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STUDY QUESTIONIs it possible to design an ART Treatment Planning and Continuation Intervention (TPCI) that is considered acceptable and feasible to patients and healthcare professionals (HCPs)?SUMMARY ANSWERHCPs 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.WHAT IS KNOWN ALREADYPeople 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.STUDY DESIGN, SIZE, DURATIONQualitative 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.PARTICIPANTS/MATERIALS, SETTING, METHODSHCPs 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.MAIN RESULTS AND THE ROLE OF CHANCEThirteen 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.LIMITATIONS, REASONS FOR CAUTIONAll 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.WIDER IMPLICATIONS OF THE FINDINGSThe 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.STUDY FUNDING/COMPETING INTEREST(S)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.TRIAL REGISTRATION NUMBERN/A.

STUDY QUESTION What are fertility staff experiences of managing COVID-19-related uncertainty after fertility clinics re-opened? SUMMARY ANSWER Staff identified many COVID-19-related uncertainty sources, the main being the COVID-19 health threat, to which most clinics and staff responded effectively by implementing safety protocols and building strong collaborative environments that facilitated the acquisition and application of information to guide organizational responses during a rapidly changing situation, but with costs for staff and patients. WHAT IS KNOWN ALREADY COVID-19 created significant disruption in fertility care delivery, including temporary clinic closure and treatment delay. Patients experienced significant distress, including concerns regarding the impact of COVID-19 and its vaccine on fertility and pregnancy. Multiple studies show that COVID-19-related uncertainty is a major threat and burden for healthcare staff, but this has not been investigated in reproductive medicine. STUDY DESIGN, SIZE, DURATION A cross-sectional, online mixed-method bilingual (English, Spanish) survey (active 25 January–23 May 2021) was distributed to fertility staff across the UK, Latin America, and Africa. PARTICIPANTS/MATERIALS, SETTING, METHODS Eligibility criteria were being a healthcare worker at a fertility clinic that had re-opened since its COVID-19-related closure, 18 years of age or older and ability to respond in English or Spanish. The survey was created in English, translated to Spanish, made available using Qualtrics, and consisted of four parts: (i) background and physical and mental wellbeing, (ii) open-ended questions regarding COVID-19 uncertainty, (iii) appraisal items regarding perceptions and impact of uncertainty, and (iv) changes in the workplace. The British Fertility Society and the African Network and Registry of Assisted Reproduction circulated the survey across the UK and Africa via email hyperlinks and social media platforms. The Argentinian Society of Reproductive Medicine and the Latin American Network of Assisted Reproduction distributed the survey across Latin America in the same manner. Thematic analysis was performed on responses from open-ended question to produce basic codes. Deductive coding grouped sub-themes across questions into themes related to the theory of uncertainty management. Descriptive statistics and repeated measures analysis of variance were used on the quantitative data. MAIN RESULTS AND THE ROLE OF CHANCE In total, 382 staff consented to the survey, 107 did not complete (28% attrition), and 275 completed. Sixty-three percent were women, 69% were physicians, and 79% worked at private clinics. Thematic analysis produced 727 codes, organized in 92 sub-themes, and abstracted into 18 themes and one meta-theme reflecting that uncertainty is stressful but manageable. The types of uncertainties related to the threat of COVID-19 (20.6%), unpredictability of the future (19.5%), failure of communication (11.4%), and change in the workplace (8.4%). Staff appraisals of negative and positive impact of uncertainty were significantly lower (P LIMITATIONS, REASONS FOR CAUTION Participants were self-selected, and most were physicians and embryologists working at private clinics based in Latin America. The study did not account for how variability in national and regional COVID-19 policy shaped staff experiences of uncertainty. WIDER IMPLICATIONS OF THE FINDINGS To address COVID-19 uncertainty, clinics need to promote collaborative (clinic, staff, patients) processing of uncertainty, clear team coordination and communication, organizational flexibility, and provision of support to staff and patients, with an emphasis on cognitive coping to decrease threat of and increase tolerance to uncertainty. Uncertainty management interventions bespoke to fertility care that integrate these components may increase clinics resilience to COVID-19-related and other types of uncertainty. STUDY FUNDING/COMPETING INTERESTS Cardiff University funded this research. S.G. reports consultancy fees from Ferring Pharmaceuticals A/S, speaker fees from Access Fertility, SONA-Pharm LLC, Meridiano Congress International, and Gedeon Richter, and grants from Merck Serono Ltd. F.Z.-H. reports speaker fees from Ferring Pharmaceuticals A/S and that he is a chair of the Latin American Registry of ART, Committee of Ethic and Public Policies, and Chilean Society of Obstetrics and Gynecology and a vice chair of the International Committee for monitoring ART. K.A., N.C., G.B., and J.B. report no conflict in relation to this work. TRIAL REGISTRATION NUMBER N/A.

Fertility experts have advocated addressing preventable causes of infertility and early intervention. However, awareness of risk factors is low, especially in low- and middle-income countries where the prevalence of infertility is high. To address this lack of awareness, the Fertility Awareness Tool (FertiSTAT) was adapted for use in Sudan and other low-resource countries. The aims of this study were to ascertain the need for fertility education in Sudan (Aim 1), and to gauge the acceptability and feasibility of implementing the FertiSTAT in Sudan (Aim 2), both from the patients’ perspective. Convenience sampling was used to recruit participants for semi-structured-in-depth interviews from a fertility clinic in Sudan. We collected sociodemographic information, medical and reproductive history, asked about fertility knowledge, administered the FertiSTAT and asked about the acceptability of the FertiSTAT. Thematic analysis was conducted for qualitative data. Twenty participants were included; of these, 17 were female, 13 were educated beyond secondary school, the mean age was 32.8 years, and the mean duration of infertility was 4.1 years. Ten themes emerged: of these, three themes addressed Aim 1: ‘desire for fertility information’, ‘state of fertility knowledge’ and ‘benefits of fertility education’; and seven themes addressed Aim 2: ‘specific suggestions for the tool’, ‘factors influencing the acceptability and feasibility of implementing the tool’, ‘challenges and barriers to implementation’, ‘self-disclosure’, ‘understanding of being at risk’, ‘compatibility with worldview’ and ‘cultural tailoring’. Fertility education was viewed as necessary and beneficial; however, participants thought that lack of acceptability of sensitive topics would hinder the implementation of the FertiSTAT. Acceptability and feasibility would be enhanced if challenges were addressed in a culturally sensitive manner using cultural tailoring of materials to increase compatibility with individual worldviews.

