Effect of Acupuncture vs Sham Acupuncture on Live Births Among Women Undergoing In Vitro Fertilization: A Randomized Clinical Trial

This double-blind randomized controlled trial was conducted to determine whether acupuncture can improve live-birth rates in women undergoing in vitro fertilization (IVF). Published in the prestigious journal JAMA in 2018, it represents one of the largest and most rigorous studies on this topic to date, involving 848 women across 16 IVF centers in Australia and New Zealand.

The study's context arises from the widespread use of acupuncture by women undergoing IVF, despite conflicting evidence regarding its efficacy. Earlier studies had significant methodologic limitations, including small sample sizes, risk of selection bias, and heterogeneity across studies. Only five prior randomized controlled trials using sham acupuncture had reported the crucial outcome of live births, underscoring the need for a well-designed study.

The methodology was rigorously planned. Participants were women aged 18 to 42 years undergoing a fresh IVF cycle or intracytoplasmic sperm injection. The study used computer-generated randomization with the minimization method, stratified by number of prior embryo transfer cycles, woman's age, and study site. Blinding was maintained for participants, fertility specialists, nurses, and analysts.

The acupuncture protocol was developed using the Delphi method, with treatment characteristics retained when reaching 80% expert consensus. Treatment was based on traditional Chinese medicine, with points located in areas innervating the uterus and ovaries, and in areas to stimulate uterine blood flow and inhibit the stress response. The first treatment was administered between days 6 and 8 of follicular stimulation, and two treatments were given on the day of embryo transfer. Main points included Guilai ST-29, Guanyuan CV-4, Qihai CV-6, Sanyinjiao SP-6, and Xuehai SP-10, with up to 5 additional points based on the traditional Chinese medicine diagnosis.

The control group received non-invasive acupuncture using Park sham needles, which have a blunt tip and a retractable shaft. These needles were placed lightly on the skin surface without manipulation, at sham points located away from true acupuncture points.

The results were unequivocal. Among the 809 women included in the primary analysis, live births occurred in 74 of 405 women (18.3%) receiving acupuncture compared with 72 of 404 women (17.8%) receiving sham control. The risk difference was only 0.5% (95% CI: -4.9% to 5.8%), with a relative risk of 1.02 (95% CI: 0.76 to 1.38). This difference was not statistically significant (p=0.83).

Secondary outcomes showed that clinical pregnancy was achieved in 105 of 408 women (25.7%) in the acupuncture group versus 88 of 406 women (21.7%) in the sham group, a difference that was also not statistically significant. Notably, the number of spontaneous abortions was numerically higher in the acupuncture group (22.8% vs 11.6%), but without statistical significance. Adverse events were mild and acupuncture-specific, including discomfort and bruising, and were statistically more frequent in the acupuncture group.

The clinical implications are clear and important. The findings do not support the use of acupuncture to improve live-birth rates in women undergoing IVF. These results align with the American Society for Reproductive Medicine guidelines and high-quality meta-analyses concluding that acupuncture compared with sham control does not improve live-birth rates in IVF.

The study has several limitations. The planned sample size was not reached because of slow recruitment, with women seeking acupuncture in the community and declining randomization. Embryo transfer stage was not balanced between groups, with significantly more blastocyst transfers in the control group. Treatment duration was relatively short compared with usual clinical practice.

Some women were inevitably excluded from the intention-to-treat analysis because of consent withdrawal.

In conclusion, this rigorous study demonstrates that acupuncture administered during ovarian stimulation and embryo transfer does not significantly improve live-birth rates in women undergoing IVF. The findings provide high-quality evidence to guide clinical practice and patient counseling regarding complementary therapies in assisted reproduction.