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Study question What are the characteristics of the psychological care and the emotional needs of couples undergoing ART treatment in Italy? Summary answer The presence of psychological support services in ART centers is poorly communicated to patients, with less than half being advised to take a pathway. What is known already Couples who decide to undergo ART treatment show significantly higher depression and shame scores, lower acceptance and self-compassion scores, greater reliance and avoidant coping strategies. Couples experience the procedure as source of stress, anxiety and pain, fluctuating between hope and despair, and all of this seem to negatively impact on treatment continuation and outcomes. A review of 25 studies using different psychological interventions (counseling, focused educational interventions and integrated educational programs) found positive effects on anxiety (61.5%), depression (38.4%) and infertility-related stress (100%) reduction. Several studies showed the effectiveness of psychological intervention in promoting pregnancy rates. Study design, size, duration The ART Italian National Register (National Health Institute) with the Department of Dynamic and Clinical Psychology and Health Studies (Sapienza University) proposed a national survey to 195 Italian ART centres and patient associations. Patient associations and the Medical Director of each centre were invited by e-mail to participate and to encourage all patients to fill a questionnaire made available on an on-line platform. Data collection was between March to October 2021. Participants/materials, setting, methods 324 ART patients completed an online questionnaire consisting of 19 closed-ended and 8 open-ended questions. In this abstract we focus on the closed-ended questions. The questionnaire was created ad hoc for the survey starting from a previous study on the characteristics of the services offered in Italian ART centres. Main results and the role of chance In 90% of cases women responded to the questionnaire, only 10% of responses were from men. On average, participants are 38 years old, married (60%), and have a bachelor's degree or post-graduate degree (59%). In half of the cases respondents are employed. In 68% of cases, participants performed ART treatment in centers with public service. Most of the respondents are facing their first or second ART cycle. They share their infertility condition with family and friends, and in 60% of cases they have been informed of the presence of the psychological service, mainly from gynecologists and through informed consent. Only in 31% of cases patients were invited to undertake psychological counseling, strongly recommended to only 8% of them. In fact, 65% of respondents never had a meeting with the psychologist during ART treatment. Those who resorted to counseling had mainly couple (45%) and individual (31.3%) meetings. Participants did not know the cost of counseling, would prefer it to be included in the cost of ART treatment, and would like it to be available throughout treatment The main emotions felt during ART treatment are sadness, fear and anger, those attributed to the partner are the same but joy also appears. Limitations, reasons for caution Firstly the limited sample size, mainly related to the ability of ART center staff to spread the initiative among patients. The low response from male partners, that could be related to their rare presence in ART centers, as the medical treatment is mainly targeted to women. Wider implications of the findings In conclusion, the results show that psychological services in Italian ART centers are not yet fully operational and integrated in the ART procedure. All this highlights the importance of further investigations with the aim of sharing information to establish common protocols for psychological interventions in ART centres. Trial registration number Not applicable

Study question Could factors inherent to individual centers, related to local clinical or laboratory variables, play a role in the increased incidence of monozygotic twins in IVF? Summary answer The rate of MZT did not significantly vary among IVF centers What is known already The risk of monozygotic twins (MZT) is increased in couples undergoing in vitro fertilization (IVF). Several systematic reviews have investigated the possible determinants linked to IVF, but results obtained have been inconclusive. Associations have been identified with the prolonged culture at blastocyst stage and young female age. Conventional IVF compared to ICSI, and assisted hatching emerged as possible additional risk factors, but evidence is controversial. Meta-analyses, however, cannot provide robust evidence because of the difficulty in performing multivariate analyses. Moreover, available investigations were retrospective