Published 19 July 2021
Almost four years after ESHRE and Alpha Scientists reported their indicators for laboratory performance in ART, a new consensus has now been published by an ESHRE working group on indicators of clinical performance in ART.
For the first time, ESHRE has defined a set of indicators for clinical performance in ART in a bid to improve outcomes, provide high-quality (safe) services for patients and improve education for practitioners.
The six objective measures, published in a July report in HROpen, relate to key clinical steps in the ART process, including ovarian stimulation, embryo transfer and pregnancy success.
Cycle cancellation rate before oocyte pick-up, rate of cycles with moderate/severe OHSS, and the proportion of mature oocytes at ICSI are on the list of performance indicators (PIs) recommended by an ESHRE working group, validated by a stakeholder survey and approved by the Executive Committee of ESHRE.
These clear definitions also include clinical and multiple pregnancy rates, and complication rate after OPU, which is defined in the report as the number of complications that require an additional medical intervention (apart from OHSS) over the number of OPUs.
The intention of the clinical PIs is to complement the success measurements for the laboratory stage (fresh IVF and ICSI cycles) of the ART cycle as defined in 2017 by the SIG Embryology and Alpha Scientists in Reproductive Medicine.(2) Together, it is hoped both sets of indicators will become an essential part of total quality management and practice in infertility treatment, which the authors of this new report describe as ‘a complex process’.
To reach consensus on clinical practice, the working group met in Maribor, Slovenia, over two days to assess published data in order to define PIs in an area where existing ones have been ‘scarce’ and agreement among clinicians lacking. The next step was to survey SIG Reproductive Endocrinology members to assess which of the working group’s statements (PIs, PI definitions and general statements) were acceptable. The survey was open for five weeks, with agreement reached overall for 84% of the statements (70% was the threshold for acceptance/rejection) based on 222 replies.
The resulting recommendations are outlined in a 14-page document which acknowledges the significant challenges in ART practice and performance, and the increasingly global nature of fertility treatment. The authors highlight how standardisation remains difficult, and infertility is often ‘not a definite diagnosis’ but somewhere on a scale ranging from ‘normal’ infertility to sometimes irreversible sterility.
Female age, BMI, concomitant disorders (eg, diabetes) which interact with ART/pregnancy, and risk of infectious disease transmission are among factors clinics should consider in their diagnosis and indications for treatment, as outlined in the report.
The consensus also notes increasing recognition of male factor, and, in addition to basic semen analysis based on WHO thresholds, suggests a full evaluation of the male partner in heterosexual couples with unexplained fertility/treated female factor and persistent infertility.
The report advises clinicians to consider four treatment decisions with regards to ART – burden, effectiveness, safety and costs. This is in an effort to ensure that decisions are made on a medical basis in order to reduce the disproportionate use of some procedures - such as ICSI. Similarly, the expected benefits of a treatment should be weighed against not only its risks/burden, but the ‘health of the subsequent pregnancy and child’.
So how closely should the recommendations be interpreted by clinicians and how often? The working group advises that the defined PIs should be calculated every six months/per 100 cycles, and every three months/per 50 cycles for clinical pregnancy rate and multiple PR. And for putting the PIs into practice, the approach should be ‘prudent’ and based on the specific clinical practice at each individual centre.
However, these current PIs are not set in stone. The report concludes that an update may be needed in future to define PIs at a local level given the dynamic nature of ART practice, especially with the ever growing use of elective single embryo transfer and freeze-all.
1. 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. HR Open 2021; doi:10.1093/hropen/hoab022
2. 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. HR Open 2017; 2; https://doi.org/10.1093/hropen/hox011
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