Effect of acupuncture vs sham acupuncture on live births among women undergoing in vitro fertilization: a randomized clinical trial

Abstract

Acupuncture during in vitro fertilization (IVF) is a frequently used adjunctive treatment. Evidence for its efficacy is conflicting. Although early studies suggested a potential benefit in improving IVF outcomes, an increased number of randomized clinical trials (RCTs) and systematic reviews have found no statistically significant difference in clinical pregnancy or live birth rates compared with a control. Significant methodological limitations affecting the quality of evidence include selection bias, small sample sizes, significant study heterogeneity, and lack of a sham acupuncture control. These limitations highlight the need for a well-designed RCT. The aimof this single-blind, parallel-group RCTwas to determine the efficacy of acupuncture performed during IVF on live birth rates compared with a sham acupuncture control. The study was conducted at 16 IVF centers in Australia and New Zealand between June 29, 2011, and October 23, 2015, with10 months of follow-up until August 2016. A total of 848 women aged 18 to 42 years undergoing a fresh IVF were randomized: 424 each to acupuncture or a sham control.Women received the first treatment between days 6 to 8 of follicle stimulation and 2 additional treatments prior to and following embryo transfer. The sham control group received a noninsertive acupuncture needle placed away from the true acupuncture points. The primary outcome, live birth, was defined as the delivery of 1 or more living infants at more than 20 weeks' gestation or birth weight of at least 400 g. For the primary analysis, risk differences and relative risks with associated 95% confidence intervals (CIs) were calculated. After randomization, 24 women withdrew consent, leaving 824 for the final analysis. Mean patient age was 35.4 (SD, 4.3) years. Of the 824 women, 371 (45.0%) had undergone more than 2 previous IVF cycles), 607 (74%) proceeded to an embryo transfer, and 809 (98.2%) had data on live birth outcomes available. There was no difference in the frequency of live births between groups: 18.3% (74/405) in women receiving acupuncture and 17.8% (72/404) in those receiving sham control; the risk difference was 0.5% with a 95% CI of −4.9% to 5.8%, and the relative risk was 1.02, with a 95% CI of 0.76 to 1.38. These data do not support the use of acupuncture to improve the rate of live births in women undergoing IVF. There was no difference in live birth rates over 1 year among this population of women undergoing IVF administration and embryo transfer following acupuncture or sham acupuncture at the time of ovarian stimulation.