Effect of a single-dose denosumab on semen quality in infertile men (the FITMI study): study protocol for a randomized controlled trial

We describe a protocol for a planned RCT aimed at evaluating whether treatment with denosumab can improve the semen quality in infertile men selected by using serum AMH as a positive predictive biomarker. The results will provide evidence crucial for future treatment in a patient group where there is a huge unmet need.Trial registrationClinical Trials.govNCT05212337. Registered on 14 January 2022.EudraCT 2021 –003,451-42. Registered on 23 June 2021.Ethical committee H-21040145. Registered on 23 December 2021.
Source: Trials - Category: Research Source Type: clinical trials