt. First findings relate to low rates of ART utilization, high usage of ICSI, favorable pregnancy rates but with high rates of multiples, and lack of delivery data. Data from 40 centers in 13 countries are now in press7. While the data still have relevant limitations including limited representativeness, it is anticipated that ANARA will grow and that future data will become more robust. It is too early to evaluate impact, but—based on the experience from Latin America and other world regions—there is good reason to believe that the registry will ultimately help to reduce the burden of infertility in Africa.

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Conclusions

Globally, many infertile patients are at risk of being left behind: because they do not have the freedom to access ART, or because the only ART accessible lacks a transparent record of effectiveness and safety. ART registries can contribute to close the gap by bringing together ART centers and data, providing visibility on current and changing status of ART, and distributing these data to stakeholders for wide use and impact.

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Conflict of interest disclosures

The authors declare that they have no financial conflict of interest with regard to the content of this report.

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References

1. Jāhāna S. Human development report 2016: human development for everyone: United Nations Publications. 2016.
2. Eshre Capri Workshop Group. Social determinants of human reproduction. Hum Reprod 2001;16:1518–26.
3. Adamson GD, de Mouzon J, Chambers GM, et al. International Committee for Monitoring Assisted Reproductive Technologies World Report on assisted reproductive technologies, 2011. Fertil Steril 2018;110:1067–1080.
4. Chambers G, Fitzgerald O, Dyer S, et al. Gender inequality and utilisation of assisted reproductive technology: an international analysis. Hum Reprod 2018;33(supp 1):i65.
5. Präg P, Mills MC. Cultural determinants influence assisted reproduction usage in Europe more than economic and demographic factors. Hum Reprod 2017;32:2305–2314.
6. Zegers-Hochschild F, Adamson GD, Dyer S, et al. The international glossary on infertility and fertility care, 2017. Hum Reprod 2017;32:1786–1801.
7. Dyer S, Archary P, de Mouzon J, et al. Assisted reproductive technologies in Africa: first results from the African Network and Registry for Assisted Reproductive Technology, 2013. Reprod Biomed Online 2018. Doi: 10.1016/j.rbmo.2018.11.001.
Copyright © 2019 The Authors. Published by Wolters Kluwer on behalf of the International Federation of Fertility Societies. All rights reserved.