Exploring the efficacy and safety of acupuncture versus sham acupuncture for diminished ovarian reserve: study protocol for a multicentre randomised controlled trial.

Researchers in China are conducting a large study to determine whether acupuncture can help women with diminished ovarian reserve (DOR), a condition where the ovaries have fewer eggs available than expected for a woman's age. This condition can make it difficult to conceive naturally or through fertility treatments like in vitro fertilization (IVF). The study will involve 400 women across seven hospitals in China who will be randomly assigned to receive either real acupuncture or sham acupuncture (a placebo treatment that mimics acupuncture but doesn't penetrate the skin at traditional points). Each participant will receive 36 treatment sessions over 12 weeks. Researchers will measure several important factors, including the number of antral follicles (small fluid-filled sacs in the ovaries that contain immature eggs), hormone levels related to fertility, anxiety levels, and pregnancy rates for those undergoing IVF. The main goal is to see if acupuncture increases the antral follicle count after 12 weeks of treatment. This is a study protocol, meaning the research is planned but results are not yet available. Once completed, this trial will provide important evidence about whether acupuncture is both effective and safe for women with DOR. If you're considering acupuncture for fertility concerns, it's important to work with a licensed acupuncturist who has experience treating reproductive health conditions.

This multicentre randomised controlled trial protocol describes a study evaluating acupuncture efficacy for diminished ovarian reserve (DOR). The trial will randomize 400 women across seven Chinese hospitals in a 1:1 ratio to receive either verum or sham acupuncture, with 36 sessions delivered over 12 weeks. The primary outcome measure is change in antral follicle count (AFC) from baseline to week 12. Secondary outcomes include AFC at week 24, basal FSH and AMH levels at weeks 12 and 24, Self-Rating Anxiety Scale scores, clinical pregnancy rates, and IVF embryo transfer outcomes. The study design employs appropriate blinding and sham controls to minimize bias. This represents a well-designed protocol that, upon completion, will provide Level 1 evidence regarding acupuncture's therapeutic value for DOR. The inclusion of both ovarian reserve markers and IVF outcomes strengthens clinical applicability. Safety monitoring through adverse event documentation is incorporated throughout the intervention period.