This study explored women's lived experience of making fertility decisions six years after attending the Fertility Assessment and Counselling (FAC) clinic in Copenhagen, Denmark, which is a personalised fertility awareness intervention. We conducted a qualitative interview study with 24 women who attended the FAC clinic 6 years earlier. Interviews were semi-structured and broadly examined the women's perceptions and experience of the intervention during follow-up. Data was analysed using a phenomenological framework and themes were identified related to women's experience of making fertility decisions after attending the FAC clinic. The overarching theme regarding the women's lived experience of making fertility decisions after attending the FAC clinic was: Fertility decisions were guided by the 'family clock'. There were four themes: (i) Deciding to 'get started' by attending the FAC clinic; (ii) Sense of making informed and empowered decisions; (iii) Influence of partner status on fertility decisions; and (iv) Decisions dictated by circumstance over preference and knowledge. At follow-up, the majority (21 women, 88%) had become parents. More than half of the women said that they had not achieved their desired family size. Consideration of women's 'family clock' is necessary in personalised fertility awareness interventions to enable women to achieve their family goals.

Research question\ud What are the effects of using a fertility education chatbot, i.e. automatic conversation programme, on knowledge, intentions to improve preconception behaviour and anxiety?\ud \ud Design\ud A three-armed, randomized controlled trial was conducted using an online social research panel. Participants included 927 women aged 20–34 years who were randomly allocated to one of three groups: a fertility education chatbot (intervention group), a document about fertility and preconception health (control group 1) or a document about an irrelevant topic (control group 2). Participants’ scores on the Cardiff Fertility Knowledge Scale and the State-Trait Anxiety Inventory, their intentions to optimize preconception behaviours, e.g. taking folic acid, and the free-text feedback provided by chatbot users were assessed.\ud \ud Results\ud A repeated-measures analysis of variance showed significant fertility knowledge gains after the intervention in the intervention group (+9.1 points) and control group 1 (+14.9 points) but no significant change in control group 2 (+1.1 points). Post-test increases in the intentions to optimize behaviours were significantly higher in the intervention group than in control group 2, and were similar to those in control group 1. Post-test state anxiety scores were significantly lower in the intervention group than in control group 1 and control group 2. User feedbacks about the chatbot suggested technical limitations, e.g. low comprehension of users’ words, and pros and cons of using the chatbot, e.g. convenient versus coldness.\ud \ud Conclusions\ud Providing fertility education using a chatbot improved fertility knowledge and intentions to optimize preconception behaviour without increasing anxiety, but the improvement in knowledge was small. Further technical development and exploration of personal affinity for technology is required.

What are the emotional effects of infertility on patients, partners, or both, and how can qualitative thematic analyses and natural language processing (NLP) help evaluate textual data?A cross-sectional, multi-country survey conducted between March 2019 and May 2019. A total of 1944 patients, partners, or both, from nine countries responded to the open-ended question asking about their initial feelings related to an infertility diagnosis. A mixed-method approach that integrated NLP topic modelling and thematic analyses was used to analyse responses. Sentiment polarity was quantified for each response. Linear regression evaluated the association between patient characteristics and sentiment negativity.Common emotional reactions to infertility diagnoses were sadness, depression, stress, disappointment, anxiety, frustration, confusion and loss of self-confidence. NLP topic modelling found additional reactions, i.e. shared feelings with partners, recollections about causes of infertility and treatment experience. Responses to the open-ended question were brief (median: three words) with 71.8% conveying negative sentiments. Some respondent characteristics showed small but significant associations with sentiment negativity, i.e. country (Spain, China and France were more negative than the USA, P0.001, P0.003 and P0.009 respectively), treatment engagement (no treatment was more negative than one or more treatment, P = 0.027) and marital status (missing/other was more negative than divorced, P = 0.003).Infertility diagnoses create an emotional burden for patients and partners. The mixed-method approach provides a compelling synergy in support of the validity of these findings and shows potential for these techniques in future research.

STUDY QUESTION What are patients’ and fertility staff views of talking about possible IVF/ICSI failure and need for multiple cycles in treatment planning? SUMMARY ANSWER 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. WHAT IS KNOWN ALREADY 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. STUDY DESIGN, SIZE, DURATION 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. PARTICIPANTS/MATERIALS, SETTINGS, METHOD 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. MAIN RESULTS AND THE ROLE OF CHANCE 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. LIMITATIONS, REASONS FOR CAUTION 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. WIDER IMPLICATIONS OF THE FINDINGS 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. STUDY FUNDING/COMPETING INTEREST(S) 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. TRIAL REGISTRATION NUMBER N/A.

IntroductionBirth rates have been declining in many advanced societies including Singapore. We designed two interventions with vastly different resource requirements, which include fertility education, personalised fertility information and a behavioural change component targeting modifiable psychological constructs to modify fertility awareness and childbearing intentions. We aim to evaluate the effect of these two interventions on knowledge, attitudes and practice around childbearing compared with a control group among young married couples in Singapore and understand the implementation factors in the setting of an effectiveness-implementation hybrid type 1 three-arm randomised trial.Methods and analysisWe will randomise 1200 young married couples to no intervention (control), Fertility Health Screening group (FHS) or Fertility Awareness Tools (FAT) in a 7:5:5 ratio. Couples in FHS will undergo an anti-Mullerian hormone test and semen analysis, a doctor’s consultation to explain the results and standardised reproductive counselling by a trained nurse. Couples in FAT will watch a standardised video, complete an adapted fertility status awareness (FertiSTAT) tool and receive an educational brochure. The attitudes, fertility knowledge and efforts to achieve pregnancy of all couples will be assessed at baseline and 6 months post-randomisation. Birth statistics will be tracked using administrative records at 2 and 3 years. The primary outcome is the change in the woman’s self-reported intended age at first birth between baseline and 6 months post-randomisation. In addition, implementation outcomes and cost-effectiveness of the two interventions will be assessed.Ethics and disseminationThis study has been reviewed and approved by the Centralized Institutional Review Board of SingHealth (2019/2095). Study results will be reported to the study funder and there are plans to disseminate them in scientific conferences and publications, where authorship will be determined by the International Committee of Medical Journal Editors guidelines.Trial registration numberNCT04647136; ClinicalTrails.gov Identifier.

