Women's perceptions of fertility assessment and counselling 6 years after attending a Fertility Assessment and Counselling clinic in Denmark.

What are women's perceptions and experience of fertility assessment and counselling 6 years after attending a Fertility Assessment and Counselling (FAC) clinic in Denmark? Women viewed the personalized fertility knowledge and advice they received as important aids to decision-making and they felt the benefits outweighed the risks of receiving personalized fertility information. Many young people wish to become parents in the future. However, research demonstrates there is a gap in women's and men's knowledge of fertility and suggests they may be making fertility decisions based on inaccurate information. Experts have called for the development of interventions to increase fertility awareness so that men and women can make informed fertility decisions and achieve their family-building goals. Since 2011, the FAC clinic in Copenhagen, Denmark has provided personalized fertility assessment and guidance based on clinical examination and evaluation of individual risk factors. Available qualitative research showed that attending the FAC clinic increased fertility awareness and knowledge and was experienced as a catalyst for change (e.g. starting to conceive, pursuing fertility treatment, ending a relationship) in women 1-year post-consultation. The study was a 6-year follow-up qualitative study of 24 women who attended the FAC clinic between January and June 2012. All women were interviewed during a 2-month period from February to March 2018 at Rigshospitalet, their home or office, in Copenhagen, Denmark. Interviews were held in English and ranged between 60 and 94 min (mean 73 min). Invitations to participate in an interview-based follow-up study were sent to 141 women who attended the FAC clinic in 2012. In total, 95 women read the invitation, 35 confirmed interest in participating and 16 declined to participate. Twenty-five interviews were booked and 24 interviews held. Interviews followed a semi-structured format regarding reasons for attending the FAC clinic, if/how their needs were met, and perceptions of fertility assessment and counselling. Data were analysed using thematic analysis. At the follow-up interview, women were on average 39.5 years old. Ten were currently single or dating and 14 were married/cohabiting. All were childless when they attended the FAC clinic. At the follow-up interview, 21 women were parents (14 women with one child; 6 with two children; 1 with three children) and the remaining three women intended to have children in the future. The most common reason for originally attending the FAC clinic was to determine how long they could delay childbearing. Most of the women now believed their needs for attending had been met. Those who were dissatisfied cited a desire for more exact ('concrete') information as to their remaining years of fertility, although acknowledged that this was likely not realistic. Women stated that they had felt reassured as to their fertility status after attending the FAC clinic whilst receiving the message that they could not delay childbearing 'too long'. Women viewed personalized fertility knowledge as an important aid to decision-making but cautioned about developing a false sense of security about their fertility and chance of conceiving in the future based on the results. Although women were generally satisfied with their experience, they wished for more time to discuss options and to receive additional guidance after their initial meeting at the FAC clinic. Participants were from a group of Danish women attending the FAC clinic and interviews were conducted in English, which means they are not representative of all reproductive-aged women. Nevertheless, the study group included a broad spectrum of women who achieved parenthood through different means (heterosexual/lesbian relationship, single parent with donor, co-parent) with various family sizes, and women who were currently childless. Our study provides support for an individualized approach to fertility education, assessment and counselling provided at a time when the information is relevant to the individual and their current fertility decision-making. The findings suggest that although satisfied with their visit to the FAC clinic, the women wished for more information and guidance after this visit, suggesting that the current intervention may need to be expanded or new interventions developed to meet these additional needs. E.K. was funded by an ESHRE Travel/Training grant by ReproUnion, co-financed by the European Union, Interreg V OKS. J.B. reports that the risk evaluation form used at the Fertility Assessment Clinic was inspired by the Fertility Status Awareness Tool FertiSTAT that was developed at Cardiff University for self-assessment of reproductive risk. J.B. also reports personal fees from Merck KGaA, Merck AB, Theramex, Ferring Pharmaceuticals A/S and a research grant from Merck Serono Ltd outside the submitted work. A.N.A. has received personal fees from both Merck Pharmaceuticals and Ferring and grants from Roche Diagnostics outside the submitted work. The other authors report no conflicts of interest.

