Embriyoloji Laboratuvarları Performans Kriterleri
Özet
Tüp bebek tedavisi, çeşitli faktörlerin yer aldığı oldukça karmaşık bir dizi klinik prosedürü içermektedir ve laboratuvarda bu faktörlerin doğru bir şekilde senkronize edilmesi tüp bebek prosedürlerinin başarısı için kritik öneme sahiptir. Anahtar performans göstergeleri (key performance indicator-KPI), toplanan oosit sayısından gebelik oranlarına kadar her süreci kapsayan nicel ölçümlerdir ve laboratuvar verimliliğinin kapsamlı değerlendirilmesini sağlarlar. Laboratuvar prosedürlerinin güvenilirliği ve tutarlılığı, başarı oranlarını etkileyebilecek sapmalara karşı koruma sağlayan kalite kontrol protokollerinin etkin bir şekilde uygulanmasıyla garanti altına alınmaktadır. (1-3) IVF laboratuvar performansının optimizasyonu büyük ölçüde risk azaltma, sürekli iyileştirme ve yasal mevzuatlara uyumluluğu içeren kalite yönetimine bağlıdır. Bu bölümde; IVF laboratuvar performansının önemli bileşenleri olan anahtar performans göstergeleri ve kalite kontrol ve kalite yönetim sistemlerinin önemli rolü anlatılmaktadır. (2,4,5)
Referanslar
Curchoe CL, Bormann C, Hammond E, et al. Assuring quality in assisted reproduction laboratories: assessing the performance of ART Compass - a digital art staff management platform. Journal of Assisted Reprodution and Genetics. 2023 Feb;40(2):265-278. doi: 10.1007/s10815-023-02713-2. Epub 2023 Jan 13. PMID: 36637586; PMCID: PMC9935773.
Scott RT Jr, de Ziegler D. Introduction: Key performance indicators in assisted reproductive technologies. Fertilty and Sterility. 2020 Jul;114(1):4-5. doi: 10.1016/j.fertnstert.2020.04.057. Epub 2020 Jun 9. PMID: 32532497.
Mortimer ST, Mortimer D. Quality and Risk Management in the IVF Laboratory. 2nd ed. Cambridge: Cambridge University Press; 2015. p. 1–5.
ESHRE Special Interest Group of Embryology and Alpha Scientists in Reproductive Medicine. The Vienna consensus: report of an expert meeting on the development of ART laboratory performance indicators. Reproductive Biomedicine Online. 2017 Nov;35(5):494-510. doi: 10.1016/j.rbmo.2017.06.015. Epub 2017 Aug 4. PMID: 28784335.
ESHRE Special Interest Group of Embryology; Alpha Scientists in Reproductive Medicine. The Vienna consensus: report of an expert meeting on the development of art laboratory performance indicators. Hum Reprod Open. 2017 Aug 4;2017(2):hox011. doi: 10.1093/hropen/hox011. PMID: 31486806; PMCID: PMC6276649.
Gardner DK, Balaban B. Choosing between day 3 and day 5 embryo transfers. Clinical Obstetry and Gynecololgy, 2006 Mar;49(1):85-92. doi: 10.1097/01.grf.0000197501.06958.8b. PMID: 16456345.
Fabozzi G, Cimadomo D, Maggiulli R, et al. Which key performance indicators are most effective in evaluating and managing an in vitro fertilization laboratory? Fertility and Sterility. 2020 Jul;114(1):9-15. doi: 10.1016/j.fertnstert.2020.04.054. Epub 2020 Jun 9. PMID: 32532495.
Alpha Scientists In Reproductive Medicine. The Alpha consensus meeting on cryopreservation key performance indicators and benchmarks: proceedings of an expert meeting. Reproductive Biomedicine Online. 2012 Aug;25(2):146-167. doi: 10.1016/j.rbmo.2012.05.006. Epub 2012 May 29. PMID: 22727888.
ESHRE Clinic PI Working Group; Vlaisavljevic V, Apter S, Capalbo A, et al. The Maribor consensus: report of an expert meeting on the development of performance indicators for clinical practice in ART. Human Reproduction Open. 2021 Jul 3;2021(3):hoab022. doi: 10.1093/hropen/hoab022. PMID: 34250273; PMCID: PMC8254491.
Pirtea P, de Ziegler D, Poulain M, et al. Which key performance indicators are optimal to assess clinical management of assisted reproduction cycles? Fertility and Sterility. 2020 Jul;114(1):24-30. doi: 10.1016/j.fertnstert.2020.04.055. Epub 2020 Jun 10. PMID: 32532485.
