▎ACHIEVEMENTS

In a major advance for global reproductive health and clinical safety, a research team led by Prof. Fei-Yuan Hsiao of the Graduate Institute of Clinical Pharmacy, National Taiwan University College of Medicine, has presented definitive answers to a question that has long haunted diabetic men planning fatherhood: “Is it safe to take metformin while trying to conceive?”

This study—published in the prestigious British Medical Journal (BMJ)—sets a new benchmark in pharmacoepidemiology and is already being hailed as a milestone in the field. Amid rising concerns from a 2022 Danish study that linked paternal metformin use to a higher risk of congenital abnormalities, the NTU-led team went further, deeper, and broader—conducting a massive multinational analysis of more than 3 million fathers across Taiwan and Norway. The result? Reassuring; the study offered science-based clarity on a matter affecting millions worldwide.

What Makes This Study Exceptional?

What distinguished this work was its unprecedented scale and methodological rigor. Prof. Hsiao’s team seamlessly integrated three of Taiwan’s most comprehensive national datasets—including birth registrations, maternal-child health records, and National Health Insurance claims—with Norway’s internationally acclaimed registry data. Using cutting-edge methods, such as sibling comparison designs and propensity score overlap weighting, the researchers were able to filter noise, eliminate bias, and isolate the actual impact of metformin on reproductive outcomes.

The findings are as significant and far-reaching as they are timely:

Paternal metformin use during the period of sperm development is not associated with an elevated overall risk of congenital malformations. For families, this means peace of mind. For clinicians, it offers critical guidance for treating type 2 diabetes in men who plan to have children.

Student-Led, Globally Resonant

The study’s first author, Lin-Chieh Meng¹ , conducted the data mining and cross-national analysis during her exchange program at the University of Oslo, making this achievement a testament not only to NTU’s academic excellence but also to its deep global research network. The research team also included collaborators at Radboud University (Netherlands), Taipei Municipal Gan-Dau Hospital, and the University of Oslo.

This landmark publication has captured global attention—featured in over 50 major media outlets worldwide—and will likely shape clinical guidelines and public health strategies for years to come.

Significance for Global Health

At a time when more couples are postponing parenthood and the incidence of chronic illnesses are on the rise, this study provides what the world urgently needs: reassurance based on scientific clarity, clinical guidance, and real-world evidence. It’s not just a contribution to Taiwan’s growing leadership in pharmacovigilance—it’s a gift to global public health.

Supported by the National Science and Technology Council and NTU, Prof. Hsiao’s team continues to blaze trails in medication safety research, with a focus on how parental drug use affects offspring health—pioneering work that will redefine the frontiers of reproductive medicine and precision pharmacoepidemiology.