Methodological Challenges and Lessons Learned from the Multi-Centre Randomised Controlled Moda Trial (Modified Downregulation in Women with Moderate/Severe Adenomyosis Undergoing Frozen Embryo Transfer)

Abstract

The MODA trial is a multi-centre, randomised controlled trial designed to investigate the effectiveness of modified downregulation with gonadotropin-releasing hormone analogues prior to frozen embryo transfer in women with moderate to severe adenomyosis. Adenomyosis is a poorly studied condition associated with subfertility and adverse reproductive outcomes. This methodological paper describes the challenges and lessons learned during the design and implementation of the MODA trial, including defining eligibility criteria, optimising diagnostic methods, managing co-existing endometriosis, recruitment, and trial delivery across multiple centres. We share solutions implemented to address these challenges to inform future trials in reproductive medicine in complex patient populations such as women with adenomyosis undergoing in vitro fertilisation treatment.

Note:
Funding declaration: None declared

Conflict of Interests: None declared.

Ethical Approval: Ethical approval has been obtained and the trial is registered with ISRCTN (NCT03946722).

Trial registration: ISRCTN (NCT03946722)

Keywords: Infertility, in vitro fertilisation, adenomyosis, downregulation, randomised-controlled trial