Koert E ，Sylvest R ，Vittrup I ，Hvidman HW ，Birch Petersen K ，Boivin J ，Nyboe Andersen A ，Schmidt L ... -  《-》

Patient experiences of fertility clinic closure during the COVID-19 pandemic: appraisals, coping and emotions.

What are appraisals, coping strategies and emotional reactions of patients to coronavirus disease 2019 (COVID-19) fertility clinic closures? Clinic closure was appraised as stressful due to uncertainty and threat to the attainability of the parenthood goal but patients were able to cope using strategies that fit the uncertainty of the situation. Psychological research on COVID-19 suggests that people are more anxious than historical norms and moderately to extremely upset about fertility treatment cancellation owing to COVID-19. The study was of cross-sectional design, comprising a mixed-methods, English language, anonymous, online survey posted from April 9 to 21 to social media. Eligibility criteria were being affected by COVID-19 fertility clinic closure, 18 years of age or older and able to complete the survey in English. In total, 946 people clicked on the survey link, 76 did not consent, 420 started but did not complete the survey and 450 completed (48% completion, 446 women, four men). Overall 74.7% (n = 336) of respondents were residents in the UK with an average age of 33.6 years (SD = 4.4) and average years trying to conceive, 3.5 years (SD = 2.22). The survey comprised quantitative questions about the intensity of cognitive appraisals and emotions about clinic closure, and ability to cope with clinic closure. Open-text questions covered their understanding of COVID-19 and its effect on reproductive health and fertility plans, concerns and perceived benefits of clinic closure, and knowledge about closure. Sociodemographic information was collected. Descriptive and inferential statistics were used on quantitative data. Thematic qualitative analysis (inductive coding) was performed on the textual data from each question. Deductive coding grouped themes from each question into meta-themes related to cognitive stress and coping theory. Most patients (81.6%, n = 367) had tests or treatments postponed, with these being self (41.3%, n = 186) or publicly (46.4%, n = 209) funded. Patients appraised fertility clinic closure as having potential for a more negative than positive impact on their lives, and to be very or extremely uncontrollable and stressful (P ≤ 0.001). Most reported a slight to moderate ability to cope with closure. Data saturation was achieved with all open-text questions, with 33 broad themes identified and four meta-themes linked to components of the cognitive stress and coping theory. First, participants understood clinic closure was precautionary due to unknown effects of COVID-19 but some felt clinic closure was unfair relative to advice about getting pregnant given to the public. Second, closure was appraised as a threat to attainability of the parenthood goal largely due to uncertainty of the situation (e.g. re-opening, effect of delay) and intensification of pre-existing hardships of fertility problems (e.g. long time waiting for treatment, history of failed treatment). Third, closure taxed personal coping resources but most were able to cope using thought-management (e.g. distraction, focusing on positives), getting mentally and physically fit for next treatments, strengthening their social network, and keeping up-to-date. Finally, participants reported more negative than positive emotions (P ≤ 0.001) and, almost all participants reported stress, worry and frustration at the situation, while some expressed anger and resentment at the unfairness of the situation. Overall, 11.8% were not at all able to cope, with reports of intense feelings of hopelessness and deteriorating well-being and mental health. The survey captures patient reactions at a specific point in time, during lockdown and before clinics announced re-opening. Participants were self-selected (e.g. UK residents, women, 48% starting but not completing the survey), which may affect generalisability. Fertility stakeholders (e.g. clinics, patient support groups, regulators, professional societies) need to work together to address the great uncertainty from COVID-19. This goal can be met proactively by setting up transparent processes for COVID-19 eventualities and signposting to information and coping resources. Future psychological research priorities should be on identifying patients at risk of distress with standardised measures and developing digital technologies appropriate for the realities of fertility care under COVID-19. University funded research. Outside of the submitted work, Prof. J.B. reports personal fees from Merck KGaA, Merck AB, Theramex, Ferring Pharmaceuticals A/S; grants from Merck Serono Ltd; and that she is co-developer of the Fertility Quality of Life (FertiQoL) and MediEmo apps. Outside of the submitted work, Dr R.M. reports personal or consultancy fees from Manchester Fertility, Gedeon Richter, Ferring and Merck. Outside of the submitted work, Dr S.G. reports consultancy fees from Ferring Pharmaceuticals A/S, Access Fertility and SONA-Pharm LLC, and grants from Merck Serono Ltd. The other authors declare no conflicts of interest. N/A.