What is the psychological impact of infertility on infertile patients and partners of infertile patients?This online, international, quantitative survey assessed the impact of infertility on mental health, relationships and daily activities for 1944 respondents. Respondents were male or female infertile patients (n = 1037) or partners to infertile patients (n = 907; not necessarily partners of the patient sample) and were recruited at different stages of the treatment journey.The most common emotions were 'sadness' at infertility diagnosis and 'anxiety' during treatment. Emotions differed in nature and intensity throughout the journey. Envy of others who achieved pregnancy was frequently reported by women. More than half of respondents (60.4%; n = 1174) perceived the infertility journey to have impacted their mental health, and 44.1% (n = 857) of respondents sought mental health support. More patients reported mental health impacts (70.1%, n = 727) than partners (49.3%, n = 447). One in three respondents indicated that their relationship had suffered due to the infertility diagnosis. Of these respondents, 55.0% (n = 409) strongly agreed that infertility caused an emotional strain. Patients more often than partners reported a detrimental impact on daily activities. Respondents most commonly agreed with statements regarding an 'effect on work-life balance'.Treatment journey stages are defined by their impact profile, which differs between infertile patients and partners of infertile patients. Negative impacts are diverse (mental health, relational, daily activities). There was disparity between the number of respondents reporting mental health issues and the number seeking mental health support. This indicates the need for support services tailored to different treatment stages.

The current study examined whether the Theory of Planned Behaviour (TPB) could account for the disproportionately low participation rates of men in childbearing and fertility research and whether the addition of distal factors could help identify the men missing from this specific field of health research. The study was of longitudinal design, comprising two online surveys measuring the TPB constructs (attitudes, subjective norms, perceived behavioural control), distal factors (e.g., desire for a child) intentions to participate in childbearing research (time 1) and childbearing research behaviour (time 2). More women (n=623) than men (n=176) participated. Structural models revealed the TPB constructs accounted for 37% and 1% of the variance in intentions and behaviour respectively. Attitudes had the strongest association with intentions (β=.53). Men had significantly less favourable attitudes (p=.000) and lower intentions than women (p=.01). TPB constructs fully and partially mediated associations between distal factors and intentions. The modification of attitudes is likely to be the mechanism that would elicit intention (and behaviour) change amongst those likely to be missing from childbearing and fertility research, namely men not yet at the stage of starting a family. Increasing male participation will help identify unmet needs in research and policy that concern men.

Study question Is the emotional experience of patients during IVF different since the start of the global Covid-19 pandemic? Summary answer Tracking data since re-opening demonstrated patients lower positive challenge emotions but no significant change in harm, threat, or stress. What is known already Covid-19 caused widespread shutdown of fertility centres, including in the UK, when the HFEA mandated closure from March until May 2020. Research shows clinic closure and an uncertain future were a significant psychological burden for patients anticipating treatment. However, emotional experiences before, during and after closure have not yet been compared, which is the aim of the study. Study design, size, duration Retrospective single-centre analysis of anonymised emotional tracking data entered by 707 patients using the MediEmo smartphone app alongside their IVF cycle, from May 2017-September 2020. MediEmo includes medication timeline/ notifications, coping tools and emotional tracking. Patients rate 2 questions daily in each emotion domain (challenge, threat, harm, e.g. ‘I am feeling tense’) on a 0-3 scale and indicate coping ability (‘I am unable to cope with the stress I am experiencing’) on a binary scale. Participants/materials, setting, methods Egg donor, recipient and fertility preservation cycles were excluded. First, mood scores were analysed by 2020 month of entry to capture the emotional impact of closure. Second, “Pre-Covid” (May 2017-Feb 2020) and “After Re-opening” (May 2020–Sept 2020) emotional experiences were compared, using student t-tests. Mean and standard deviation of scores in each mood domain entered on each cycle day were calculated, centred on luteal day 0/ egg collection, from cycle day -14 to + 14. Main results and the role of chance Graphical presentation of emotional data by month clearly demonstrates the significant increase in threat, harm and stress emotions and reduced positive emotions experienced immediately prior to and during mandatory clinic closure. Of patients entering emotional data during closure in March/April 2020, 40% (14/35) stated they felt unable to cope with the stress they were currently experiencing. From May 2020 after the clinic reopened, analysis of in-cycle emotional tracking data showed there are no significant differences in harm or threat emotion levels or numbers reporting intolerable stress during IVF, compared to cycles pre-pandemic (May17-Feb 2020). Patients undertaking IVF cycles since closure are logging lower challenge scores (confident, encouraged, positive, hopeful), demonstrating less optimism, particularly in the ‘two-week wait’ phase of the cycle. The mean (s.d) of challenge scores pre-Covid was 1.50 (1.07), compared to 1.38 (1.04) after re-opening, p = 0.00085. The women who had treatment cycles post re-opening from May 2020 onwards were older (33.4(5.2) vs 32.6(4.4)), which may reflect clinical treatment prioritisation decisions. There was no significant differences in number of eggs collected (mean(s.d) Pre-Covid 12.08 (8.0) vs After re-opening 11.83 (9.4), p = 0.84) or live birth/ ongoing pregnancy rates for undelivered pregnancies (p = 0.69) between the groups. Limitations, reasons for caution Emotional data was only available for those who chose to use MediEmo, entered emotional tracking data and who gave consent for use of their clinical data in research. As such, this analysis may not fully reflect all patients’ experiences. Most of the available data were entered prior to the pandemic. Wider implications of the findings For Covid-19 safety reasons, patients currently have less in-person staff contact when undertaking IVF. The findings reassuringly suggest emotional wellbeing was not markedly different in most domains. However, daily ratings did show the emotional fall-out of clinic closures which for most threatened attainability of parenthood goals (e.g., less hope). Trial registration number Not applicable

