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 《-》

Talking about possible IVF/ICSI failure and need for multiple cycles in treatment planning: qualitative investigation of multi-cycle planning and its acceptability to patients and staff.

What are patients' and fertility staff views of talking about possible IVF/ICSI failure and need for multiple cycles in treatment planning? Healthcare professionals (HCPs) typically plan treatment on a cycle-by-cycle basis but HCPs and patients see benefits in talking about possible IVF/ICSI failure and the consequent need for multiple cycles to better prepare patients for this possibility, to support them through treatment challenges and to foster a sense of collaboration with the clinic in achieving the shared goal of treatment success. Many patients need more than one round of IVF/ICSI stimulation to achieve their parenthood goals. About 60% of patients are willing to plan for multiple cycles of treatment in advance of treatment engagement. However, it is not clear how patients are informed about the high possibility of failure and the subsequent need for multiple cycles during their treatment planning consultations, and how approaches could be optimized. Qualitative focus groups with HCPs working at fertility clinics, patient advocates employed by patient charities (April 2020) and patients (July and August 2020). Patients were eligible if they had had a consultation to start a first/repeat stimulated IVF/ICSI cycle in the 8 weeks prior to participation, were aged 18 or older (upper age limit of 42 years for women), in heterosexual relationships and fluent in English. Eligible HCPs and patient advocates were those employed at a fertility clinic or charity, respectively. Focus group topic guides progressed from general questions about fertility consultations to if and how the possibility of treatment failure and need for multiple cycles was introduced and discussed in (attended/own) clinics. After, preferences regarding planning IVF/ICSI on a multi-cycle or cycle-by-cycle basis were explored. Focus groups were recorded, and recordings transcribed and analysed using framework analysis to identify shared, unique and incongruent themes across participant groups. Twelve HCPs, 2 patient advocates and 10 patients participated in six semi-structured online focus group discussions. All patients were childless and had been trying to conceive for ∼3 years. Framework analysis generated four themes and one meta-theme across participant groups. The meta-theme showed planning IVF on a cycle-by-cycle basis is the norm at clinics and that this affects how treatment is planned and the acceptability of a shift towards planning for multiple cycles, which was perceived as beneficial despite some apprehension. The four themes were: (i) heterogeneity in information provision during treatment planning; (ii) the need for improved HCP-patient collaboration; (iii) the need to temper optimism about treatment success; and (iv) apprehension, benefits and preferences regarding multi-cycle planning. Most patients were women from private fertility clinics with no previous treatment experience recruited from social media websites, mainly associated with patient support groups. Similarly, most HCPs were women from private fertility clinics. The findings suggest that shifting from cycle-by-cycle to multi-cycle approaches in IVF planning is possible. Achieving this shift, like other shifts in IVF (e.g. single embryo transfer), is likely to require collaboration among all stakeholders (e.g. users, staff, policymakers, regulators) to ensure that costs and benefits are balanced through using appropriate benchmarks, avoiding deflating optimism, fostering a sense of collaboration and supporting patients through challenges of multi-cycle IVF. This research is funded by an Investigator-Sponsor Noninterventional Study from Merck Serono Ltd (MS200059_0010), 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'. Prof. J.B. 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 S.G. reports consultancy fees from Ferring Pharmaceuticals A/S, Access Fertility and SONA-Pharm LLC, and grants from Merck Serono Ltd, an affiliate of Merck KGaA, Darmstadt, Germany. Dr C.H. declares no conflicts of interest. N/A.

Harrison C ，Boivin J ，Gameiro S 《-》

Discussing the possibility of fertility treatment being unsuccessful as part of routine care offered at clinics: patients' experiences, willingness, and preferences.

