ObjectiveKPIs have been employed for internal quality control (IQC) in ART. However,
clinical KPIs (C-KPIs) such as age, AMH and number of oocytes collected are
never added to laboratory KPIs (L-KPIs), such as fertilization rate and
morphological quality of the embryos for analysis, even though the final
endpoint is the evaluation of clinical pregnancy rates. This paper analyzed
if a KPIs-score strategy with clinical and laboratorial parameters could be
used to establish benchmarks for IQC in ART cycles.MethodsIn this prospective cohort study, 280 patients (36.4±4.3years)
underwent ART. The total KPIs-score was obtained by the analysis of age, AMH
(AMH Gen II ELISA/pre-mixing modified, Beckman Coulter Inc.), number of
metaphase-II oocytes, fertilization rates and morphological quality of the
embryonic lot.ResultsThe total KPIs-score (C-KPIs+L-KPIs) was correlated with the presence or
absence of clinical pregnancy. The relationship between the C-KPIs and
L-KPIs scores was analyzed to establish quality standards, to increase the
performance of clinical and laboratorial processes in ART. The logistic
regression model (LRM), with respect to pregnancy and total KPIs-score (280
patients/102 clinical pregnancies), yielded an odds ratio of 1.24 (95%CI =
1.16-1.32). There was also a significant difference (p<0.0001) with
respect to the total KPIs-score mean value between the group of patients
with clinical pregnancies (total KPIs-score=20.4±3.7) and the group
without clinical pregnancies (total KPIs-score=15.9±5). Clinical
pregnancy probabilities (CPP) can be obtained using the LRM (prediction key)
with the total KPIs-score as a predictor variable. The mean C-KPIs and
L-KPIs scores obtained in the pregnancy group were 11.9±2.9 and
8.5±1.7, respectively. Routinely, in all cases where the C-KPIs score
was ≥9, after the procedure, the L-KPIs score obtained was ≤6,
a revision of the laboratory procedure was performed to assess quality
standards.ConclusionThis total KPIs-score could set up benchmarks for clinical pregnancy.
Moreover, IQC can use C-KPIs and L-KPIs scores to detect problems in the
clinical-laboratorial interface.