Study question How is possibility of failure and potential need for multiple cycles discussed with patients during the first or repeat IVF/ICSI treatment consultation? Summary answer Health Care Professionals plan treatment on a cycle-by-cycle basis because it is the normative way to plan treatment, but patients see advantages in multi-cycle planning What is known already Many patients need more than one round of IVF/ICSI stimulation to achieve their parenthood goals. A recent study has found around 60% of patients to be willing to plan for multiple cycles of treatment. However, it is not clear how patients are informed fully about the high possibility of treatment failure and the subsequent need for multiple cycles during their treatment planning consultations Study design, size, duration Qualitative focus groups with health care professionals (HCP) patient advocates (April 2020) and patients (July and August 2020, respectively). Patients were eligible if they had had a consultation to start a first/repeat stimulated IVF/ICSI cycle in the eight weeks prior to participation, were aged 18 or older (upper age limit of 42 years for women) and fluent in English. Eligible Health HCPs and patient advocates were those employed at a fertility clinic or charity, respectively Participants/materials, setting, methods HCP, patient advocate and patient focus group topic guides started with general questions about fertility consultations and progressed to discuss if and how the possibility of treatment failure and need for multiple cycles was introduced and discussed, and then preferences regarding planning IVF/ICSI on a multi-cycle rather than a single cycle basis. Focus groups were recorded, transcribed and analysed using framework analysis which allowed examination of shared, unique and incongruent thematic content across participant groups Main results and the role of chance Twelve HCPs, 2 patient advocates and 11 patients participated in seven semi-structured online focus group discussions. Framework analysis revealed 52 codes (e.g., possibility of failure tentatively introduced; discussion of multiple cycles dependent on clinical/patient benchmarks) abstracted into 17 higher-level categories (e.g., Failure is a sensitive topic to approach; IVF treatment failure is the norm). Synthesis of categories revealed four themes and one meta theme The meta theme showed planning treatment on a cycle-by-cycle basis was the norm. This meta-theme was supported by four themes: (1) ‘culture of communication’ that dictated benchmarks (e.g., clinic, national live birth rate) and definition of key concepts (‘complete’ cycle) that underpinned divergence between clinics; (2) ‘HCP-patient dynamics’ indexing degree of shared decision-making, advance preparation and involvement of partners in planning; (3) ‘tempering optimism’ that described tailoring, balancing and emotion management in giving personal chances of success; and (4) ‘transitioning to multi-cycle planning’ which identified worries of multi-cycle planning (e.g., need to learn from failure). Limitations, reasons for caution The majority of patients were women from private fertility clinics with no previous treatment experience recruited from social media websites, mainly associated with patient support groups. Similarly, the majority of HCPs were women from private fertility clinics. Informative comparisons across treatment stage, gender and funding source were therefore not possible Wider implications of the findings HCPs are hesitant towards multi-cycle planning. However, patients show openness, suggesting a cultural shift from the single cycle norm of planning IVF/ICSI may be possible. If adopted by clinics, HCPs patients and fertility organisations, multi-cycle planning could encourage patients to create informed treatment expectations and plans prior to treatment engagement Trial registration number MS200059_001

Study question What is the impact of providing couples with their IVF-prognosis on expectations and anxiety in women and men on the day of embryo transfer? Summary answer Only couples with a less than average IVF-prognosis updated their high expectations and IVF-prognosis was negatively associated with anxiety, especially in women. What is known already Female IVF-patients are known to expect a pregnancy rate per IVF-cycle of no less than 49-55%. Qualitative interviews and a survey showed that well informed women expect unrealistically high pregnancy rates as they think that their (family’s) fertility and their clinic is better than average. Several prognostic models have recently been published. The adapted van Loendersloot model including clinical and laboratory characteristics proved performant for our clinic (AUC=0.74) and was validated internally (Devroe et al, BMJ Open, 2020). The impact of providing couples with their IVF-prognosis on expectations and wellbeing of female and male patients has yet to be studied. Study design, size, duration A prospective survey, questioning a final sample of 148 partnered individuals, completing their 2nd-6th IVF-cycle (2019-2020) in a University clinic, on the days of oocyte aspiration (OA) and fresh embryo transfer (ET). Thirty other partnered individuals declined participation (participation rate=85%) and 26 were excluded due to ET-cancellation. The IVF-prognosis (live birth rate, LBR, per completed IVF-cycle including fresh and frozen ETs from the same ovarian stimulation) was calculated with the adapted van Loendersloot model. Participants/materials, setting, methods Each partner reported their perception of their expected IVF-LBR on a visual analogue scale on the day OA. After being informed on their IVF-prognosis by gynaecologists, they re-rated their expected IVF-LBR and filled out the reliable ‘STAI-State-Anxiety Inventory’ on the day of fresh ET. Linear mixed models, taking account of partnering and assessing the association with gender, explored whether individuals updated their expected IVF-LBR after receiving their IVF-prognosis and whether IVF-prognosis and anxiety were associated. Main results and the role of chance The mean IVF-prognosis was 30.9% (±16.8). The 148 partnered individuals had a mean expected IVF-LBR of 59.1% (±20.0) on the day of OA (no gender effect; p = 0.079). After being informed on their IVF-prognosis (day of ET), women’s and men’s mean expected IVF-LBR was 50.9% (±24.5) and 58.1% (±22.1), respectively (gender effect; p = 0.002). Linear mixed models, including couple and time as random factors, did not show an effect of time on expected IVF-LBRs (p = 0.15). Although women were more likely than men to update their expected IVF-LBR (p = 0.002), the updates were not significantly different from the IVF-LBR expected on the day of OA (p = 0.10). Women were more anxious than men (41.5±10.6 and 21.9±7.2, respectively, p Limitations, reasons for caution This is an explorative study in preparation of an adequately powered randomized controlled trial, testing whether couples who are informed on their IVF-prognosis update their expected IVF-LBR and whether this causes anxiety, as compared to care as usual in which couples are not informed on their IVF-prognosis. Wider implications of the findings Men and especially women with a less than average prognosis update their IVF-expectations after having received this prognosis which may trigger anxious reactions. These findings should be re-examined in an RCT. Following up the effect of sharing IVF-prognoses on longer-term distress and IVF-discontinuation would be interesting. Trial registration number not applicable

