Effectiveness and Safety of Korean Medicine in Treating Female Infertility: A Prospective Multicenter Observational Study.

Abstract

Purpose: This prospective multicenter observational study aimed to systematically collect and analyze data on the characteristics, treatments, and clinical outcomes of patients receiving infertility care at Korean Medicine (KM) hospitals and clinics. The goal was to assess the current status, safety, and effectiveness of KM-based infertility treatments.

Patients and methods: A total of 106 patients undergoing infertility treatment were recruited from six university-affiliated KM hospitals and 42 KM clinics. Treatment decisions were made independently by KM physicians without additional study-specific interventions. Data from 96 patients were analyzed after excluding those who did not meet the screening criteria or withdrew consent.

Results: The average age of participants was 36.9 years, while their spouses had an average age of 39.3 years. Among the participants, 65.6% received only KM treatments, while 34.4% combined KM with conventional medical treatments. The most common cause of infertility was unexplained infertility (59.4%), and the most frequent pattern identification was Kidney Deficiency type (67.7%). Acupuncture (94.8%) and herbal medicine (93.8%), particularly Jogyeongjongok-tang decoction, were the most commonly used KM interventions. Among the analyzed participants, the clinical pregnancy rate, ongoing pregnancy rate, and live birth rate were 20.8% (95% CI, 13.9-30.0%), 70.0% (95% CI, 48.1-85.5%), and 13.5% (95% CI, 8.1-21.8%), respectively. No congenital anomalies or multiple births were reported, and no serious adverse events occurred during the study.

Conclusion: This study provides insights into the characteristics, treatment patterns, clinical outcomes, and safety of KM infertility treatments. Although the small sample size limits definitive conclusions regarding treatment effectiveness and pregnancy outcomes, these findings may serve as a foundation for future research and policy development in KM-based infertility care.