Design and validation of a model for quality control monitoring of dichotomous in vitro fertilization outcomes

Objective: To develop and validate a practical model for quality control monitoring of dichotomous in vitro fertilization (IVF) outcomes such as pregnancy resulting from the transfer of euploid blastocysts. Design: We designed and validated a model for quality control monitoring of dichotomous IVF outcomes. We demonstrate use of this model for assessment of euploid blastocyst transfer quality control based on fetal heartbeat rate per embryo. The model uses 3 weighted moving averages with window sizes of 21, 51, and 101 embryo transfers to detect short and long-term shifts in success rates. The quality warning limit was set to have a 2-sided type I error rate of 0.30 per 100 embryo transfers and the control limit was set to have a type I error rate of 0.05 per 100 embryo transfers. Simulation studies were performed to validate the model through assessment of type I and type II errors using custom computer programs. Setting: Not applicable. Patient(s): Patients undergoing IVF. Intervention(s): None. Main Outcome Measure(s): Type I and type II error rates and statistical power analysis. Result(s): Validated quality warning and control limits are presented for a range of expected outcome rates. The power to detect a 20% decrease from an expected fetal heartbeat rate of 50%, when the decrease persisted for 50 embryo transfers, was 86% for the warning limit and 57% for the control limit. Conclusion(s): This model can be used for continuous quality control assessment of dichotomous IVF outcomes such as pregnancy rates.