Clinical Trial

MyGENESIS-PATH: Digital Program for Donor-Conceived People

Study acronym: MyGENESIS-Path
Not Yet Recruiting
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Summary
MyGENESIS-PATH is a self-guided digital psychoeducational intervention designed to support donor-conceived adults in navigating donor-conception-related information and uncertainty, DNA testing, identity, family relationships, disclosure, stigma, and expectations concerning donors and donor siblings. This two-arm randomized pilot and feasibility trial will evaluate the feasibility and acceptability of delivering MyGENESIS-PATH and of conducting a future definitive randomized controlled trial. Sixty donor-conceived adults will be randomly allocated in a 1:1 ratio to immediate access to MyGENESIS-PATH or to a waitlist control condition. Primary feasibility outcomes will assess recruitment, completion of the 4-week follow-up assessment, completeness of psychosocial outcome data, intervention uptake and completion, and completion of the immediate post-intervention feedback assessment. Intervention acceptability, usability, perceived usefulness, relevance, emotional manageability, and potential unwanted effects will be assessed among participants allocated to MyGENESIS-PATH. Changes in perceived stress, psychological well-being, coping, and donor-conception-related identity from baseline to 4 weeks after randomization will be examined as exploratory outcomes. The study is not powered to detect definitive intervention effects.
Protocol Amendment History 7 changes
critical Primary endpoint(s) modified 2026-07-19
notable Primary completion pushed: 2026-09-30 -> 2026-10-31 2026-07-19
minor Completion pushed: 2026-10-31 -> 2026-11-30 2026-07-19
critical Primary endpoint(s) modified 2026-06-25
notable Enrollment reduced: 120 -> 60 participants 2026-06-25
notable Primary completion pushed: 2026-07-31 -> 2026-09-30 2026-06-25
minor Completion pushed: 2026-09-30 -> 2026-10-31 2026-06-25
Trial Details
NCT Number NCT07457697
Lead Sponsor Universidade do Porto
Collaborators: Fundação para a Ciência e a Tecnologia
Conditions Psychosocial Stress
Enrollment 60 participants
Start Date 2026-08-18
Primary Completion 2026-10-31 (estimated)
Study Completion 2026-11-30 (estimated)
Updated on ClinicalTrials.gov 2026-07-17