A web-based interactive sex-education program versus expectant management for couples with unexplained subfertility and a good prognosis: protocol for randomized controlled trial
Dreischor, F1; Dancet , EAF2; D’Hooghe , TM3; Van Wely , M1; Laan, ETM1; Lambalk , C4; Repping, S1; Custers , IM1
1: AMC, Netherlands; 2: AMC, Netherlands/KU, Leuven; 3: KU, Leuven; 4: VUMC, Netherlands
Objective: Many couples are diagnosed with unexplained subfertility and a good prognosis (i.e. ≥30%) on naturally conceiving a child. National guidelines (e.g. Netherlands, UK) advise ‘expectant management’ (EM) for 6-12 months, without offering interaction with staff. Underpowered studies indicate that face-to-face sex counselling could increase pregnancy rates. Interactive web-based educational programs had the same effect as face-to-face sex counselling on the sexual functioning of patients with other condition. We designed a randomized controlled trial (RCT) to examine whether a new interactive web-based educational program is more effective than EM in couples with unexplained subfertility and a good prognosis. Material and Methods: The RCT compares 6-months of EM to a newly developed 6-month interactive web-based educational program aiming to maintain or improve pleasurable sex. The program includes information and eight progressive modules with sensate focus, couple communication and mindfulness exercises and interaction with coaches and peers. Ongoing pregnancy rate was selected as the as primary outcome of the RCT. Secondary outcomes include time-to-pregnancy, life birth rate, costs, sexual functioning and personal and relational wellbeing. A sample size of 582 couples per arm was calculated based on an expected effect size of 8% and drop-out rate of 10% and based on testing a two-sided effect with an alpha of 5% and a power of 80%. The study will be conducted in a consortium of Dutch and Belgian gynaecologists. Results: We expect that attaining our large sample size will be feasible. Clinics will take part as they are eagerly awaiting a care program rather than simply sending couples home. Moreover, the efforts of participating clinics have been minimized by performing all interactions with patients from the intervention arm from a centralized location. We expect patients to participate once we explain our hypothesis on improved ongoing pregnancy rates. We expect only a limited drop-out rate as the program was developed after interviewing patients on their preferences. The recruitment started in June 2016 and is expected to end in December 2019. Conclusion: A multi-centre RCT with a sample size of 1164 couples was set-up, initiated and deemed feasible given the motivation to participate of gynaecologist and patients.
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