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Tracking quality: can embryology key performance indicators be used to identify clinically relevant shifts in pregnancy rate?
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- Additional Information
- Source:
Publisher: Oxford University Press Country of Publication: England NLM ID: 8701199 Publication Model: Print Cited Medium: Internet ISSN: 1460-2350 (Electronic) Linking ISSN: 02681161 NLM ISO Abbreviation: Hum Reprod
- Publication Information:
Publication: Oxford, UK : Oxford University Press
Original Publication: Oxford ; Washington, DC : Published for the European Society of Human Reproduction and Embryology by IRL Press, [c1986-
- Subject Terms:
- Abstract:
Study Question: Can embryology key performance indicators (KPIs) detect shifts in laboratory performance that precede changes in clinical outcomes?
Summary Answer: Day 5 usable blastocyst rate (D5BUR) is an important embryology KPI that complements total usable blastocyst rate (TBUR) in its ability to rapidly identify adverse embryology outcomes, prior to changes in clinical outcomes.
What Is Known Already: The hypothesis that monitoring performance of an IVF laboratory using statistical process controls (SPCs) can act as an early warning signal of shifts in laboratory conditions is a hypothesis that requires validation. The Vienna consensus report recently defined KPIs for monitoring fresh IVF and ICSI cycles, but the effectiveness of using these KPIs for detecting clinically relevant shifts following changes in laboratory processes is unknown.
Study Design, Size, Duration: A retrospective, multicentre, analysis of KPIs for 1971 fresh IVF and ICSI cycles during three consecutive 5-month periods (P1, P2 and P3) during which the culture medium was changed in the middle period.
Participants/materials, Setting, Methods: ICSI fertilisation rate, IVF fertilisation rate, D5BUR, TBUR and clinical pregnancy rate (CPR) were tracked monthly and analysed for SPC using Shewhart control charts. Out-of-control KPIs were identified by warning (2-sigma) and control (3-sigma) limits. The effect of the laboratory culture medium change on embryology KPIs and cumulative CPR was investigated using a one-way ANOVA or Pearson Chi-squared test and logistic regression.
Main Results and the Role of Chance: D5BUR decreased from 32 to 25% after the culture medium was changed, and the decrease was detected within 1 week after the change (P < 0.0001). D5BUR subsequently increased after a change back to the original medium. A decrease in CPR (51-36%) after the medium change was also observed but was not detected until 3 months after the shift in D5BUR (P = 0.0005). Overall, the change in culture medium independently influenced D5BUR, CPR and cumulative CPR. Importantly, TBUR (41%) was not affected by the change in culture medium, remaining within control limits for all three culture periods, indicating that the overall blastocyst rate alone may not sufficiently monitor embryology laboratory performance.
Limitations Reasons for Caution: The statistical KPI monitoring system demonstrated by the current study may be less effective at identifying KPI shifts in smaller clinics with lower cycle volumes. Live-birth rate per cycle started was not included as a clinical KPI.
Wider Implications of the Findings: This study demonstrates that statistical KPI monitoring systems have the potential to provide systematic, early detection of adverse outcomes in ART laboratories after planned or unexpected shifts in conditions.
Study Funding/competing Interest(s): No external funds were used for the study. The authors have no conflicts of interest.
Trial Registration Number: Not applicable.
- Comments:
Erratum in: Hum Reprod. 2019 Apr 1;34(4):780. (PMID: 30715339)
- Publication Date:
Date Created: 20181206 Date Completed: 20190813 Latest Revision: 20220409
- Publication Date:
20221213
- Accession Number:
10.1093/humrep/dey349
- Accession Number:
30517659
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