Aims: Intracytoplasmic sperm injection is a method of assisted reproduction (AR) covered by Statutory Health Care in Germany, since the guidelines of the concerned health authority (Bundesausschuss der Arzte und Krankenkassen--national board of medical doctors and health care insurance) have been changed in 2002, although open questions concerning its risk profile still exist. It is desirable to consider how collection and handling of data about these treatments can be utilised, so that the risks associated with assisted reproduction can be minimised and procedures be regulated in an adequate manner. Therefore this paper investigates the requirements of a national register in order to achieve a fact-based comparison of results.
Method: Factors influencing the problems around malformation rate and multiple pregnancy in assisted reproduction were searched for in international literature and traced in documentation already available in the German context. Pathways for collection and handling of the problem-associated data are suggested.
Results: Up to now relevant data are kept separately. Data links are a precondition, if the existing documentation collected for different purposes should be used to evaluate and survey AR activities. This applies to the following long-standing German data collections: perinatologic and neonatologic survey, obstetric and paediatric patient documentation and the IVF registry. Further more data links to death cause registry and public health data (e. g. health check for school entering children) have to be considered. Comparing different types of international registration best surveys were found by compulsory registries under official control.
Conclusions: Results are suitable for comparison if treatment is carried out under equivalent circumstances and complete standardized data are collected. Foreign examples show that appropriately designed registries contribute to effective assessment in reproductive health technology. Institution-based data aggregation enables benchmarking as means of quality improvement.