A supportive intervention on infertile couples for continuing infertility treatments: a randomized trial

Infertility affects 10-15% of couples globally, with high treatment dropout rates (22-72%) due to psychological, financial, and cultural barriers. Despite evidence supporting psychosocial interventions, few address post-failure continuation in resource-limited settings like Iran, where stigma and costs disproportionately impact adherence. The aim of this RCT was to evaluate a tailored intervention for improving treatment continuation intention, reducing infertility-related stress, and enhancing mental health among Iranian couples with prior treatment discontinuation. Parallel-group RCT (CONSORT-compliant) with block randomization (1:1 allocation, block size = 4) was done on 130 women (18–42 years) who discontinued IVF/ICSI/FET after at least one unsuccessful infertility treatment in Jahad Daneshgahi Infertility Center, Qom, Iran (June–December 2021). Primary outcome was treatment continuation intention (assessed by researcher-made questionnaire based on the Transtheoretical Model). Secondary outcomes included infertility stress (assessed by Newton’s Fertility Problem Inventory (FPI)), mental health (assessed by General Health Questionnaire-28 (GHQ-28)), and communication skills (assessed by Queendom Communication Skills Test (CSTR)). The Intervention included four weekly online sessions (psychoeducation, CBT techniques, and communication skills) plus six asynchronous modules. Controls received an assessment-only control condition. Study questionnaires were completed by participants at baseline (pre-intervention) and two weeks’ post-intervention. The intervention group showed 11.5-fold higher odds of treatment continuation (aOR = 11.49, 95% CI: 2.24–58.77, p = 0.003), with 84.2%of initially reluctant participants opting to continue vs. 28.0% in controls ( p < 0.001). There were no significant improvements in infertility stress or mental health and communication skills. While the intervention significantly improved continuation intentions, its limited psychological impact suggests that infertility-related stress in this population of treatment-discontinued couples may be more closely related to decisional conflict and motivational barriers to re-engaging with treatment than to clinical psychiatric symptoms. Cultural stigma and economic burdens emerged as critical, under-addressed dropout drivers. Brief, low-cost psychoeducation can enhance treatment adherence in high-stigma settings, but integrated financial support and culturally adapted mental health care are needed for holistic impact. Trial registration: The study is registered in the Iranian Registry of Clinical Trials with the IRCT20210516051315N1 (30/05/2021).