Developing couple‑centered nursing interventions for male infertility: a mixed-methods protocol

Infertility affects approximately one in six couples worldwide, with male‑factor infertility accounting for nearly half of all cases. However, men's psychosocial and relational needs remain under‑recognized, especially in cultural contexts where stigma restricts open expression.

This protocol outlines a three-phase, sequential mixed-methods study designed to develop and pilot a culturally responsive, couple-centered nursing intervention in Iran. Phase I employs grounded theory interviews with couples and key informants to identify psychosocial challenges. Phase II applies theory synthesis to construct a conceptual care model and a corresponding intervention framework. Phase III involves a two-arm randomized controlled trial to assess feasibility, acceptability, and preliminary outcomes, including fertility-related quality of life (FertiQoL), psychological well-being (WHO-5), relationship adjustment (R-DAS), and healthcare engagement.

By integrating qualitative depth with quantitative evaluation, this study addresses a critical gap in reproductive health services for men and couples. The intervention is designed to be culturally attuned yet adaptable, offering a replicable framework for advancing equitable and holistic infertility care across diverse global settings. This aligns with international calls for culturally responsive reproductive health services that explicitly address the neglected psychosocial needs of men and couples.