Choucair, F., Younis, N., Hourani, A. The value of the modern embryologist to a successful IVF system: revisiting an age-old question. Middle East Fertility Society Journal, 26, 15 (2021). doi.org/10.1186/s43043-021-00061-8
Olofsson JI, Banker MR, Sjoblom LP. Quality management systems for your in vitro fertilization clinic's laboratory: Why bother? Journal of Human Reproductive Sciences. 2013 Jan;6(1):3-8. doi: 10.4103/0974-1208.112368. PMID: 23869142; PMCID: PMC3713573.
Vaiarelli A, Zacà C, Spadoni V, et al. Clinical and laboratory key performance indicators in IVF: A consensus between the Italian Society of Fertility and Sterility and Reproductive Medicine (SIFES-MR) and the Italian Society of Embryology, Reproduction and Research (SIERR). Journal of Assisted Reproduction and Genetics. 2023 Jun;40(6):1479-1494. doi: 10.1007/s10815-023-02792-1. Epub 2023 Apr 24. PMID: 37093443; PMCID: PMC10310668.
Working Group on the update of the ESHRE/ALPHA Istanbul Consensus; Coticchio G, Ahlström A, et al. The Istanbul consensus update: a revised ESHRE/ALPHA consensus on oocyte and embryo static and dynamic morphological assessment. Human Reproduction. 2025 Apr 28:deaf021. doi: 10.1093/humrep/deaf021. PMID: 40288770.
Coticchio, Giovanni et al. The Istanbul Consensus update: a revised ESHRE/ALPHA consensus on oocyte and embryo static and dynamic morphological assessment. Reproductive BioMedicine Online, 2025, Volume 50, Issue 6, 104955
Hammond ER, Morbeck DE. Tracking quality: can embryology key performance indicators be used to identify clinically relevant shifts in pregnancy rate? Human Reproduction. 2019 Jan 1;34(1):37-43. doi: 10.1093/humrep/dey349. Erratum in: Hum Reprod. 2019 Apr 1;34(4):780. PMID: 30517659.
Coticchio G, Behr B, Campbell A, et al. Fertility technologies and how to optimize laboratory performance to support the shortening of time to birth of a healthy singleton: a Delphi consensus. Journal of Assisted Reproduction and Genetics. 2021 May;38(5):1021-1043. doi: 10.1007/s10815-021-02077-5. Epub 2021 Feb 18. PMID: 33599923; PMCID: PMC8190195.
Zacà C, Coticchio G, Vigiliano V, et al. Fine-tuning IVF laboratory key performance indicators of the Vienna consensus according to female age. Journal of Assisted Reproduction and Genetics. 2022 Apr;39(4):945-952. doi: 10.1007/s10815-022-02468-2. Epub 2022 Mar 26. PMID: 35338418; PMCID: PMC9050984.
Bormann CL, Curchoe CL, Thirumalaraju P, et al. Deep learning early warning system for embryo culture conditions and embryologist performance in the ART laboratory. Journal of Assisted Reproduction and Genetics. 2021 Jul;38(7):1641-1646. doi: 10.1007/s10815-021-02198-x. Epub 2021 Apr 27. Erratum in: Journal of Assisted Reproduction and Genetics. 2021 May 14;: PMID: 33904010; PMCID: PMC8324654.
Referanslar
Curchoe CL, Bormann C, Hammond E, et al. Assuring quality in assisted reproduction laboratories: assessing the performance of ART Compass - a digital art staff management platform. Journal of Assisted Reprodution and Genetics. 2023 Feb;40(2):265-278. doi: 10.1007/s10815-023-02713-2. Epub 2023 Jan 13. PMID: 36637586; PMCID: PMC9935773.
Scott RT Jr, de Ziegler D. Introduction: Key performance indicators in assisted reproductive technologies. Fertilty and Sterility. 2020 Jul;114(1):4-5. doi: 10.1016/j.fertnstert.2020.04.057. Epub 2020 Jun 9. PMID: 32532497.
Mortimer ST, Mortimer D. Quality and Risk Management in the IVF Laboratory. 2nd ed. Cambridge: Cambridge University Press; 2015. p. 1–5.
ESHRE Special Interest Group of Embryology and Alpha Scientists in Reproductive Medicine. The Vienna consensus: report of an expert meeting on the development of ART laboratory performance indicators. Reproductive Biomedicine Online. 2017 Nov;35(5):494-510. doi: 10.1016/j.rbmo.2017.06.015. Epub 2017 Aug 4. PMID: 28784335.
ESHRE Special Interest Group of Embryology; Alpha Scientists in Reproductive Medicine. The Vienna consensus: report of an expert meeting on the development of art laboratory performance indicators. Hum Reprod Open. 2017 Aug 4;2017(2):hox011. doi: 10.1093/hropen/hox011. PMID: 31486806; PMCID: PMC6276649.