Study question Is the emotional experience different in FET and stimulated IUI cycles compared to IVF cycles? Summary answer Emotional tracking data demonstrated cautious optimism and lower harm emotions in IUI, but FET cycles are associated with higher harm emotions than fresh IVF. What is known already It is sometimes claimed on clinic websites and by advocates for elective freeze all that FET cycles are inherently less stressful. However, little research evaluates the emotional difference between fresh and frozen cycles and the assumed emotional ease of FET may reflect clinician interpretation/bias rather than patient’s lived experiences. Many undertaking FET will have experienced disappointment in a fresh cycle and with increasing cycles comes increased cost. IUI treatment is perceived as less physically and emotionally intense, but studies have shown increased depression levels after a failed IUI cycle and high drop-out. Study design, size, duration Retrospective single-centre analysis of anonymised emotional tracking data entered by 707 patients using MediEmo app alongside IVF, 104 during stimulated IUI and 65 during medicated FET from May 2017-September 2020. MediEmo includes medication timeline/ notifications, coping tools and emotional tracking. Patients rate 2 questions daily in each emotion domain (challenge, threat, harm, e.g. ‘I am feeling tense’) on a 0-3 scale and indicate coping ability (‘I am unable to cope with the stress I’m experiencing’). Participants/materials, setting, methods Egg donor, recipient and fertility preservation cycles were excluded. Mean and standard deviation of scores in each mood domain entered per cycle day were calculated, centred on luteal day 0/ egg collection, from cycle day +/-14. Between group analysis performed using one-way analysis of variance (ANOVA) is presented here. Time series analysis, graphical presentation of emotions by cycle day and analysis of cycles resulting in live birth or return for further treatment will be presented. Main results and the role of chance Analysis of emotional tracking data demonstrated patients experience higher levels of positive challenge emotions (confident/encouraged/hopeful/positive) during FET and IUI cycles than fresh IVF: mean(s.d) score FET 1.64(1.1), IUI 1.74(0.89), IVF 1.48(1.06) (ANOVA p Threat emotions (worried/nervous/anxious/tense) are significantly lower in FET compared to IVF and IUI cycles: FET mean 0.67(0.91), IUI 0.97(0.90), IVF 0.87(0.91), (ANOVA p However, the harm emotions (sad/discouraged/disappointed) experienced by patients are significantly higher in FET, mean 0.62(0.89) compared to IVF 0.50(0.81), which are higher than IUI cycles, 0.36(0.68), (ANOVA p As this is retrospective observational data, there are differences between groups in addition to treatment modality, e.g. mean patient ages in the FET and IUI groups were older than those entering data during IVF; FET 34.2(4.09), IUI 33.9(5.2), IVF 32.6(4.47). However, age was not correlated with levels of challenge emotions, suggesting assumptions that patient emotions, e.g. hopefulness, are closely linked to objective prognosis may be flawed. Limitations, reasons for caution Emotional data was only available for those who chose to use MediEmo, entered emotional tracking data and who gave consent for use of data in research. As such, this analysis may not fully reflect all patients’ experiences. However, these limitations apply to all groups and should not prevent useful comparison. Wider implications of the findings Patients have less contact with clinic staff during FET or IUI than fresh IVF cycles. Fertility staff need to ensure availability of support during all treatment cycles and be empathic, particularly for those embarking on FET, who may still be coming to terms with a failed fresh transfer cycle. Trial registration number Not applicable

The 36-item Fertility Quality of Life (FertiQoL) tool is increasingly used in research and practice. It measures quality of life in four personal domains (emotional, social, relational, mind/body) and two treatment domains (tolerability, environment). A literature review of published empirical research using FertiQoL was undertaken to provide an overview of this research base. Five databases were searched using ‘FertiQoL’ and its variant. In total, 41 published articles from 35 independent samples in 23 countries involving 16,315 participants, mainly in clinical settings, were reviewed. FertiQoL was used for three main purposes: (i) to assess quality of life and FertiQoL measurement properties (especially Core FertiQoL) using cross-sectional designs; (ii) to identify correlates, predictors, and consequences of fertility quality of life (some of which included international comparisons); (iii) to assess the effect of psychological interventions on fertility quality of life. The range of median FertiQoL Core, Treatment and subscale (scaled) scores in 31 samples was between 60 and 75. Poorer fertility quality of life was consistently associated with being a woman, longer duration of infertility, poorer psychological functioning and lower patient–centred care. Some FertiQoL subscale scores improved after psychological interventions. Future research should address measurement issues and examine reported associations with fertility quality of life.

Background Misleading news claims can be detrimental to public health. We aimed to improve the alignment between causal claims and evidence, without losing news interest (counter to assumptions that news is not interested in communicating caution). Methods We tested two interventions in press releases, which are the main sources for science and health news: (a) aligning the headlines and main causal claims with the underlying evidence (strong for experimental, cautious for correlational) and (b) inserting explicit statements/caveats about inferring causality. The ‘participants’ were press releases on health-related topics (N = 312; control = 89, claim alignment = 64, causality statement = 79, both = 80) from nine press offices (journals, universities, funders). Outcomes were news content (headlines, causal claims, caveats) in English-language international and national media (newspapers, websites, broadcast; N = 2257), news uptake (% press releases gaining news coverage) and feasibility (% press releases implementing cautious statements). Results News headlines showed better alignment to evidence when press releases were aligned (intention-to-treat analysis (ITT) 56% vs 52%, OR = 1.2 to 1.9; as-treated analysis (AT) 60% vs 32%, OR = 1.3 to 4.4). News claims also followed press releases, significant only for AT (ITT 62% vs 60%, OR = 0.7 to 1.6; AT, 67% vs 39%, OR = 1.4 to 5.7). The same was true for causality statements/caveats (ITT 15% vs 10%, OR = 0.9 to 2.6; AT 20% vs 0%, OR 16 to 156). There was no evidence of lost news uptake for press releases with aligned headlines and claims (ITT 55% vs 55%, OR = 0.7 to 1.3, AT 58% vs 60%, OR = 0.7 to 1.7), or causality statements/caveats (ITT 53% vs 56%, OR = 0.8 to 1.0, AT 66% vs 52%, OR = 1.3 to 2.7). Feasibility was demonstrated by a spontaneous increase in cautious headlines, claims and caveats in press releases compared to the pre-trial period (OR = 1.01 to 2.6, 1.3 to 3.4, 1.1 to 26, respectively). Conclusions News claims—even headlines—can become better aligned with evidence. Cautious claims and explicit caveats about correlational findings may penetrate into news without harming news interest. Findings from AT analysis are correlational and may not imply cause, although here the linking mechanism between press releases and news is known. ITT analysis was insensitive due to spontaneous adoption of interventions across conditions. Trial registration ISRCTN10492618 (20 August 2015) Electronic supplementary material The online version of this article (10.1186/s12916-019-1324-7) contains supplementary material, which is available to authorized users.