and involved relatively small sample sizes hampering the quality of the collected data. Study design, size, duration This is a multicenter retrospective cohort study using the Italian ART National Registry database and involving the Centers reporting data from individual IVF cycles from 2015 to 2019. Eighteen IVF centers were included with a total of 87,076 IVF cycles reported during the study period. The primary aim of the study was to investigate whether the incidence of MZT differed among centers. Participants/materials, setting, methods Only single embryo transfer cycles were considered. Women who had sex-discordant twin deliveries were excluded. MZT rate was calculated as the number of multiple pregnancies out of the total number of clinical pregnancies. A binomial distribution model was used to determine the 95% CI of the frequency of MZT. The rates among centers were deemed heterogeneous if the 95% CI in at least one center did not include the mean MZT rate. Main results and the role of chance Ten centers reported data from 2015 to 2019, eight from 2017 to 2019. An analysis of the main characteristics of the centers revealed considerable variability. The total number of clinical pregnancies fulfilling our inclusion criteria were 10,440. Of these, 7 were found to be twin pregnancies with discordant gender and were excluded, leaving 10,433 for data analyses. The number of cases included per center varied between 11 and 2,823. Overall, 162 pregnancies were found to be multiple: 48 ended in a miscarriage, 28 spontaneously reduced to singletons and 86 women delivered two or more newborns. The vast majority were twins (n = 160), one was triplet, and one was quadruplet. Considering the denominator of 10,433 pregnancies, the rate of MZT was thus 1.5% (95%CI: 1.3 - 1.8%). The MZT rate among centers varied between 0% (95%CI: 0.0 - 25.9%) and 3.2% (95%CI: 1.3 - 8.1%). All the 95%CIs of the rates of MZT include the 1.5% common rate, thus rejecting the hypothesis that this incidence significantly differed among centers. Spearman correlations between the rate of MZT and variables associated with individual center policies could not identify any significant association. Even when restricting the analyses only to the largest centers, no association emerged. Limitations, reasons for caution Our study was limited by its retrospective nature. Furthermore, some centers provided less than 100 cases for data analysis and were therefore poorly informative. External confirmation from larger registries is therefore required. Wider implications of the findings This study provides evidences that the rate of MZT did not differ among IVF centers. Furthermore, no clinical and laboratory variables inherent to individual centers were identified in the determinism of IVF-associated MZT. Further studies are needed to identify the causes of increased risk of MZT in IVF practice. Trial registration number not applicable

Study question Evaluate the impact of restrictive measures, implemented to contain the spread SARS-CoV-2, on ART activity in Italy during 2020. Summary answer Due to periods of suspension of certain medical procedures in 2020, ART activity has undergone a substantial reduction. What is known already Since the end of February 2020, the spread of SARS-CoV-2 has taken a dramatic toll, especially in Northern Italy. In order to ensure that the majority of National Health System resources were employed to control the epidemic, non-urgent medical procedures such as ART treatments, were suspended or postponed by a Government Decree issued on March 9, 2020. Only fertility preservation in cancer patients continued as these procedures could not be deferred. The first suspension of activity lasted about two months. Then, throughout 2020 many ART centers were forced to suspend their activity again because of flairs in SARS-CoV-2 infection rates. Study design, size, duration The Italian Assisted Reproductive Technology Register (IARTR) retrospectively analyzed ART cycles applied in Italy in 2020 (67,928 ART cycles performed on 57,423 patients). The 2020 ART cycles were compared to those applied in 2019 (82,476 ART cycles performed on 67,633 patients). Data collection was organized yearly in two different time frames: the first regards the activity conducted during the year until pregnancy and the second regards pregnancy outcomes. Participants/materials, setting, methods A total of 205 ART clinics have sent data to the IARTR in 2019 and/or 2020. Among those clinics 54.1% were private, 37.1% were public and 8.9% were private covered by NHS. Records were securely kept in the IARTR archive. The analysis has been performed utilizing SPSS 27.0 Main results and the role of chance In 2020, the number of total ART cycles reported was 67,928 including 38,728 homologous fresh cycles (Fresh), 1,099 frozen/thawed oocytes (FO), 19,314 frozen