Boivin J ，Harrison C ，Mathur R ，Burns G ，Pericleous-Smith A ，Gameiro S ... -  《-》

Evidence-based guideline: unexplained infertility†.

What is the recommended management for couples presenting with unexplained infertility (UI), based on the best available evidence in the literature? The evidence-based guideline on UI makes 52 recommendations on the definition, diagnosis, and treatment of UI. UI is diagnosed in the absence of any abnormalities of the female and male reproductive systems after 'standard' investigations. However, a consensual standardization of the diagnostic work-up is still lacking. The management of UI is traditionally empirical. The efficacy, safety, costs, and risks of treatment options have not been subjected to robust evaluation. The guideline was developed according to the structured methodology for ESHRE guidelines. Following formulation of key questions by a group of experts, literature searches, and assessments were undertaken. Papers written in English and published up to 24 October 2022 were evaluated. Based on the available evidence, recommendations were formulated and discussed until consensus was reached within the guideline development group (GDG). Following stakeholder review of an initial draft, the final version was approved by the GDG and the ESHRE Executive Committee. This guideline aims to help clinicians provide the best care for couples with UI. As UI is a diagnosis of exclusion, the guideline outlined the basic diagnostic procedures that couples should/could undergo during an infertility work-up, and explored the need for additional tests. The first-line treatment for couples with UI was deemed to be IUI in combination with ovarian stimulation. The place of additional and alternative options for treatment of UI was also evaluated. The GDG made 52 recommendations on diagnosis and treatment for couples with UI. The GDG formulated 40 evidence-based recommendations-of which 29 were formulated as strong recommendations and 11 as weak-10 good practice points and two research only recommendations. Of the evidence-based recommendations, none were supported by high-quality evidence, one by moderate-quality evidence, nine by low-quality evidence, and 31 by very low-quality evidence. To support future research in UI, a list of research recommendations was provided. Most additional diagnostic tests and interventions in couples with UI have not been subjected to robust evaluation. For a large proportion of these tests and treatments, evidence was very limited and of very low quality. More evidence is required, and the results of future studies may result in the current recommendations being revised. The guideline provides clinicians with clear advice on best practice in the care of couples with UI, based on the best evidence currently available. In addition, a list of research recommendations is provided to stimulate further studies in the field. The full guideline and a patient leaflet are available in www.eshre.eu/guideline/UI. The guideline was developed by ESHRE, who funded the guideline meetings, literature searches, and dissemination of the guideline in collaboration with the Monash University led Australian NHMRC Centre of Research Excellence in Women's Health in Reproductive Life (CREWHIRL). The guideline group members did not