IntroductionMany subfertile couples are diagnosed with (relatively) unexplained subfertility and a good prognosis. National professional guidelines (eg, the Netherlands and UK) advise ‘expectant management (EM)’ for 6–12 months, in which no interaction with healthcare staff is offered. Underpowered studies indicate that face-to-face sex-counselling increases the ongoing pregnancy rates of these couples. In patients with other conditions, web-based interactive educational programmes have the same effect on sexual functioning as face-to-face sex counselling. The ‘Pleasure&Pregnancy randomised controlled trial (RCT)’ will examine in couples with unexplained subfertility and a good prognosis whether a new web-based interactive educational programme results in a higher chance of naturally conceiving an ongoing pregnancy within 6 months as compared with EM.Methods and analysisA multicentre RCT with cost-effectiveness analysis will include heterosexual couples diagnosed with (relatively) unexplained subfertility and a good prognosis in Dutch and Belgian secondary or tertiary fertility clinics. Couples will be randomised between 6 months of EM and 6 months of the Pleasure&Pregnancy-programme. This new web-based interactive educational programme includes eight progressive modules of information (on the biology of conception and pleasurable sex) and sensate focus, couple communication and mindfulness exercises. Couples are offered interaction with their coaches via email and can take part in three moderated chat sessions with peers. The primary outcome of this RCT is the probability of naturally conceiving an ongoing pregnancy within 6 months after randomisation. Secondary outcomes include time-to-pregnancy, live birth rate, costs, sexual functioning and personal and relational well-being. Analysis will be according to intention to treat.Ethics and disseminationThis study has been approved by the Medical Ethical Committees of the Academic Medical Centre (the Netherlands) and the Leuven University Hospital (Belgium). The findings of this RCT will be disseminated through presentations at international scientific meetings and peer-reviewed publications.Trail registration numberNTR5709; Pre-results.

Abstract STUDY QUESTION Can we develop a web-based sex education programme (programme running in a web browser) that addresses the needs of subfertile couples who are advised expectant management for at least 6 months? SUMMARY ANSWER The ‘Pleasure & Pregnancy’ programme addresses couples’ needs, is likely to improve couples’ sexual functioning, and is subsequently hypothesised to improve the chance of natural pregnancy. WHAT IS KNOWN ALREADY According to professional guidelines (e.g. the Netherlands and UK) couples with unexplained subfertility and a good chance of natural pregnancy, should be advised at least 6 months of expectant management. Adherence to expectant management is challenging as couples and gynaecologist prefer a more active approach. Targeting sexuality may be useful as subfertility is a risk factor for decreased sexual functioning. STUDY DESIGN, SIZE, DURATION A novel programme was developed according to the three steps of the Medical Research Councils’ (MRC) framework. First, relevant literature was explored. Second, an interdisciplinary expert panel developed a theory (based on a systematic literature review and patient interviews) on how the chance of natural conception can be improved. Third, the expected process and outcomes were modelled. PARTICIPANTS/MATERIALS, SETTING, METHODS Two licenced clinical sexologists, two gynaecologists, a clinical embryologist and two midwife-researchers, all from Belgium and the Netherlands, proposed components for the sex education programme. PubMed was searched systematically for randomised controlled trials (RCTs) evaluating the proposed components in different patient populations. The needs of 12 heterosexual Dutch or Belgian couples who were advised expectant management were explored with in-depth interviews. The content and delivery characteristics of the novel programme were described in detail with the aid of ‘Intervention Taxonomy’. To model the outcomes, a protocol for an RCT was designed, registered and submitted for publication. MAIN RESULTS AND THE ROLE OF CHANCE To help maintain or improve sexual functioning, mainly pleasure, and hence increase pregnancy rates, the web-based Pleasure & Pregnancy programme contains a combination of psychosexual education and couple communication, mindfulness and sensate focus exercises. Information on the biology of conception and interaction with fertility clinic staff and peers were added based on couples’ needs to increase potential acceptability. LIMITATIONS AND REASON FOR CAUTION This paper outlines the development phase of a sex education programme according to the MRC-framework. Whether the Pleasure & Pregnancy programme actually is acceptable, improves sexual functioning, increases pregnancy rates and is cost-effective remains to be determined. WIDER IMPLICATIONS OF THE FINDINGS No previous interactive web-based sex education programme has aimed to increase the natural pregnancy rate of subfertile couples by targeting their sexual pleasure. The Pleasure & Pregnancy programme addresses couples’ needs and its effect on sexual functioning and pregnancy rate is plausible but remains to be demonstrated by an RCT which is currently ongoing. STUDY FUNDING/COMPETING INTEREST(S) Funding was provided by The Netherlands Organisation for Health Research and Development (ZonMw), Flanders Research Foundation and the University of Amsterdam. C.B.L. is editor-in-chief of Human Reproductionbut was blinded to all parts of the peer review process. The remaining authors have no conflict of interest to report. TRIAL REGISTRATION NUMBER Not applicable.