embryo (FER) and 8,787 ART donation cycles. In 2019, 82,476 cycles were reported, including 50,324 Fresh, 1,361 FO, 21,796 FER and 8,995 gametes donation. In 2020, there have been 14,548 less ART cycles than in 2019, equivalent to a 17.6% of reduction in overall activity. However, the reduction was not homogeneous for all ART techniques, in particular there was a reduction of -23% in fresh cycles, of -11.4% in FER, of -19.3% in FO and of -2.3% for gametes donation. This overall reduction led to 3,325 fewer pregnancies. The reduction of treatment cycles observed in 2020 brings to 2,119 fewer deliveries (-18.0%) and to 2,539 fewer live born babies (-19.8%) compared to 2019. The percentage reduction of births is not homogeneous for the different ART techniques, ranging from -0.3% in donation cycles to -36.9% in fresh cycles. Lastly, during 2020 a reduction in multiple births (-2.1%) has been observed. Limitations, reasons for caution Since the national ART Register collect only summary data more deep analysis could not be performed. For some ART techniques the reduction may have been greater (i.e. donation cycles) if considering the growing trends of previous years. Wider implications of the findings Covid-19 pandemic has had a strong impact on Italian Health System. ART procedures suffered a reduction of availability. Since Italy has the lowest birth rate in Europe and ART plays an important role answering to the need of infertile couples, Government should support access to these treatments with dedicated actions. Trial registration number not applicable

Study question What is the point of view of physicians, psychologists and patients on the characteristics of the psychological assistance offered by Italian ART centres? Summary answer Physicians, psychologists and patients alike affirm the importance of specialised psychological support during ART treatment What is known already The European Society of Human Reproduction and Embryology (ESHRE) has produced specific recommendations, establishing that all staff members should share the responsibility related to patients’ psychological wellbeing through their treatments. Moreover, when patients show increased risk of negative consequences some specialized services, as psychological counseling or psychotherapy, should be provided. In Italy, the Law 40/2004 regulates ART treatment and also provides the “Guidelines for the application of Assisted Reproductive Technology” (2008, 2015). According to this law, psychological support for women and couples undergoing ART procedures at any step of medical treatment (before, during, after the treatment) should be routinely included. Study design, size, duration To explore opinions on the characteristics of the psychological support service in ART centres: An online questionnaire was sent to the physicians in charge of 341 ART centres. 5 focus groups with psychologists working in ART centres were carried out. An online questionnaire for patients was sent to 195 centres and 8 patient associations. The surveys were conducted over a period from January 2020 to October 2021. Participants/materials, setting, methods Physicians from 113 centres (37%) responded to questionnaires composed of 20 closed-ended and 6 open-ended questions; 28 psychologists working in ART centres in 3 italian regions participated in focus groups with 3 open-ended questions; and 324 patients responded to questionnaires composed of 19 closed-ended and 8 open-ended questions. The questionnaires were created ad hoc for the surveys starting from the characteristics of the services offered in Italian ART centers. Main results and the role of chance Physicians affirm the importance of the psychologist in the ART centre to support their work: managing couples’ emotional difficulties; improving couples’ mood; and reducing couples’ stress (9% of answers). They also ask for an effective psychological intervention protocol to adopt. Concerning the characteristics of psychological services, physicians do not identify priority areas of intervention, but they admit the usefulness of psychological intervention throughout the treatment. Most physicians admit the utility of psychological counseling as defined by the 2015 Guidelines. Psychologists would like more recognition of their function and they affirm the positive contribution of networking among ART psychologists, believing that specific training is needed to work in the field. The psychologists find that multidisciplinary work in the team is functional and improves the quality of service offered in this field. Patients say that ongoing psychological support throughout the treatment could be helpful for them. They believe that psychologists should have specific training in ART and they would like the cost of psychological support to be included in ART treatment. They argue that psychological support should help