ESHRE's role in the assembly of 'big data' for monitoring IVF performance and safety

A full house of members of the EIM Consortium at it latest meeting in November.

Published 29 November 2018

A closed meeting of the European IVF Monitoring (EIM) Consortium, which involved representatives of almost all member nations, outlined the achievements of its data collections as well as the continuing challenges.

After 18 years of data collection, the challenges facing ESHRE's European IVF Monitoring (EIM) Consortium continue to be as great as the developments in this ever-changing field. The Consortium's Chairman, Christian De Geyter, described ART and the demands of gathering data as 'increasingly complex', noting among those complexities technology, policy, follow-up and the organisation of centres themselves.

Yet from the reports of many of those representing the grass roots of less prominent members of the Consortium, money and funding seemed their most severe headache. It was a remarkable achievement that almost all national members of the EIM were represented at this closed meeting, with reports from Armenia, Georgia, Slovakia, Bosnia and Serbia. Yet these are countries which have rarely or irregularly submitted their local registry data to EIM, and seem unlikely to do better because of inadequate funding and local budgetary priorities. Money, quite clearly, is a challenge for these countries, and one action step to emerge from this meeting was the development of a software program to ease the challenge. 'We need to start,' said Georgia's representative Lika Chkonia, 'but how do we start?'

Deirdre Fehily, speaking for the European Commission, emphasised that 'tissue establishments' have a requirement to submit an annual report on their activities to their competent authority, but some clinics are clearly failing to meet that obligation - nor competent authorities to encourage it. The result for ESHRE is that data gathered from national registers now represent just 83% of total European activity in ART, with fewer than one half of member countries submitting full registry data.

These data, according to Christine Wyns, who at the Annual Meeting in Vienna in 2019 will become the next EIM Chairman, is presently cross-sectional and thus representative of no more than an aggregate snapshot activity in a given year. Yet this, as the annual EIM reports reaffirm, has enormous value in providing a reliable basis for national and annual comparison. As Veerle Goossens, ESHRE's scientific officer responsible for data collection and analysis, said, the EIM annual reports show beyond doubt a steady increase in activity (overall and national) and in pregnancy rate. Nowhere is such a wealth of 'big data' in IVF available, and it's clear that organisations like the European Commission, Council of Europe and WHO are now looking at it with increasing interest to monitor safety and provide consumer guidance.

On the wish-list of Christine Wyns was the collection of cumulative data, which, she said, would provide a 'more realistic presentation' of success in IVF. It would also, she added, accommodate the increasing presence of cryopreservation in modern ART. However, after reviewing four examples of cumulative data collection (including that of SART), it was evident that the demands of following patients (and not just describing a cycle) are likely to prove a substantial challenge. 'But we need a consensus on when to start,' said Wyns.

Certainly, as De Geyter observed at the outset, technology has added complexity to data collection, and nowhere has this been more evident than in the mini-revolution inspired by vitrification. Patterns of frozen embryo transfer and egg donation each showed substantial gains in the latest round of EIM data (for 2015), a trend likely to continue with the greater uptake of freeze-all embryos. Monitoring a freeze-all approach in a given year will clearly pose chronological problems. And similarly, the preponderance of egg banking for egg donation will surely spell the demise of traditional egg donation (and much cross-border treatment) performed in a fresh cycle. Why endure the wait for a match, the trip to an overseas clinic, the synchronised cycle, when suitable vitrified eggs are readily available in an egg bank somewhere in the world (but preferably at home)? Cross-border treatments are already a problem for EIM, which egg banking is likely to make even more complicated in the years ahead.

However, despite such challenges, the message from this stimulating meeting was that registry data can be collected in a meaningful way and as a complement to clinical trials. Indeed, as Deirdre Fehily observed, ESHRE now has a significant stakeholder place in many of the Commission's projects (in evaluating the Tissue and Cell Directives prior to an update, in consultation with competent authorities, and in clinical briefings). Fehily also described a growing responsibility in the Commission for consumer 'transparency', which in ART seems now concentrated on access to care, safety for donors and gamete recipients (vigilance) and efficacy. And to this end De Geyter himself stressed the need for added vigilance in ESHRE's monitoring of registry data, in better identifying and characterising any adverse events, in particular with respect to children born after ART.

The EIM data set will thus be central to the Commission's own common data set in support of these initiatives. 'Registries play a key role in the field of human application of substances of human origin,' said Fehily, and clearly ESHRE's EIM accumulated data, whatever its shortcomings or its challenges, can now play a central part.