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Abstract STUDY QUESTION What has the ESHRE programme ‘ESHRE Certification for Clinical Embryologists’ achieved after 10 years? SUMMARY ANSWER The post-exam analysis showed a pass rate of 60% for Clinical and 50% for Senior Clinical Embryologists and a high level of internal consistency of all exams, leading to a total of 773 certified Clinical and 493 Senior Clinical Embryologists over the decade. WHAT IS KNOWN ALREADY In an ESHRE survey on the educational and professional status of Clinical Embryology in Europe, it was found that education of laboratory personnel working in the field of assisted reproduction is highly variable between countries. In 2008, ESHRE introduced a programme, curriculum and certification in the field of Clinical Embryology. Knowledge gained by postgraduate study of recommended literature, following a clear curriculum, is verified by a written two-level exam for obtaining a certificate for Clinical (basic) or Senior Clinical (advanced) Embryologists. With a total of 1266 certificates awarded over a period of 10 years and recognition by the Union Européenne des Médecins Spécialistes and their Council for European Specialists Medical Assessment, the ESHRE Clinical Embryology exams have become an internationally recognized educational standard in the field of Clinical Embryology. STUDY DESIGN, SIZE, DURATION A retrospective analysis of all applications for ESHRE Clinical (2009–2018) and Senior Clinical Embryologist Certification (2008–2018) and exam results of the first decade was carried out by the Steering Committee for Clinical Embryologist Certification. PARTICIPANTS/MATERIALS, SETTING, METHODS A total of 2894 applications for ESHRE Certification for Clinical Embryologists and the results of 10 exams for the Clinical (1478 candidates) and 11 exams for Senior Clinical (987 candidates) levels were analysed. A detailed post-exam retrospective analysis was performed regarding difficulty, discrimination and reliability levels of 1600 multiple-choice questions (MCQs) with a single best answer among four options, from eight different curriculum topics (Basic cell biology, Genetics, Developmental biology, Female reproduction, Male reproduction, IVF laboratory, Cryopreservation and Laboratory management), representing the core theoretical knowledge of Clinical Embryology. Difficulty levels of the MCQs were subsequently compared regarding each topic and each yearly exam. The participation and success rates in the ESHRE Clinical Embryology exams were also assessed in terms of the educational and geographic backgrounds of candidates. MAIN RESULTS AND THE ROLE OF CHANCE Over the 10 years studied, the mean pass rate for the Clinical Embryologist exam was 60% (range 41–86%), and for the Senior Clinical Embryologist exam was 50% (range 34–81%). On average, 63% European candidates and 35% non-European candidates passed the Clinical Embryologist exam, while 52% European candidates and 31% non-European candidates passed the Senior Clinical Embryologist exam. The candidates’ educational level impacted on the success of the Clinical Embryologist exam but not of the Senior Clinical Embryologist exam. The mean difficulty indices by study topic showed that in the period of 10 years, there were no statistically significant differences between topics, for either the Clinical or Senior Clinical Embryologist exams. However, the overall exam difficulty varied between years. Reassuringly, the exam MCQ discrimination and reliability indices always showed a high level of internal consistency in all exams. LIMITATIONS, REASONS FOR CAUTION Some data from the initial ESHRE certification programme were not obtained electronically, in particular data for education, implying tables and figures reflect the specified valid data periods. Several countries exhibit different study profiles for those working in ART laboratories, such that laboratory technicians/technologists predominate in some countries, while in others only biologists and medical doctors are allowed to work with human embryos. Such differences could consequently affect the exam performance of candidates from specific countries. WIDER IMPLICATIONS OF THE FINDINGS The ESHRE exams on Clinical Embryology are the most widely, internationally accepted tests of knowledge in the rapidly growing area of human reproduction. Clinical Embryology is increasingly recognized as a specific discipline for scientific staff who are collaborating closely with clinicians in managing human infertility through medically assisted reproduction. The analysis of the first 10 years of application of a two-level exam for Clinical Embryology shows a consistent high quality and reliability of the exam and MCQs used. These results represent an important follow-up of the quality of the ESHRE Certification programme for Clinical Embryologists, and convincingly position Clinical Embryology in the wider group of health disciplines that are harmonized through professional bodies such as ESHRE and European Board & College of Obstetrics and Gynaecology. The exams provide a clear step towards the increasing professional recognition and establishment of Clinical Embryology within health systems at both European and international level. STUDY FUNDING/COMPETING INTEREST(S) No competing interest. All costs of the Steering Committee meetings were covered by ESHRE.

