Lessons Learned from the World IVF
The main lessons learned from the World IVF Register are two:
First, the monitoring of IVF/ICSI outcomes is a must for all countries involved in ART. It is necessary to build and to maintain confidence in the quality of ART. This can only be done by “keeping a finger on the pulse”.
Second, to monitor efficacy is not sufficient. We need to know also about safety. The monitoring of efficacy is relatively easy. Monitoring of safety is much more difficult.
Five World Reports have been published by our committee, so far (1991, 1993, 1995, 1997, and 2001). The sixth report is scheduled to be published during 2004; data collection is ongoing.
Data presented in the latest report from 2001 were collected from 1,504 clinics in 44 countries, from all continents. The report includes nearly 300,000 treatment cycles started during 1998. This is cohort data, which includes follow-up data until delivery, whenever possible. We estimate that the report covers some 75-80 % of all cycles started that year, the total estimated global number of IVF/ICSI cycles for 1988 being around 400,000.
Global reporting is expanding very rapidly. Data from the previous world report, from 1997, included about 225,000 cycles, the increase from 1997 to 2001 being 77 %. This dramatic difference is the result of both increasing ART activity and better data collection systems in many countries.
The data presented in these reports cover the efficacy of IVF/ICSI rather than safety, with one very important exception: data on multiple pregnancy and delivery, which are indeed indicators of safety (or complications, really) rather than efficacy. The report also contains data on the number of embryos transferred, but not data on fetal reduction which is practiced in some countries.
To account for efficacy is not as easy as it may seem. There are several options to choose from, with pros and cons for each. In fact, patients, health care providers, the public at large, allocators of resources and others may need different descriptions of efficacy.
Should we count pregnancies, known within a few weeks after treatment or should we wait for deliveries? Or should we count singleton deliveries or even healthy singletons only as the most appropriate outcome? The fourth alternative is maybe the most appropriate but requires a very sophisticated and thorough follow-up and that is not widely available, is expensive, takes a long time to develop and, even when in place, it takes several years after birth to determine whether or not the outcome is a “healthy baby”.
Should we count per cycle started or per aspiration or per embryo transfer for the denominator of our success rate? Or should we even count “combined rates” which includes also transfers of thawed embryos? Or should we count pregnancies/deliveries per embryo transferred rather than by procedures performed?
Maybe we should not aim at using one rate for all purposes.
Data from population based Health Registers in some countries have convincingly shown that multiple pregnancy and delivery is the most important indicator of increased medical risks for children and women. In several countries opportunities for such thorough follow-up of IVF children are lacking. Therefore, for information regarding safety, many countries depend on regional rather than national data collection. In Europe, for example, ESHRE is planning to set up a European Safety Data Base where available safety data from countries where such data are available can be assembled and shared by all.
All countries need to monitor the efficacy as well as the safety of their ART activities. This is “to keep a finger on the pulse”. Monitoring ART is no longer an option, it’s a must. Data are needed for couples, professionals, the public at large, the media, law-makers and for the allocation of money. A generous reimbursement policy for ART certainly depends on high quality monitoring.
Regional and world data are helpful where national data are not available and also for comparison. Comparison is used to elucidate the situation in your own setting, to give intellectual ammunition for national debate.
Common definitions in the field of infertility and ART are badly needed. ICMART has developed a glossary, now adopted by a WHO expert meeting and also by ESHRE´s EIMs Consortium for European IVF reporting. At present we are seeking endorsement elsewhere as well. We certainly hope to get the support of the IFFS .
Complete coverage, high follow-up rates for IVF deliveries and solid validation systems are prominent in some countries, but insufficient in others. International work-shops to help improve data quality have recently been held by ICMART in Cairo for the Middle East and by ESHRE and the EIMs Consortium in Bologna for Europe. Another workshop for the same purpose will take place in Thessalonica for Balkan countries in September of 2004. Additional workshops are also planned, for example in Beijing by ICMART for China.
We need to refine further our techniques for monitoring ART efficacy and safety. We need “a finger on the pulse”. We need to know. By doing so we are building confidence in ART for everyone involved with this wonderful, but still young, technology and especially for our patients.
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