Effectiveness of acupuncture on pregnancy outcomes in patients with repeated implantation failure after IVF-ET: study protocol for a pilot randomized controlled trial.

OBJECTIVE

Repeated implantation failure (RIF) in in vitro fertilization-embryo transfer (IVF-ET) remains a challenging clinical issue. Although acupuncture is increasingly used as an adjunctive therapy for RIF patients, robust evidence supporting its efficacy in improving pregnancy outcomes is still lacking. This pilot study therefore aims to estimate effect sizes to inform sample size calculations for future definitive trials and to assess key feasibility parameters.

DESIGN AND

METHODS

This single-center, two-arm, single-blind, randomized sham-controlled trial will enroll 100 women (50 per group) with RIF aged 25~40 years. Using a parallel-group design, participants will be randomized to receive either conventional Western medicine treatment combined with acupuncture (experimental group) or the same conventional Western medicine treatment combined with sham acupuncture (control group). Acupuncture or sham acupuncture will be administered twice weekly from day 5 of the menstrual cycle until the day before embryo transfer, with a minimum of three completed sessions, targeting acupoints with standardized techniques. The primary outcome will be embryo implantation rate, and secondary outcomes will include clinical pregnancy rate and serum biomarkers (β-human chorionic gonadotropin, luteinizing hormone, progesterone, and estradiol). Safety will be monitored through adverse event reporting.

DISCUSSION: The findings of this study will provide preliminary data to guide the design of future large-scale, multicenter randomized controlled trials. Such trials would in turn generate more definitive evidence on the efficacy of acupuncture for improving pregnancy outcomes in RIF patients undergoing IVF-ET.

CLINICAL TRIAL REGISTRATION: https://itmctr.ccebtcm.org.cn/, identifier ITMCTR2025000838.