receive any financial incentives; all work was provided voluntarily. D.R. reports honoraria from IBSA and Novo Nordisk. B.A. reports speakers' fees from Merck, Gedeon Richter, Organon and Intas Pharma; is part of the advisory board for Organon Turkey and president of the Turkish Society of Reproductive Medicine. S.B. reports speakers' fees from Merck, Organon, Ferring, the Ostetric and Gynaecological Society of Singapore and the Taiwanese Society for Reproductive Medicine; editor and contributing author, Reproductive Medicine for the MRCOG, Cambridge University Press; is part of the METAFOR and CAPE trials data monitoring committee. E.B. reports research grants from Roche diagnostics, Gedeon Richter and IBSA; speaker's fees from Merck, Ferring, MSD, Roche Diagnostics, Gedeon Richter, IBSA; E.B. is also a part of an Advisory Board of Ferring Pharmaceuticals, MSD, Roche Diagnostics, IBSA, Merck, Abbott and Gedeon Richter. M.M. reports consulting fees from Mojo Fertility Ltd. R.J.N. reports research grant from Australian National Health and Medical Research Council (NHMRC); consulting fees from Flinders Fertility Adelaide, VinMec Hospital Hanoi Vietnam; speaker's fees from Merck Australia, Cadilla Pharma India, Ferring Australia; chair clinical advisory committee Westmead Fertility and research institute MyDuc Hospital Vietnam. T.P. is a part of the Research Council of Finland and reports research grants from Roche Diagnostics, Novo Nordics and Sigrid Juselius foundation; consulting fees from Roche Diagnostics and organon; speaker's fees from Gedeon Richter, Roche, Exeltis, Organon, Ferring and Korento patient organization; is a part of NFOG, AE-PCOS society and several Finnish associations. S.S.R. reports research grants from Roche Diagnostics, Organon, Theramex; consulting fees from Ferring Pharmaceuticals, MSD and Organon; speaker's fees from Ferring Pharmaceuticals, MSD/Organon, Besins, Theramex, Gedeon Richter; travel support from Gedeon Richter; S.S.R. is part of the Data Safety Monitoring Board of TTRANSPORT and deputy of the ESHRE Special Interest Group on Safety and Quality in ART; stock or stock options from IVI Lisboa, Clínica de Reprodução assistida Lda; equipment/medical writing/gifts from Roche Diagnostics and Ferring Pharmaceuticals. S.K.S. reports speakers' fees from Merck, Ferring, MSD, Pharmasure. HRV reports consulting and travel fees from Ferring Pharmaceuticals. The other authors have nothing to disclose. This guideline represents the views of ESHRE, which were achieved after careful consideration of the scientific evidence available at the time of preparation. In the absence of scientific evidence on certain aspects, a consensus between the relevant ESHRE stakeholders has been obtained. Adherence to these clinical practice guidelines does not guarantee a successful or specific outcome, nor does it establish a standard of care. Clinical practice guidelines do not replace the need for application of clinical judgment to each individual presentation, nor variations based on locality and facility type. ESHRE makes no warranty, express or implied, regarding the clinical practice guidelines and specifically excludes any warranties of merchantability and fitness for a particular use or purpose. (Full disclaimer available at www.eshre.eu/guidelines.).

