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Author Spotlight: Exploring the Long-Term Health Impacts of Intracytoplasmic Sperm Injection on Offspring
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Pregnancy Outcomes Following Paternal Methotrexate Exposure: A Systematic Review and Meta-Analysis.

Nusret Uysal1, Hüseyin Yilmaz2, Mesut Gungor2

  • 1Department of Medical Pharmacology, Marmara University School of Medicine, Istanbul, Turkey.

Birth Defects Research
|November 14, 2025
PubMed
Summary

Paternal exposure to methotrexate (MTX) before conception does not increase risks for major congenital malformations, stillbirth, or preterm birth. This systematic review offers reassurance for fetal safety in pregnancies fathered by men using MTX.

Keywords:
congenital abnormalitiesmeta‐analysismethotrexatepaternal exposurepregnancy outcome

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Area of Science:

  • Reproductive toxicology
  • Perinatal medicine
  • Pharmacology

Background:

  • Limited evidence exists regarding the safety of pregnancies fathered by men exposed to methotrexate (MTX).
  • Paternal MTX exposure prior to or at conception may pose risks to fetal development.
  • Assessing these risks is crucial for reproductive counseling and management.

Purpose of the Study:

  • To systematically review and meta-analyze the association between paternal MTX exposure and adverse pregnancy outcomes.
  • To evaluate the risk of major congenital malformations, stillbirth, and preterm birth following paternal MTX exposure.
  • To provide evidence-based guidance for managing pregnancies fathered by men exposed to MTX.

Main Methods:

  • Systematic literature search of PubMed, Web of Science, and Reprotox databases.
  • Inclusion of cohort and case-control studies with unexposed control groups; exclusion of case reports and reviews.
  • Meta-analysis of adjusted odds ratios for primary outcomes; narrative synthesis for insufficient data.

Main Results:

  • No statistically significant increased risk for major congenital malformations (aOR 1.00; 95% CI 0.62-1.61).
  • No increased risk observed for stillbirth (OR 0.85; 95% CI 0.11-6.45) or preterm birth (OR 0.95; 95% CI 0.59-1.53).
  • Qualitative review found no consistent patterns of malformations in case reports or series.

Conclusions:

  • Paternal MTX exposure before or at conception is not associated with increased risks of congenital malformations, stillbirth, or preterm birth.
  • Findings suggest fetal safety regarding these outcomes following paternal MTX exposure.
  • Provides reassurance for clinicians and patients regarding paternal MTX exposure and pregnancy outcomes.