their relationship with physicians. Despite this, the psychologist is a stable professional figure in only half of the responding ART Centres (47%). Limitations, reasons for caution Physicians’ opinions are based on a 37% response rate from ART centres and cannot be considered conclusive. The 5 focus groups were conducted with psychologists working in ART centres located in only three Italian regions. There were few responses from male patients. Wider implications of the findings In conclusion, despite the scarce presence of psychological support in ART centres, physicians, psychologists and patients believe that it would be mportant throughout ART treatment. This highlights the importance of further investigation with the aim of sharing information to establish common protocols for psychological interventions in italian ART centres. Trial registration number not applicable

STUDY QUESTION Are there any changes in the treatments involving ART and IUI initiated in Europe during 2013 compared with previous years? SUMMARY ANSWER An increase in the overall number of ART cycles resulting from a higher number of countries reporting data was evident, the pregnancy rates (PRs) in 2013 remained stable compared with those reported in 2012, the number of transfers with multiple embryos (3+) was lower than ever before yet the multiple delivery rates (DRs) remained unchanged, and IUI activity and success rates were similar to those of last years. WHAT IS KNOWN ALREADY Since 1997, ART data in Europe have been collected and reported in 16 manuscripts, published in Human Reproduction. STUDY DESIGN, SIZE, DURATION Retrospective data collection of European ART data by the European IVF-monitoring Consortium for ESHRE. Data for cycles between 1 January and 31 December 2013 were collected from National Registers, when existing, or on a voluntary basis by personal information. PARTICIPANTS/MATERIALS, SETTINGS, METHODS From 38 countries (+4 compared with 2012), 1169 clinics reported 686 271 treatment cycles including 144 299 of IVF, 330 367 of ICSI, 154 712 of frozen embryo replacement (FER), 40 244 of egg donation (ED), 247 of IVM, 9791 of PGD/PGS and 6611 of frozen oocyte replacements. European data on intrauterine insemination using husband/partner's semen (IUI-H) and donor semen (IUI-D) were reported from 1095 IUI labs in 22 countries. A total of 175 467 IUI-H and 43 785 IUI-D cycles were included. MAIN RESULTS AND THE ROLE OF CHANCE In 17 countries where all clinics reported to their ART register, a total of 374 177 ART cycles were performed in a population of around 310 million inhabitants, corresponding to 1175 cycles per million inhabitants (range, 235-2703 cycles per million inhabitants). For all IVF cycles, the clinical PRs per aspiration and per transfer were stable with 29.6% (29.4% in 2012) and 34.5% (33.8% in 2012), respectively. For ICSI, the corresponding rates also were stable with 27.8% (27.8% in 2012) and 32.9% (32.3% in 2012). In FER-cycles, the PR per thawing/warming increased to 27.0% (23.1% in 2012). In ED cycles, the PR per fresh transfer increased to 49.8% (48.4% in 2012), to 38.5% (35.9% in 2012) per thawed transfer, and to 46.4% for transfers after FOR (45.1% in 2012). The DRs after IUI remained stable at 8.6% (8.5% in 2012) after IUI-H and was slightly lower after IUI-D (11.1% versus 12.0% in 2012). In IVF and ICSI cycles, 1, 2, 3 and 4+ embryos were transferred in 31.4, 56.3, 11.5, and 1.0% of the cycles, respectively (corresponding numbers were 30.2, 55.4, 13.3 and 1.1% in 2012). The proportions of singleton, twin and triplet deliveries after IVF and ICSI (added together) were 82., 17.5 and 0.5%, respectively, resulting in a total multiple DR of 18.0% compared to 17.9% in 2012. In FER-cycles, the multiple DR was 12.8% (12.5% twins and 0.3% triplets), nearly the same as in 2012 (12.5, 12.2 and 0.3% respectively). Twin and triplet DRs associated with IUI cycles were 9.5%/0.6% and 7.5%/0.3%, following treatment with husband/donor semen, respectively. LIMITATIONS, REASONS FOR CAUTION The method of reporting varies among countries, and registers from a number of countries have been unable to provide some of the relevant data such as initiated cycles and deliveries. As long as data are incomplete and generated through different methods of collection, the results should be interpreted with caution. WIDER IMPLICATIONS OF THE FINDINGS The 17th ESHRE report on ART shows a continuing expansion of the number of treatment cycles in Europe, with more than 685 000 cycles reported in 2013 and an increasing contribution to birth rate in many countries. However, the need to improve and standardize the national registries, and to establish validation methodologies, remains manifest. STUDY FUNDING/COMPETING INTEREST(S) The study has no external funding; all costs are covered by ESHRE. There are no competing interests.