Objective: To assess the risk of major malformation in the case of paternal exposure to methotrexate (MTX) at the time of conception.
Methods: Using prospective data of our Teratology Information Service, we analyzed outcomes of paternal MTX exposure at the time of conception or up to 3 months before conception.
Results: We report on the outcomes of 42 pregnancies involving 40 men treated with MTX at the time of conception. Twenty-three men were treated for an inflammatory disease (54.8%), 9 for psoriasis (21.4%), and 8 for a malignant disease (19.0%). Weekly dosages varied between 7.5 mg and 30 mg. The pregnancies resulted in 36 live births, 3 spontaneous abortions, and 3 voluntary abortions. No congenital malformation was observed at birth.
Conclusion: Based on our results and case reports in literature, paternal MTX exposure at the time of conception does not seem to raise any major concern for offspring.