Guideline Group on Unexplained Infertility ，Romualdi D ，Ata B ，Bhattacharya S ，Bosch E ，Costello M ，Gersak K ，Homburg R ，Mincheva M ，Norman RJ ，Piltonen T ，Dos Santos-Ribeiro S ，Scicluna D ，Somers S ，Sunkara SK ，Verhoeve HR ，Le Clef N ... -  《-》

Qualitative evaluation of the acceptability and feasibility among healthcare professionals and patients of an ART multi-cycle treatment planning and continuation intervention prototype.

Is it possible to design an ART Treatment Planning and Continuation Intervention (TPCI) that is considered acceptable and feasible to patients and healthcare professionals (HCPs)? HCPs and patients responded positively to the TPCI prototype and perceived it as an acceptable intervention to support patients to stay engaged with planned treatment, but some concerns were raised about the feasibility of using it in practice. People discontinue ART due to its psychological burden. Digital tools to support people undergoing ART are available but typically focus only on practical support rather than psychological support. Research about treatment continuation and multi-cycle planning indicates that cognitive factors (expectations, intentions, efficacy beliefs) should be targets of interventions designed to help patients engage with and continue treatment to meet their personal treatment plans and goals. However, it is not known whether this form of psychological support would be acceptable for HCPs and patients or feasible to implement in practice. Qualitative cognitive interviews with HCPs and patients (May 2021). Patients were eligible if they had had a consultation to start a first/repeat stimulated IVF/ICSI cycle in the 8 weeks prior to recruitment, were aged 18 or older (upper age limit of 42 years for women) and fluent in English. Eligible HCPs were those employed by a fertility clinic who were responsible for delivering treatment planning consultations to patients. HCPs and patients were asked to think aloud while being exposed to and exploring the TPCI in one-to-one online cognitive interviews. The TPCI was designed to reduce treatment discontinuation via cognitive factors namely formation and maintenance of multi-cycle ART intentions and efficiency of decision-making during treatment, and continuation of treatment after an unsuccessful cycle (when recommended). To impact cognitive factors the TPCI comprised of two components: an expectation management and reasoning checklist for HCPs to use during planning consultations (TPCI Checklist) and a multi-feature cognitive support mobile application (TPCI App) for patients to use prior to and during treatment. After participants thought aloud while being exposed to the TPCI prototype (both components) they were asked open questions concerning their perceptions of the core components and activities on eight acceptability dimensions (e.g. acceptability, demand, integration). Interviews lasted between 40 and 90 min, were recorded, transcribed verbatim and analysed using thematic analysis. Thirteen HCPs and 13 patients participated in 25 online interviews. Thematic analysis using inductive and deductive coding generated 180 codes, grouped into 22 categories and synthesized into 9 themes. The themes showed that HCPs and patients provided positive feedback about the TPCI, perceiving it as a needed, acceptable and potentially effective way to forewarn patients of the possible need for multiple cycles, to provide patients with a sense of patient-clinic collaboration and support, and to bolster treatment intentions, all of which were perceived to contribute to reduced treatment discontinuation. HCPs perceived implementation of the TPCI Checklist to be challenging in its current length due to time pressures and clinic workload. Suggestions for enhancing the TPCI Checklist and App were provided, but none required critical changes to its core components or activities. All patients were women recruited from social media websites, mainly associated with patient support groups, who may be highly committed to their fertility treatment. HCPs were predominantly from private fertility clinics. The findings suggest there is demand for digital support geared towards motivational aspects of undergoing ART. The TPCI is an acceptable support tool to meet that need according to HCPs responsible for delivering planning consultations and patients undergoing fertility treatment. Future research is needed to develop the prototype and examine the feasibility of implementation of the TPCI in clinics. This research was financially supported by Merck Serono Ltd, an affiliate of Merck KGaA, Darmstadt, Germany. 'Merck KGaA, Darmstadt, Germany reviewed the manuscript for medical accuracy only before journal submission. The authors are fully responsible for the content of this manuscript, and the views and opinions described in the publication reflect solely those of the authors' J.B. reports personal fees from Merck KGaA, Darmstadt, Germany, Merck AB an affiliate of Merck KGaA, Darmstadt Germany, Theramex, Organon JJC, Ferring Pharmaceuticals A/S, research grant from Merck Serono Ltd, grants from ESHRE outside the submitted work and that she is co-developer of Fertility Quality of Life (FertiQoL) and MediEmo app. S.G. reports consultancy fees from TMRW Life Sciences and Ferring Pharmaceuticals A/S, speaker fees from Access Fertility, SONA-Pharm LLC, Meridiano Congress International and Gedeon Richter. C.H. declares no conflicts of interest. N/A.

Harrison C ，Gameiro S ，Boivin J 《-》

Patient willingness, preferences and decision-making about planning for three complete cycles of IVF/ICSI treatment.

