Acupuncture before and during letrozole ovulation induction in women with overweight or obesity and PCOS-related infertility: a randomized sham-controlled pilot trial

Background Obesity-related metabolic dysfunction may impair fertility outcomes in women with overweight or obesity and polycystic ovary syndrome (PCOS). We evaluated acupuncture initiated 3 months before letrozole ovulation induction and continued during treatment. Methods In this single-center, randomized, participant-blinded, sham-controlled pilot trial, 60 women aged 20–35 years with a body mass index ≥25 kg/m² were assigned 1:1 to acupuncture or nonpenetrating sham acupuncture. Both groups received lifestyle guidance. Interventions were administered during the 3-month pretreatment phase and up to three letrozole cycles. The primary outcomes were continuing pregnancy and live birth. Secondary outcomes included other reproductive, anthropometric, metabolic, endometrial, and uterine artery Doppler outcomes. Results A total of 60 women were randomized, 55 completed follow-up and were included in the per-protocol analysis, while all 60 were included in the intention-to-treat analyses of pregnancy outcomes. In the per-protocol analysis, the live-birth rate was significantly higher in the acupuncture group than in the sham acupuncture group (14/27 [51.9%] vs. 6/28 [21.4%]; P = 0.03). The continuing-pregnancy rates were 14/27 (51.9%) and 8/28 (28.6%), respectively ( P = 0.10). The biochemical-pregnancy rate was also higher in the acupuncture group (17/27 [63.0%] vs. 9/28 [32.1%]; P = 0.03), whereas clinical pregnancy and pregnancy loss did not differ significantly between the groups. The intention-to-treat analyses showed similar effect directions, although the differences were not statistically significant for live birth (46.7% vs. 20.0%; P = 0.054) or continuing pregnancy (46.7% vs. 26.7%; P = 0.18). Cycle-level ovulation was summarized descriptively. Acupuncture was associated with greater improvements in body weight, glucose and lipid metabolism, insulin resistance, leptin, and adiponectin and with more favorable endometrial thickness and morphology and uterine artery Doppler indices (all P < 0.05). No serious adverse events occurred. Conclusion These preliminary findings suggest that continuous acupuncture spanning pretreatment and ovulation induction may be associated with a higher live-birth rate and improvements in metabolic and endometrial parameters. Given the exploratory nature and limited sample size of this pilot trial, confirmation in larger multicenter trials is required. Clinical trial registration https://www.chictr.org.cn/ , identifier ChiCTR2200062010.