The Fertility Education Initiative was established in 2016 to provide education on fertility, modern families and reproductive science for young adults, teachers, health professionals, parents and adults. We report on our study to determine the feasibility and acceptability of using the arts to delivery fertility education in schools. The evaluation was mixed methods: (i) two focus groups with young people aged 14-16 and 16-18 were conducted to investigate attitudes to fertility awareness; and (ii) seventeen 16-22 year olds were divided into two groups and each undertook a day of art workshops that consisted of two visual and two theatrical workshops and then completed questionnaires at the end of each workshop and at the end of the day. The artists were interviewed using a semi-structured interview. Young adults confirmed they were interested in learning about fertility, but current understanding varied. The majority thought that fertility education should be delivered in schools at ages 16-18. During the art workshops they learnt some facts but asked for more science and discussion. They felt using art was powerful and they wanted to hear the artists personal stories. Tools using a number of platforms need to be developed that can be taken into schools nationally and evaluated for their engagement.

RESEARCH QUESTION What are the key drivers and barriers for infertile patients and their partners to see an infertility specialist and initiate treatment? DESIGN An online, international, 30-minute quantitative survey collected data from 1944 respondents from nine countries. Respondents were infertile patients (n = 1037) or partners of infertile patients (n = 907; but not necessarily partners of the patient sample), at different stages of the treatment journey. RESULTS The overall average times were 3.2 years to receiving a medical infertility diagnosis, 2.0 years attempting to achieve pregnancy without assistance before treatment, and 1.6 years of treatment before successful respondents achieved pregnancy. The most common driver for considering treatment after a consultation (n = 1025) was an equal desire within the couple to have a child (40.8%). Of the partners (n = 356), 29.8% reported that transparency of information from healthcare professionals about treatment expectations was important. A significantly higher proportion of respondents seeking treatment reported that healthcare professionals offered supportive services (61.2%) and mental health services (62.0%), than of the 207 respondents who did not seek treatment (32.4% and 36.7%, respectively; P

BackgroundWell-established risk factors for fertility problems such as smoking have been included in fertility awareness efforts globally. However, these efforts neglect risks that women in low and middle-income countries (LMIC) face.ObjectiveTo address this gap, we identified eight risk factors affecting women in LMIC and the aim of the current review was to estimate the impact of these risks on fertility.MethodsWe conducted systematic reviews and where data was available meta-analyses. We searched Medline, Embase, Cochrane library, regional databases and key organizational websites (1946-June 2016, updated January 2018, latest update taking place in 2021). Two researchers screened and extracted data independently. We included all study designs that assessed exposure to risk in clinical or community-based samples and excluded studies without control groups. The outcome of interest was fertility problems (inability to achieve pregnancy or live birth and neonatal death). We calculated pooled effect estimates from reported effect sizes or raw data. We assessed study quality using the Newcastle-Ottawa Scale. We registered the review with PROSPERO, registration number CRD42016048497.ResultsWe identified 2,418 studies and included 61 (57 in meta-analyses). Results revealed a nine-fold increased risk of inability to become pregnant in genital tuberculosis (OR 8.91, CI 1.89-42.12) and almost threefold in HIV (OR 2.93, CI 1.95-4.42) and bacterial vaginosis (OR 2.81, CI 1.85-4.27). A twofold increased risk of tubal-factor infertility in Female Genital Mutilation/Cutting–Type II/III (OR 2.06, CI 1.03-4.15) and increased post-natal mortality in consanguinity (stillbirth, OR 1.28, CI 1.04-1.57; neonatal death, OR 1.57, CI 1.22-2.02).Strength and limitationsReliability of results was bolstered by a rigorous systematic review methodology that is replicable but limited by methodological shortcomings of the available primary studies and the small number of studies in each meta-analysis.ConclusionsThe risk factors investigated appeared to impact the reproductive process through multiple biological, behavioural, and clinical pathways. Additionally, infection and pelvic inflammatory disease seemed to be common pathways for several risk factors. The complex multifactorial risk profile can be addressed by LMIC using a global health framework to determine which risk factors are significant to their populations and how to tackle them. The subsequent health promotion encompassing these relevant health indicators could translate into more prevention and effective early detection of fertility problems in LMIC. Finally, the findings of multifactorial risk reinforced the need to put fertility as an agenda in global health initiatives.

STUDY QUESTION 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? SUMMARY ANSWER 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. WHAT IS KNOWN ALREADY 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. STUDY DESIGN, SIZE, DURATION 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/MATERIALS, SETTING, METHODS 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. MAIN RESULTS AND THE ROLE OF CHANCE 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 LIMITATIONS, REASONS FOR CAUTION 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. WIDER IMPLICATIONS OF THE FINDINGS 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. STUDY FUNDING/COMPETING INTEREST(S) 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. TRIAL REGISTRATION NUMBER n/a

