Background: Assisted reproductive technologies (ART) are essential for treating infertility but often face limited success due to issues like poor embryo implantation and low live birth rates. East Asian traditional medicine (EATM), including acupuncture and herbal medicine, may help address these challenges by improving physiological responses in ART cycles.
Objective: To evaluate the effectiveness and safety of EATM, specifically acupuncture and herbal medicine, in enhancing clinical pregnancy and live birth outcomes for women undergoing ART.
Primary study objective: To evaluate the effectiveness and safety of EATM, specifically acupuncture and herbal medicine, in enhancing clinical pregnancy and live birth outcomes for women undergoing ART.
Methods/design: This study, registered in PROSPERO (CRD42023411712), systematically searched 11 databases up to March 31, 2023. Randomized controlled trials comparing EATM interventions with control groups were included, with two authors independently extracting data and assessing methodological quality. Statistical methods such as meta-regression and subgroup analyses were used to explore heterogeneity. Meta-analysis was performed using the inverse-variance method in Stata 12.0.
Setting: The trials analyzed took place in fertility clinics across various countries, predominantly in East Asia, with some trials from Europe and North America. Most were conducted in specialized reproductive health centers.
Participants: A total of 10 776 participants (aged 29-38) from 37 randomized controlled trials. Participants included women with various infertility issues, including polycystic ovary syndrome (PCOS), bilateral tubal blockage, diminished ovarian reserve and unexplained infertility.
Intervention: Acupuncture therapies included classic body acupuncture, electro-acupuncture, laser acupuncture, and auricular acupuncture. Herbal treatments included powders, pills, granules, decoctions, and ointments derived from traditional Chinese herbal formulas such as Zishen Yutai Pills and Liuwei Dihuang Granule.
Primary outcome measures: The primary outcomes were clinical pregnancy rates (as confirmed by ultrasound) and live birth rates (defined as delivery of a living child). Secondary outcomes included embryo implantation rates (measured by ultrasound) and the incidence of adverse events.
Results: EATM interventions significantly improved clinical pregnancy rates (CPR) (Risk Ratio [RR] 1.316, 95% CI 1.171-1.480) and live birth rates (LBR) (RR 1.287, 95% CI 1.081-1.533). Herbal medicine also enhanced CPR (RR 1.184, 95% CI 1.017-1.379) and LBR (RR 1.147, 95% CI 1.010-1.303). Subgroup analyses showed true acupuncture was more effective than sham acupuncture for CPR (RR 1.218, 95% CI 1.019-1.455), while herbal medicine outperformed placebo in CPR improvement (RR 1.211, 95% CI 1.071-1.370). No significant differences were observed in adverse events (AEs) or dropout rates, indicating the interventions' safety.
Conclusions: EATM, particularly acupuncture and herbal medicine, shows promise as a complementary therapy to improve pregnancy and live birth outcomes in ART. These findings suggest potential clinical benefits in incorporating EATM into fertility treatments, though further research is warranted to optimize protocols and confirm long-term effects.