Study question How was the Logbook for the Nurses and Midwives Certification programme of the European Society of Human Reproduction and Embryology (ESHRE) developed? Summary answer The Logbook for the ESHRE Nurses and Midwives Certification programme, which questions 56 roles, was developed based on an extensive literature review and expert opinion. What is known already The ESHRE Executive Committee established the Nurses and Midwives Certification Committee (NMCC) in 2012. Since inception (2015), the certification programme has been delivered annually, with the exception of 2020 because of SARS-CoV-2. One-hundred-fourteen nurses/midwives have obtained ESHRE certification (passing rate=72%) and the programme is now accessible to nurses/midwives globally. The Certification program aims (i) to recognise the extended role of nurses/midwives delivering fertility care and (ii) to expand their theoretical background. The pre-requisites for certification are (i) being educated to a bachelor level of education and (ii) completing a practice based Logbook to demonstrate supervision of professional experience.  Study design, size, duration Between 2012 and 2014, the NMCC completed a systematic literature search for papers relating to clinical, non-clinical and extended roles of nurses and midwives in fertility settings. In addition, the NMCC invited a larger expert panel of European senior nurses and midwives to a meeting to discuss their needs and preferences regarding the certification programme and to survey the diverse roles performed by nurses and midwives in their country. Participants/materials, setting, methods The NMCC comprised four nurses/midwives, one clinical embryologist, and one medical doctor (both in advisory capacity). The Medline database was searched by entering a search string in PubMed combining (MeSH) terms related to reproductive medicine and nursing or midwifery. Opinion and empirical papers relating to roles of nurses/midwives in fertility settings were included. The surveyed expert panel included twelve nurses/midwives, representing Belgium, Denmark, Finland, France, Norway, Slovenia, Sweden, Turkey, Ukraine, and the United Kingdom. Main results and the role of chance A total of 49 papers, of which 24 empirical papers, were identified with the search string (n = 47) and snowball strategy (n = 2). The papers originated from 13 countries spread across Asia, Oceania, Europe, and North America. All twelve European senior nurses and midwives responded to the survey. Finally, 56 different roles were included in the Logbook. Forty-four roles were performed by nurses/midwives working in fertility settings according to the surveyed expert panel (n = 18), the literature (n = 8), or both the surveyed expert panel and literature (n = 18). An additional twelve observations of laboratory procedures were added by the NMCC. Substantial variation in roles and responsibilities existed across the countries from which the evidence originated. Whereas a considerate proportion of roles were performed in at least five countries (n = 16/56), a minority of roles were only performed by nurses/midwives in some countries (n = 7/56). Eight specialist roles (e.g. embryo transfer) were performed independently by nurses/midwives in some countries, whilst in other countries, nurses/midwives merely had an assisting role. In addition to completing the Logbook, participants were expected to write two ethical cases according to a guideline, testifying to their ability to reflect as a senior nurse/midwife. From 2015, the content of the Logbook was further developed. Limitations, reasons for caution This abstract relates to the development and content of the Logbook and not the curriculum/educational material required for the theoretical exam of the Nurses and Midwives Certification programme. The NMCC continuously improves the Logbook and elements have been added and removed since its creation. Wider implications of the findings The review and survey illustrated the variation in roles and responsibilities of nurses/midwives across the studied countries, further highlighting the opportunity for professional development within fertility care. Further research is required to elicit the experience of certified nurses/midwives with the programme and its impact on their professional and personal development. Trial registration number Not applicable

