Purpose Infertility is increasing worldwide, and many couples seek IVF. Clinical management and laboratory work are fundamental in the IVF journey. Therefore, the definition of reliable key performance indicators (KPIs) based on clinical and laboratory parameters, is essential for internal quality control (IQC). Laboratory performance indicators have been identified and a first attempt to also determine clinical ones has been recently published. However, more detailed indicators are required. Methods An Italian group of experts in Reproductive Medicine from both public and private clinics on behalf of SIFES-MR and SIERR was established to define IVF indicators to monitor clinical performance. Results The working group built a consensus on a list of KPIs, performance indicators (PIs) and recommendation indicators (RIs). When deemed necessary, the reference population was stratified by woman age, response to ovarian stimulation and adoption of preimplantation genetic testing for aneuploidies (PGT-A). Each indicator was scored with a value from 1 to 5 and a weighted average formula – considering all the suggested parameters—was defined. This formula generates a center performance score, indicating low, average, good, or excellent performance. Conclusion This study is intended to provide KPIs, PIs and RIs that encompass several essential aspects of a modern IVF clinic, including quality control and constant monitoring of clinical and embryological features. These indicators could be used to assess the quality of each center with the aim of improving efficacy and efficiency in IVF.

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Study question Are the IVF laboratory KPIs of the Vienna consensus equally applicable to ICSI cycles performed with ejaculated or testicular sperm aspiration (TESA) samples? Summary answer In addition to standard ICSI cycles, the Vienna KPIs are largely applicable to TESA cases, except for 2PN fertilization and day 3 development rates. What is known already The ESHRE SIG Embryology and Alpha Scientists in Reproductive Medicine produced the first international consensus on a systematic set of IVF laboratory KPIs. These efficiency measures can reveal the possible impact of extrinsic factors, such as operator skills or culture media, on the IVF process. However, to control for intrinsic factors – i.e., specific gamete characteristics – the Vienna Consensus focused on a “reference population” as defined by female age ≤39years, exclusion of PGT cases and use of own fresh oocytes and ejaculated sperm. This leaves the relevance of the Vienna KPIs to other patient populations, including TESA cases, uncertain. Study design, size, duration This was a retrospective, single-center cohort analysis of 1678 ART ICSI cycles carried out between 2010 and 2022. Treatments involving TESA and ejaculated sperm were 105 and 1573, respectively. Participants/materials, setting, methods Inclusion criteria were indication for IVF/ICSI with own ejaculated or TESA spermatozoa and blastocyst culture of all embryos formed in each cohort. Oocyte donation and PGT cycles were not included. Ovarian stimulation was performed with either recombinant-FSH or hMG, combined with GnRH to prevent spontaneous LH surge. Fertilization of collected oocytes was achieved by ICSI. Main results and the role of chance Both maternal and paternal age were comparable between the two groups. In the TESA cases, 2PN rate was lower (N = 593/915, 64.8% versus N = 7276/10350, 70.3%; p < 0.01), while 1PN rate was higher (N = 32/915, 3.5% versus N = 246/10350, 2.4%; p = 0.04). Other fertilization and developmental rates were comparable: 3PN (N = 24/915, 2.6% versus N = 341/10350, 3.3%); microinjection damage (N = 52/915, 5.7% versus 632/10350, 6.1%); failed fertilization (N = 4/105, 3.8% versus N = 61/1573, 3.9%); cleavage (N = 579/593, 97.6% versus N = 7105/7276, 97.6%); day 2 development (N = 318/593, 53.6% versus N = 3887/7276, 53.4%); day 3 development (N = 248/593, 41.8% versus N = 3279/7276, 45.1%); total good blastocyst development rate (N = 147/361, 40.7% versus N = 1728/3944, 43.8%). Compared with the Vienna Consensus, all ICSI outcomes were within normal ranges as defined by competency and benchmark values, while in TESA cycles 2PN fertilization and day 3 development rates were slightly below the competency thresholds. Limitations, reasons for caution The study, especially because retrospective and with small sample size, requires external independent validation Wider implications of the findings The study confirms the robustness of the Vienna Consensus recommendations for the monitoring of the IVF laboratory performance, while highlighting the need for fine-tuning individual indicators in specific patient populations. Trial registration number not applicable