STUDY QUESTION Can the priorities for future research in infertility be identified? SUMMARY ANSWER The top 10 research priorities for the four areas of male infertility, female and unexplained infertility, medically assisted reproduction and ethics, access and organization of care for people with fertility problems were identified. WHAT IS KNOWN ALREADY Many fundamental questions regarding the prevention, management and consequences of infertility remain unanswered. This is a barrier to improving the care received by those people with fertility problems. STUDY DESIGN, SIZE, DURATION Potential research questions were collated from an initial international survey, a systematic review of clinical practice guidelines and Cochrane systematic reviews. A rationalized list of confirmed research uncertainties was prioritized in an interim international survey. Prioritized research uncertainties were discussed during a consensus development meeting. Using a formal consensus development method, the modified nominal group technique, diverse stakeholders identified the top 10 research priorities for each of the categories male infertility, female and unexplained infertility, medically assisted reproduction and ethics, access and organization of care. PARTICIPANTS/MATERIALS, SETTING, METHODS Healthcare professionals, people with fertility problems and others (healthcare funders, healthcare providers, healthcare regulators, research funding bodies and researchers) were brought together in an open and transparent process using formal consensus methods advocated by the James Lind Alliance. MAIN RESULTS AND THE ROLE OF CHANCE The initial survey was completed by 388 participants from 40 countries, and 423 potential research questions were submitted. Fourteen clinical practice guidelines and 162 Cochrane systematic reviews identified a further 236 potential research questions. A rationalized list of 231 confirmed research uncertainties was entered into an interim prioritization survey completed by 317 respondents from 43 countries. The top 10 research priorities for each of the four categories male infertility, female and unexplained infertility (including age-related infertility, ovarian cysts, uterine cavity abnormalities and tubal factor infertility), medically assisted reproduction (including ovarian stimulation, IUI and IVF) and ethics, access and organization of care were identified during a consensus development meeting involving 41 participants from 11 countries. These research priorities were diverse and seek answers to questions regarding prevention, treatment and the longer-term impact of infertility. They highlight the importance of pursuing research which has often been overlooked, including addressing the emotional and psychological impact of infertility, improving access to fertility treatment, particularly in lower resource settings and securing appropriate regulation. Addressing these priorities will require diverse research methodologies, including laboratory-based science, qualitative and quantitative research and population science. LIMITATIONS, REASONS FOR CAUTION We used consensus development methods, which have inherent limitations, including the representativeness of the participant sample, methodological decisions informed by professional judgment and arbitrary consensus definitions. WIDER IMPLICATIONS OF THE FINDINGS We anticipate that identified research priorities, developed to specifically highlight the most pressing clinical needs as perceived by healthcare professionals, people with fertility problems and others, will help research funding organizations and researchers to develop their future research agenda. STUDY FUNDING/COMPETING INTEREST(S) The study was funded by the Auckland Medical Research Foundation, Catalyst Fund, Royal Society of New Zealand and Maurice and Phyllis Paykel Trust. G.D.A. reports research sponsorship from Abbott, personal fees from Abbott and LabCorp, a financial interest in Advanced Reproductive Care, committee membership of the FIGO Committee on Reproductive Medicine, International Committee for Monitoring Assisted Reproductive Technologies, International Federation of Fertility Societies and World Endometriosis Research Foundation, and research sponsorship of the International Committee for Monitoring Assisted Reproductive Technologies from Abbott and Ferring. Siladitya Bhattacharya reports being the Editor-in-Chief of Human Reproduction Open and editor for the Cochrane Gynaecology and Fertility Group. J.L.H.E. reports being the Editor Emeritus of Human Reproduction. A.W.H. reports research sponsorship from the Chief Scientist’s Office, Ferring, Medical Research Council, National Institute for Health Research and Wellbeing of Women and consultancy fees from AbbVie, Ferring, Nordic Pharma and Roche Diagnostics. M.L.H. reports grants from Merck, grants from Myovant, grants from Bayer, outside the submitted work and ownership in Embrace Fertility, a private fertility company. N.P.J. reports research sponsorship from AbbVie and Myovant Sciences and consultancy fees from Guerbet, Myovant Sciences, Roche Diagnostics and Vifor Pharma. J.M.L.K. reports research sponsorship from Ferring and Theramex. R.S.L. reports consultancy fees from AbbVie, Bayer, Ferring, Fractyl, Insud Pharma and Kindex and research sponsorship from Guerbet and Hass Avocado Board. B.W.M. reports consultancy fees from Guerbet, iGenomix, Merck, Merck KGaA and ObsEva. E.H.Y.N. reports research sponsorship from Merck. C.N. reports being the Co Editor-in-Chief of Fertility and Sterility and Section Editor of the Journal of Urology, research sponsorship from Ferring and retains a financial interest in NexHand. J.S. reports being employed by a National Health Service fertility clinic, consultancy fees from Merck for educational events, sponsorship to attend a fertility conference from Ferring and being a clinical subeditor of Human Fertility. A.S. reports consultancy fees from Guerbet. J.W. reports being a statistical editor for the Cochrane Gynaecology and Fertility Group. A.V. reports that he is a Statistical Editor of the Cochrane Gynaecology & Fertility Review Group and the journal Reproduction. His employing institution has received payment from Human Fertilisation and Embryology Authority for his advice on review of research evidence to inform their ‘traffic light’ system for infertility treatment ‘add-ons’. N.L.V. reports consultancy and conference fees from Ferring, Merck and Merck Sharp and Dohme. The remaining authors declare no competing interests in relation to the present work. All authors have completed the disclosure form. TRIAL REGISTRATION NUMBER N/A.

STUDY QUESTION What are appraisals, coping strategies and emotional reactions of patients to coronavirus disease 2019 (COVID-19) fertility clinic closures? SUMMARY ANSWER 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. WHAT IS KNOWN ALREADY 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. STUDY DESIGN, SIZE, DURATION 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). PARTICIPANTS/MATERIALS, SETTING, METHODS 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. MAIN RESULTS AND THE ROLE OF CHANCE 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. LIMITATIONS, REASONS FOR CAUTION 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. WIDER IMPLICATIONS OF THE FINDINGS 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. STUDY FUNDING/COMPETING INTEREST(S) 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. TRIAL REGISTRATION NUMBER N/A.

BackgroundFear of infertility (FOI) is often reported in studies about reproductive health but this literature not yet mapped. The aim of this rapid scoping review of qualitative studies was to describe the nature of FOI in Africa.MethodsEligibility criteria were qualitative data from Africa reporting views of women and men of any age. MEDLINE and CINAHL databases were searched for English language citations to February 2019 using keywords related to fear, infertility and Africa. Two independent reviewers screened texts for inclusion.ResultsOf 248 citations identified, 38 qualitative and six review papers were included. FOI was reported in diverse groups (e.g., men, women, fertile, infertile, married, unmarried, teachers, religious leaders). Two types of fears were identified: (1) fear of triggering infertility due to specific reproductive choices and (2) fear of the dire future consequences of infertility. Choices were perceived to affect fertility via internal accumulation and blockage (e.g., of menstrual blood), structural damage (e.g., burnt eggs), internal movement of contraceptive material, deliberate toxicity preventing population growth and behavioral effects impeding sexual activity. Diverse feared consequences of infertility were reported (e.g., polygamy, economic hardships). Fears were reported to affect reproductive behaviour (e.g., stopping contraception), help-seeking and social behaviour.ConclusionFOI is a phenomenon that should be studied in its own right. Fears could originate from genuine threats, incorrect knowledge, distortions of truths, or dissemination of false information. Rigorous studies are needed to better understand FOI and integrate it in health education, client counselling and family planning service provision.