STUDY QUESTION Three years after the start of the ESHRE ART Centre Certification (ARTCC) programme, what is the current state of the system, in terms of the interest expressed in it and experiences during assessment of ART services? SUMMARY ANSWER As of 1st December 2021, 25 European ART centres have been involved in the various stages of certification and the most common recommendations from inspectors were the need for documented training, verification of competencies for all staff members, verification of laboratory and clinical performance indicators, implementation of a quality management system and avoidance of overusing ICSI and add-ons. WHAT IS KNOWN ALREADY European Union (EU) legislation has included ART activities in the EU Tissue and Cells Directives (EUTCDs). Following inspections by national EUTCD authorities, many details regarding documentation, laboratory environment, handling of reproductive cells and tissues, traceability, coding and patient testing have become standardized. However, the EUTCDs do not cover all ART-specific aspects. For this reason, the ARTCC was established to focus on peculiar areas, including relevant staff qualifications, training, continuing professional development, workload, equipment suitability, (non)-evidence-based laboratory and clinical methods used, treatment approaches according to ESHRE guidelines, recommendations and laboratory and clinical key performance indicators. STUDY DESIGN, SIZE, DURATION The paper reviews the state of the art of the ESHRE certification of ART centres for good clinical and laboratory practice over an initial 3-year period of operation, including the number of ART centres involved in the different stages of certification and the most common recommendations by inspectors. PARTICIPANTS/MATERIALS, SETTING, METHODS In 2016, the ARTCC working group began to establish a new ESHRE ARTCC programme. Since then, the working group has organised four preparatory courses and appointed 37 inspectors (19 clinicians, 17 embryologists and one paramedical). A tool to verify compliance with ESHRE recommendations for good laboratory and clinical practice was developed. The ARTCC has been open for applications since September 2018. In Step 1, the applicant enters basic information about the ART centre, staff and ART activities into the application platform. After review and approval, the applicant is given the opportunity to enter Step 2 and provide detailed online checklists on general, laboratory, clinical services and clinical outcomes. Two inspectors (one clinician and one embryologist) independently evaluate the submitted checklists. The condition to proceed to evaluation is a positive mean score (at least 66%) from each of the four checklists. In Step 3, a live site visit [or virtual owing to the coronavirus disease 2019 (COVID-19) pandemic] is organised and the inspectors prepare a final report with appropriate recommendations. The application may be rejected at any time if the criteria required to advance to the next stage are not met. The ARTCC programme is currently available for European countries listed in ESHRE internal rules, available on the ESHRE website. The certificate is valid for 3 years, after which an application for renewal can be submitted. MAIN RESULTS AND THE ROLE OF CHANCE Over a 3-year period (until 1st December 2021), 63 ART centres from 25 countries started applying through an online platform. So far, 38 applications did not progress owing to lack of completion of the initial application within a 1-year period or because applications came from non-European countries. Of the remaining 25 applications, eight centres have been inspected and seven centres have been certified. The most common recommendations given by inspectors to assessed centres were the need for documented training, verification of competencies, skills and continuing professional development for all staff members, verification of laboratory and clinical performance indicators and implementation of a quality management system. The inspectors identified some recurring areas of medically assisted reproduction that deviate from good practice: the overuse of ICSI, preimplantation genetic testing for aneuploidies, freeze-all and other add-ons. They often reported that the clinical outcomes could not be objectively assessed because of non-inclusion of the started cycles or the frequent use of freeze-all cycles. LIMITATIONS, REASONS FOR CAUTION No major modifications have been made to the application platform and checklists since the early stages of the certification programme. However, in this short time, quite a few changes in clinical practice have occurred, especially concerning the more frequent use of the “freeze-all” strategy. As a result, problems arose in the evaluation of clinical outcomes. In addition, because of the COVID-19 pandemic, site visits were substituted by the implementation of virtual visits. While this enabled the certification programme to continue, it is possible that certain critical details that would have been noticed during a traditional site visit may have been overlooked. WIDER IMPLICATIONS OF THE FINDINGS Regular monitoring of the observations of ARTCC inspectors and analysis of their reports is certainly useful to harmonise inspectors’ criteria in the assessment process and to identify chronic deficiencies in clinical and laboratory practice. Nonconformities can be addressed by ESHRE through guidelines and recommendations, as well as through discussion with EU institutions and competent authorities. STUDY FUNDING/COMPETING INTEREST(S) The ARTCC programme was developed and funded by ESHRE, covering expenses associated with the meetings. The Steering Committee members who are the authors of this paper did not receive payments for the completion of this study. The inspectors were remunerated for their work with an honorarium. The authors have no conflicts of interest to declare.