Is methotrexate safe for men with an immune-mediated inflammatory disease and an active desire to become a father? Results of a prospective cohort study (iFAME-MTX)
Authors' conclusion
Treatment with MTX is not associated with testicular toxicity, consistent with the very low concentration of intracellular MTX-PG.
Study context
- Population
- Men ≥18 years with an immune-mediated inflammatory disease starting methotrexate (MTX), and healthy men
- Participants
- 20 vs 25
- Exposure
- MTX-starters and vs healthy controls
- MTX-startersn = 20
- Controlsn = 25reference
- Outcome
- Testicular toxicity: markers of male fertility, including semen parameters and sperm DNA fragmentation index (sDFI)
- Follow-up
- 13 weeks
Main finding
As reported in the abstract
- Pre-exposure and post-exposure semen parameters of MTX-starters not statistically significantly different
- Conventional semen parameters and sperm DNA fragmentation index (sDFI) of MTX-starters not statistically significantly different vs healthy controls
Observational data: associations, not effects.
Secondary outcomes
MTX-polyglutamates in spermatozoa and folylpolyglutamate synthetase (FPGS) enzymatic activity
- Marginal accumulation of MTX-PGs in spermatozoa, consistent with very low FPGS enzymatic activity associated with expression of an alternative FPGS splice-variant
Original publication
Is methotrexate safe for men with an immune-mediated inflammatory disease and an active desire to become a father? Results of a prospective cohort study (iFAME-MTX). Ann Rheum Dis. Published 1 June 2023. doi:10.
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