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STUDY QUESTION What are the experiences and the support and sexual advice needs of subfertile couples continuing to attempt natural conception after the diagnostic fertility work-up? SUMMARY ANSWER Exploration of the experiences of couples showed that couples would have appreciated fertility clinic staff embedding expectant management into the fertility clinic trajectory, supportive staff with female and male patient interactions and advice on common experiences of peers and on managing their lifestyle, distress and subfertility-related sexual challenges. WHAT IS KNOWN ALREADY Dutch and British professional guidelines advise newly diagnosed subfertile couples with a ‘good prognosis’ to continue to attempt natural conception and do not require fertility clinic staff to interact with patients. Fertility clinic staff and subfertile couples struggle to follow these guidelines as they feel an urgent need for action. Subfertile couples might benefit from sexual advice, as subfertility is negatively associated with sexual functioning, which is important for natural conception. STUDY DESIGN, SIZE, DURATION Twelve one-time in-depth interviews (2015-2017) were conducted with ten heterosexual couples and two women whose partners did not participate, then the interviews were subjected to inductive content analysis, reaching inductive thematic saturation. PARTICIPANTS/MATERIALS, SETTING, METHODS The 22 interviewees had experienced 3-18 months of expectant management after their diagnostic fertility work-up in a Belgian or a Dutch tertiary fertility clinic. The face-to-face in-depth interviews explored positive and negative experiences and unmet needs. The transcribed interviews were subjected to inductive content analysis, by two researchers discussing initial disagreements. MAIN RESULTS AND THE ROLE OF CHANCE Couples would appreciate fertility clinic staff embedding expectant management in the fertility clinic trajectory, by starting off with reassuring couples that their very thorough diagnostic fertility work-up demonstrated their good chance of natural conception, and by involving couples in deciding on the duration of expectant management and by planning the follow-up appointment after expectant management up front. Couples had encountered sexual challenges during expectant management and had an interest in sexual advice, focused on increasing pleasure and partner bonding and preventing the rise of dysfunctions. Couples agreed that a (secured) website with evidence-based, non-patronizing text and mixed media would be an appropriate format for a novel support programme. Couples were keen for interactions with fertility clinic staff which addressed both partners of subfertile couples. Couples also valued advice on managing their lifestyle and distress and would have liked information on the experiences of their peers. LIMITATIONS, REASONS FOR CAUTION Recall bias is plausible given the retrospective nature of this study. This explorative interview study was not designed for examining country or gender differences in experiences and needs but it did generate new findings on inter-country differences. WIDER IMPLICATIONS OF THE FINDINGS Rather than simply advising expectant management, fertility clinics are encouraged to offer couples who continue to attempt natural conception after their diagnostic fertility work-up, supportive patient-staff interactions with advice on common experiences of peers and on managing their lifestyle, distress and sexual challenges related to subfertility. STUDY FUNDING/COMPETING INTEREST(S) Funded by Flanders Research Foundation and the University of Amsterdam. There are no competing interests. TRIAL REGISTRATION NUMBER Not applicable.