Are patients willing to discuss the possibility of treatment being unsuccessful as part of routine care offered at clinics, and what are the factors associated with this willingness? Nine in every 10 patients are willing to discuss this possibility as part of routine care, with willingness being associated with higher perceived benefits, lower barriers, and stronger positive attitudes towards it. Fifty-eight percent of patients who complete up to three cycles of IVF/ICSI in the UK do not achieve a live birth. Offering psychosocial care for unsuccessful fertility treatment (PCUFT), defined as assistance and guidance on the implications of treatment being unsuccessful, could reduce the psychosocial distress patients experience when it happens, and promote positive adjustment to this loss. Research shows 56% of patients are willing to plan for an unsuccessful cycle, but little is known about their willingness and preferences towards discussing the possibility of definitive unsuccessful treatment. The study was of cross-sectional design, comprising a theoretically driven and patient-centred bilingual (English, Portuguese) mixed-methods online survey. The survey was disseminated via social media (April 2021-January 2022). Eligibility criteria included being aged 18 or older, waiting to or undergoing an IVF/ICSI cycle, or having completed a cycle within the previous 6 months without achieving a pregnancy. Out of 651 people accessing the survey, 451 (69.3%) consented to participate. From these, 100 did not complete 50% of the survey questions, nine did not report on the primary outcome variable (willingness), and 342 completed the survey (completion rate 75.8%, 338 women). The survey was informed by the Health Belief Model (HBM) and Theory of Planned Behaviour (TPB). Quantitative questions covered sociodemographic characteristics and treatment history. Quantitative and qualitative questions gathered data on past experiences, willingness, and preferences (with whom, what, how and when) to receive PCUFT, as well as theory-informed factors hypothesized to be associated with patients' willingness to receive it. Descriptive and inferential statistics were used on quantitative data about PCUFT experiences, willingness, and preferences, and thematic analysis was applied to textual data. Two logistic regressions were used to investigate the factors associated with patients' willingness. Participants were, on average, 36 years old and most resided in Portugal (59.9%) and the UK (38.0%). The majority (97.1%) were in a relationship for around 10 years, and 86.3% were childless. Participants were undergoing treatment for, on average, 2 years [SD = 2.11, range: 0-12 years], with most (71.8%) having completed at least one IVF/ICSI cycle in the past, almost all (93.5%) without success. Around one-third (34.9%) reported having received PCUFT. Thematic analysis showed participants received it mainly from their consultant. The main topic discussed was patients' low prognosis, with the emphasis being put on achieving a positive outcome. Almost all participants (93.3%) would like to receive PCUFT. Reported preferences indicated that 78.6% wanted to receive it from a psychologist/psychiatrist/counsellor, mostly in case of a bad prognosis (79.4%), emotional distress (73.5%), or difficulties in accepting the possibility of treatment being unsuccessful (71.2%). The preferred time to receive PCUFT was before initiating the first cycle (73.3%), while the preferred format was in an individual (mean = 6.37, SD = 1.17; in 1-7 scale) or couple (mean = 6.34, SD = 1.24; in 1-7 scale) session. Thematic analysis showed participants would like PCUFT to provide an overview of treatment and all possible outcomes tailored to each patient's circumstances and to encompass psychosocial support, mainly focused on coping strategies to process loss and sustain hope towards the future. Willingness to receive PCUFT was associated with higher perceived benefit of building psychosocial resources and coping strategies (odds ratios (ORs) 3.40, 95% CI 1.23-9.38), lower perceived barrier of triggering negative emotions (OR 0.49, 95% CI 0.24-0.98), and stronger positive attitudes about PCUFT being beneficial and useful (OR 3.32, 95% CI 2.12-5.20). Self-selected sample, mainly composed of female patients who had not yet achieved their parenthood goals. The small number of participants unwilling to receive PCUFT reduced statistical power. The primary outcome variable was intentions, and research shows a moderate association between intentions and actual behaviour. Fertility clinics should provide patients with early opportunities to discuss the possibility of their treatment being unsuccessful as part of routine care. PCUFT should focus on minimizing suffering associated with grief and loss by reassuring patients they can cope with any treatment outcome, promoting coping resources, and signposting to additional support. M.S.-L. holds a doctoral fellowship from the Portuguese Foundation for Science and Technology, I.P. [Fundação para a Ciência e a Tecnologia] (FCT; SFRH/BD/144429/2019). R.C. holds a post-doctoral fellowship supported by the European Social Fund (ESF) and FCT (SFRH/BPD/117597/2016). The EPIUnit, ITR and CIPsi (PSI/01662) are also financed by FCT through the Portuguese State Budget, in the scope of the projects UIDB/04750/2020, LA/P/0064/2020 and UIDB/PSI/01662/2020, respectively. Dr Gameiro 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, grants from Merck Serono Ltd, an affiliate of Merck KgaA, Darmstadt, Germany. N/A.

Sousa-Leite M ，Costa R ，Figueiredo B ，Gameiro S ... -  《-》

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 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 ... -  《-》