Análisis de la evolución de las especificaciones de los indicadores de calidad del laboratorio de reproducción asistida humana (UNE 179007)

Introduction

Under recent changes in Spanish law, assisted reproduction centres must inform the National Registry of Activity-SEF Registry of their activity and of the results obtained since 2014. The present study analyses the repercussions of these legislative changes on determining the specifications for 32 quality indicators described in the UNE 179007 standard.

Material and methods

A state-of-the-art method was applied to data obtained from the SEF Register (2010-2013), participation in which is voluntary, and from the National Registry of Activity-SEF Registry administered by the Ministry of Health, Social Services and Equality, participation in which has been mandatory since 2014. For each year of the study period, the method used was that described by Buño et al. (2008) for calculating the quality specification at a desirable level. In short, this corresponds to the quality level reached by 75% of the best laboratories (the 25th percentile of the distribution of values for each of the indicators analysed). The 95% confidence interval of the 25th percentile was calculated to determine the margin of error of this estimate.

Results

The imprecision of the studied specifications has decreased, as information was available from almost all the ART centres in Spain. Our results corroborate the robustness of the state-of-the-art method, with 85% (26/32) of the quality indicator specifications remaining stable over time. Significant changes were only observed in 6 indicator specifications. The 2 specifications that increased significantly were “Survival rate to cryopreservation of embryos from donated and own fresh oocytes” and “Percentage of embryos in evolution or used”. On the other hand, there were significant decreases for “Mean number of pre-embryos transferred fresh from own oocytes”, “Percentage of gestation by embryo transfer from fresh own oocytes” and “Multiple gestation rate in IVF/ICSI cycles”.

Discussion

The significant increases observed in the specifications of some indicators reflect changes in clinical practice. Nevertheless, it is necessary to improve the validity of some UNE quality indicators, since with their current formulation, the quality of the treatment provided cannot be determined.