What is willingness, preference and decision-making about planning for the possibility of needing multiple cycles of IVF/ICSI treatment among patients consulting for a first or repeat stimulated IVF/ICSI cycle? The majority of patients seem to value the opportunity to plan for multiple cycles of treatment while acknowledging both possible challenges and benefits of doing so and decisions that might need to be made in advance. Patients have strong intentions to do treatment to achieve pregnancy and approximately 48-54% continue treatment when confronted with a failed cycle, undergoing at least three complete cycles of treatment. However, there is inconsistency between this apparent willingness to do multiple cycles of treatment and the way treatment is currently planned on a cycle-by-cycle basis with patients. The study was of cross-sectional design, comprising a mixed-methods English online survey posted between November 2019 and March 2020. Eligibility criteria were being a patient who had had a consultation to start a stimulated cycle of IVF/ICSI for the first time or for a repeat stimulated cycle after an unsuccessful cycle in the eight weeks prior to survey completion. Individuals were also required to be aged 18 or older (upper age limit of 42 years for women) and able to respond in English. In total 881 clicked on the survey link, 118 did not consent, 41 were excluded after data screening, 57 did not meet the inclusion criteria, 331 started the survey but did not complete it, 28 had missing data on critical variables (e.g., age) and 306 completed the survey (40.1% completion, 57 men, 249 women). Participants were allocated to either the willing or unwilling to plan for multiple cycles of treatment group based on their responses to three variables: willingness to plan for three complete cycles, whether they would choose to have another cycle of IVF and whether they would continue treatment after an unsuccessful cycle. Quantitative questions gathered data on preferences towards planning for multiple cycles (i.e., attitudes, subjective norms and perceived behavioural control), challenges, benefits of planning for multiple cycles, decisional conflict experienced and treatment decisions involved in planning for multiple cycles. Demographic, fertility and fertility treatment information were also collected. Qualitative questions gathered textual data on other perceived benefits and challenges of planning for multiple cycles and solutions to the challenges. Descriptive and inferential statistics were used on quantitative data. Thematic analysis (inductive coding) was performed on the textual data. Overall, 73.2% (n = 224) of participants had had a consultation to start a first cycle of IVF/ICSI. Participants were on average 33 years of age and had been trying to conceive for three years. A total of 63.07% (n = 193) were university educated. A total of 56% (n = 172) of participants were willing to plan for multiple cycles of IVF/ICSI in advance of treatment. Repeated measures ANOVA, t-tests and chi-square analysis showed the willing group to be significantly more likely to have been in a relationship for longer (p<.05), have higher education (p<.05) and be resident in the United Kingdom (p<.05). The willing group had positive attitudes towards planning for multiple cycles (p<.001) and stronger agreement with subjective norms (p<.001), perceived behavioural control (p<.001), benefits of planning for multiple cycles (p<.01) and felt able and attached more importance to making treatment decisions in advance of treatment (p<.05). Data saturation was achieved for the thematic analysis of textual data which revealed a total of four other challenges (e.g., less decisional freedom) and six other benefits (e.g., having a realistic view of treatment) to planning for multiple cycles. Qualitative analysis also revealed that most patients could anticipate and provide solutions for the nine challenges of planning for multiple cycles (e.g., using flexible working for the negative effect of treatment on work). Limitations included the outcome measure being willingness to plan for multiple cycles rather than actual multi-cycle planning behaviour. The unwilling group represented a heterogeneous group with possibly unknown motivational coherence (e.g., definitely against planning, ambivalent about planning). Other limitations included the cross-sectional nature of the survey and the recruitment source. Treatment consultations about undergoing fertility treatment could re-frame treatment to be a multi-cycle process in line with patient's willingness, preference and decision-making. This multi-cycle approach could empower patients and clinicians to discuss treatment expectations realistically and formulate fully informed treatment plans that take account of the high likelihood of cycle failure in addition to the treatment decisions that may need to be made during treatment when a cycle fails. This multi-cycle approach could help us support patients in adhering to their treatment plans even when faced with challenges, and help ascertain the level of treatment engagement possible to achieve parenthood goals. This project is funded by an Investigator-Sponsor Non-interventional Study from Merck Serono Ltd (MS200059_0010). Professor Boivin reports personal fees from Merck KGaA, Darmstadt, Germany, Merck AB an affiliate of Merck KGaA, Darmstadt Germany, Theramex, Ferring Pharmaceuticals A/S, grant from Merck Serono Ltd, outside the submitted work and that she is co-developer of Fertility Quality of Life (FertiQoL) and MediEmo app. Dr. Gameiro reports consultancy fees from Ferring Pharmaceuticals A/S, Access Fertility and SONA-Pharm LLC, and grants from Merck Serono Ltd. Dr. Harrison declares no conflicts of interest. n/a.

Harrison C ，Gameiro S ，Boivin J 《-》