Clinical Investigation: Prospective Evaluation of Statistical Process Control for IVF Lab Quality Management

The purpose of this investigation is to gather information that will allow the creation of real time quality assessment and management tools for ART units.


100 ART Centers are being recruited internationally for this study. Participating units will be provided a year's subscription to a cloud-based IVF laboratory electronic medical record (EMR,                                                      ) for data collection at no cost. The EMR software creates a separate record for each oocyte, tracking it from egg retrieval to embryo transfer or cryopreservation. These data will be used to create mean embryo scores and other metrics for each lab case. Clinical pregnancy outcome data will be collected as a primary outcome variable.


At the conclusion of the study data will be evaluated in a clinic-identity and patient-identity obscured fashion. Statistical process control analysis will be applied to each step of the ART process from egg retrieval to embryo transfer and pregnancy outcome. Our goals are to confirm that statistical process control results correlate with clinical pregnancy success and to determine if excess process variation in specific aspects of the IVF process is correlated with impaired performance and hence may identify points for remediation. Each clinic will receive a confidential report detailing their process control analysis.



                                 to contact Alex Steinleitner MD for more information regarding study participation.

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