Background:To evaluate the efficacy and safety of traditional Chinese medicine formulas combined with acupuncture for the treatment of ovulation dysfunction infertility (ODI).Methods:From January 1, 2018 to March 12, 2023, 7 electronic databases, PubMed, EMBASE, Web of Science, Cochrane Library, CNKI, Wanfang Database, and CBM, were systematically searched to identify eligible randomized controlled trial studies.Results:Meta analysis showed that traditional Chinese medicine combined with acupuncture can more effectively improve sex hormone levels compared to Western medicine alone, including follicle stimulating hormone (FSH) in older patients (standardized mean difference [SMD]: 3.00; 95% confidence interval [CI]: 2.35–3.66;P= .024, I2= 28%), FSH in younger patients (SMD: 0.45; 95% CI: −0.15, 1.05;P= .03, I2= 71%), estradiol (E2) (SMD: 7.50; 95% CI: v0.47, 15.48;P< .00001, I2= 99%), and progesterone (P) (SMD: 2.20; 95% CI: 2.07–2.33;P< .00001, I2= 29%). Compared to Western medicine alone, traditional Chinese medicine combined with acupuncture also had a better effect to increase ovulation rate (risk ratio [RR]: 2.46; 95% CI: 1.72–3.52;P< .00001, I2= 0%), pregnancy rate (RR: 2.50; 95% CI: 1.96–3.18;P< .00001, I2= 0%), maximum follicle diameter (MFD) (SMD: 2.27; 95% CI: 1.37–3.16;P< .00001, I2= 91%), and endometrial thickness (SMD: 1.71; 95% CI: 1.31–2.11;P< .00001, I2= 87%). The combination of traditional Chinese medicine and acupuncture also had better effects on quality of life (RR: 0.19; 95% CI: 0.15–0.23;P< .00001, I2= 0%) and reduced adverse reactions (RR: 0.15; 95% CI: 0.05–0.48;P= .001, I2= 0%), compared to Western medicine alone.Conclusion:This study shows evidence that traditional Chinese medicine formulas combined with acupuncture are an effective and safe treatment approach. However, this conclusion requires further confirmation due to the insufficient quality of the included trials.