Time taken to achieve a live birth is an important consideration that is central to managing patient expectations during infertility treatment. However, time-related endpoints are not reported as standard in the majority of fertility-related clinical studies and there is no internationally recognized consensus definition for such endpoints. There is, therefore, a need for meaningful discussions around the selection of appropriate time-related treatment outcome measures for studies evaluating fertility treatments that will be relevant to diverse stakeholders (e.g. patients, healthcare professionals, clinical scientists, authorities and industry). Here, we provide a proposal for the evaluation of time-related outcome measures in fertility-related clinical studies, alongside associated definitions. ispartof: HUMAN REPRODUCTION vol:35 issue:8 pages:1732-1739 ispartof: location:England status: published

Background: Exaggerations in health news were previously found to strongly associate with similar exaggerations in press releases. Moreover such exaggerations did not appear to attract more news. Here we assess whether press release practice changed after these reported findings; simply drawing attention to the issue may be insufficient for practical change, given the challenges of media environments. Methods: We assessed whether rates of causal over-statement in press releases based on correlational data were lower following a seminal paper on the topic, compared to an equivalent baseline period in the preceding year. Results: We found that over-statements in press releases reduced from 28% (95% confidence interval = 16% to 45%) in 2014 to 13% (95% confidence interval = 6% to 25%) in 2015. A corresponding numerical reduction in exaggerations in news was not significant. The association between over-statements in news and press releases remained strong. Conclusions: Press release over-statements were less frequent following publication of Sumner et al. (2014), indicating that press release practice is malleable. However, this is correlational evidence and the reduction may be due to other factors.

STUDY QUESTION 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? SUMMARY ANSWER 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. WHAT IS KNOWN ALREADY 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. STUDY DESIGN, SIZE, DURATION 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). PARTICIPANTS/MATERIALS, SETTING, METHODS 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. MAIN RESULTS AND THE ROLE OF CHANCE 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. LIMITATIONS, REASONS FOR CAUTION 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. WIDER IMPLICATIONS OF THE FINDINGS 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. STUDY FUNDING/COMPETING INTEREST(S) 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.

[Correction Notice: An Erratum for this article was reported in Vol 23(1) of Journal of Experimental Psychology: Applied (see record 2016-59631-001). In the article, the fourth author was inadvertently omitted from the advance online version. Also, the second paragraph of the author note should have included the following: "Amy Barrington contributed to the design and data collection for Experiments 2 and 3. We thank the following undergraduate students for contributions to Experiment 1 and pilot work leading up to the project: Laura Benjamin, Cecily Donnelly, Cameron Dunlop, Rebecca Emerson, Rose Fisher, Laura Jones, Olivia Manship, Hannah McCarthy, Naomi Scott, Eliza Walwyn-Jones, Leanne Whelan, and Joe Wilton." All versions of this article have been corrected.] Science-related news stories can have a profound impact on how the public make decisions. The current study presents 4 experiments that examine how participants understand scientific expressions used in news headlines. The expressions concerned causal and correlational relationships between variables (e.g., "being breast fed makes children behave better"). Participants rated or ranked headlines according to the extent that one variable caused the other. Our results suggest that participants differentiate between 3 distinct categories of relationship: direct cause statements (e.g., "makes," "increases"), which were interpreted as the most causal; can cause statements (e.g., "can make," "can increase"); and moderate cause statements (e.g., "might cause," "linked," "associated with"), but do not consistently distinguish within the last group despite the logical distinction between cause and association. On the basis of this evidence, we make recommendations for appropriately communicating cause and effect in news headlines. (PsycINFO Database Record

Research questionIs it feasible to perform a future definitive trial to determine the effectiveness of the positive reappraisal coping intervention (PRCI) in improving the psychological well-being of women with recurrent pregnancy loss (RPL) during the early stages of a new pregnancy?DesignThis mixed method study aimed to establish the feasibility of conducting a multicentre randomized controlled trial (RCT) to definitively test the effects of the PRCI on the psychological well-being of women with RPL. Participants (n = 75) were recruited to the study and at the point of a positive pregnancy test, 47 were randomized into two study groups. The intervention group received the PRCI and weekly questionnaire assessment (Hospital Anxiety and Depression Scale and Weekly Record Keeping Form [WRK]) to monitor psychological well-being; the control group received the same questionnaires. Nested within the RCT was a qualitative process evaluation (QPE) exploring participants’ subjective experience of study methods and the intervention. The study was conducted over a two-year period between 2014 and 2016.ResultsThis study successfully gathered knowledge about the feasibility aspects of conducting a future multicentre definitive study to determine the effects of the PRCI on the psychological well-being of women with RPL. Participants were receptive to its use and the intervention appeared to convey benefits with no apparent downside.ConclusionsThe study concluded that a definitive RCT of the PRCI is possible and that the model of care already has the potential to be made more widely available as a safe, low-cost, convenient and easily deliverable intervention to provide much-needed support to a vulnerable patient population.

Background: Exaggerations in health news were previously found to strongly associate with similar exaggerations in press releases. Moreover, such press release exaggerations did not appear to attract more news. Methods: Here we tested the replicability of these findings in a new cohort of news and press releases based on research in UK universities in 2014 and 2015. Press releases and news were compared to their associated peer-reviewed articles to define exaggeration in advice, causal claims and human inference from non-human studies. Results: We found that the association between news and press releases did not replicate for advice exaggeration, while this association did replicate for causal claims and human inference from non-human studies. There was no evidence for higher news uptake for exaggerated press releases, consistent with previous results. Base exaggeration rates were lower for human inference from non-human studies, possibly reflecting the Concordat on Openness on Animal Research in the UK. Conclusions: Overall, the picture remains that the strength of news statements is normally associated with the strength of press release statements, and without evidence that exaggerated statements get significantly more news.

ObjectiveTo investigate how women experience the initial period of a new pregnancy after suffering recurrent miscarriage (RM).DesignA qualitative study, nested within a randomised controlled feasibility study of a coping intervention for RM, used semi-structured face-to-face interviews. Interviews were audio-recorded, transcribed verbatim and analysed using a thematic network approach.SettingParticipants were recruited from the Recurrent Miscarriage Clinic and Early Pregnancy Unit in two tertiary referral hospitals in the UK.Participants14 women with RMs and who had previously participated in the randomised controlled trial (RCT) feasibility component of the study were recruited.ResultsSeven organising themes emerged from the data: (1) turmoil of emotions, (2) preparing for the worst, (3) setting of personal milestones, (4) hypervigilance, (5) social isolation, (6) adoption of pragmatic approaches, (7) need for professional affirmation.ConclusionsThe study established that for women with a history of RM, the waiting period of a new pregnancy is a traumatic time of great uncertainty and emotional turmoil and one in which they express a need for emotional support. Consideration should be given to the manner in which supportive care is best delivered within the constraints of current health service provision.Trial registration numberISRCTN43571276