Gardner DK, Balaban B. Choosing between day 3 and day 5 embryo transfers. Clinical Obstetry and Gynecololgy, 2006 Mar;49(1):85-92. doi: 10.1097/01.grf.0000197501.06958.8b. PMID: 16456345.
Fabozzi G, Cimadomo D, Maggiulli R, et al. Which key performance indicators are most effective in evaluating and managing an in vitro fertilization laboratory? Fertility and Sterility. 2020 Jul;114(1):9-15. doi: 10.1016/j.fertnstert.2020.04.054. Epub 2020 Jun 9. PMID: 32532495.
Alpha Scientists In Reproductive Medicine. The Alpha consensus meeting on cryopreservation key performance indicators and benchmarks: proceedings of an expert meeting. Reproductive Biomedicine Online. 2012 Aug;25(2):146-167. doi: 10.1016/j.rbmo.2012.05.006. Epub 2012 May 29. PMID: 22727888.
ESHRE Clinic PI Working Group; Vlaisavljevic V, Apter S, Capalbo A, et al. The Maribor consensus: report of an expert meeting on the development of performance indicators for clinical practice in ART. Human Reproduction Open. 2021 Jul 3;2021(3):hoab022. doi: 10.1093/hropen/hoab022. PMID: 34250273; PMCID: PMC8254491.
Pirtea P, de Ziegler D, Poulain M, et al. Which key performance indicators are optimal to assess clinical management of assisted reproduction cycles? Fertility and Sterility. 2020 Jul;114(1):24-30. doi: 10.1016/j.fertnstert.2020.04.055. Epub 2020 Jun 10. PMID: 32532485.
Choucair, F., Younis, N., Hourani, A. The value of the modern embryologist to a successful IVF system: revisiting an age-old question. Middle East Fertility Society Journal, 26, 15 (2021). doi.org/10.1186/s43043-021-00061-8
Olofsson JI, Banker MR, Sjoblom LP. Quality management systems for your in vitro fertilization clinic's laboratory: Why bother? Journal of Human Reproductive Sciences. 2013 Jan;6(1):3-8. doi: 10.4103/0974-1208.112368. PMID: 23869142; PMCID: PMC3713573.
Vaiarelli A, Zacà C, Spadoni V, et al. Clinical and laboratory key performance indicators in IVF: A consensus between the Italian Society of Fertility and Sterility and Reproductive Medicine (SIFES-MR) and the Italian Society of Embryology, Reproduction and Research (SIERR). Journal of Assisted Reproduction and Genetics. 2023 Jun;40(6):1479-1494. doi: 10.1007/s10815-023-02792-1. Epub 2023 Apr 24. PMID: 37093443; PMCID: PMC10310668.
Working Group on the update of the ESHRE/ALPHA Istanbul Consensus; Coticchio G, Ahlström A, et al. The Istanbul consensus update: a revised ESHRE/ALPHA consensus on oocyte and embryo static and dynamic morphological assessment. Human Reproduction. 2025 Apr 28:deaf021. doi: 10.1093/humrep/deaf021. PMID: 40288770.
Coticchio, Giovanni et al. The Istanbul Consensus update: a revised ESHRE/ALPHA consensus on oocyte and embryo static and dynamic morphological assessment. Reproductive BioMedicine Online, 2025, Volume 50, Issue 6, 104955
Hammond ER, Morbeck DE. Tracking quality: can embryology key performance indicators be used to identify clinically relevant shifts in pregnancy rate? Human Reproduction. 2019 Jan 1;34(1):37-43. doi: 10.1093/humrep/dey349. Erratum in: Hum Reprod. 2019 Apr 1;34(4):780. PMID: 30517659.
Coticchio G, Behr B, Campbell A, et al. Fertility technologies and how to optimize laboratory performance to support the shortening of time to birth of a healthy singleton: a Delphi consensus. Journal of Assisted Reproduction and Genetics. 2021 May;38(5):1021-1043. doi: 10.1007/s10815-021-02077-5. Epub 2021 Feb 18. PMID: 33599923; PMCID: PMC8190195.
Zacà C, Coticchio G, Vigiliano V, et al. Fine-tuning IVF laboratory key performance indicators of the Vienna consensus according to female age. Journal of Assisted Reproduction and Genetics. 2022 Apr;39(4):945-952. doi: 10.1007/s10815-022-02468-2. Epub 2022 Mar 26. PMID: 35338418; PMCID: PMC9050984.
Bormann CL, Curchoe CL, Thirumalaraju P, et al. Deep learning early warning system for embryo culture conditions and embryologist performance in the ART laboratory. Journal of Assisted Reproduction and Genetics. 2021 Jul;38(7):1641-1646. doi: 10.1007/s10815-021-02198-x. Epub 2021 Apr 27. Erratum in: Journal of Assisted Reproduction and Genetics. 2021 May 14;: PMID: 33904010; PMCID: PMC8324654.
