A multicenter randomized trial of personalized acupuncture, fixed acupuncture, letrozole, and placebo letrozole on live birth in infertile women with polycystic ovary syndrome

Abstract

Background: Traditional Chinese medicine (TCM) usually involves syndrome differentiation and treatment. Acupuncture, one form of TCM, requires the selection of appropriate acupoints and needling techniques, but many clinical trials on acupuncture have used fixed acupuncture protocols without accounting for individual patient differences. We have designed a multicenter randomized controlled trial (RCT) to evaluate whether personalized or fixed acupuncture increases the likelihood of live births in infertile women with polycystic ovary syndrome (PCOS) compared with letrozole or placebo letrozole. We hypothesize that letrozole is more effective than personalized acupuncture, which in turn is more effective than fixed acupuncture, and that placebo letrozole is the least effective intervention. Moreover, we hypothesize that personalized acupuncture is more likely to reduce the miscarriage rate and the risk of pregnancy complications compared with letrozole. Methods/design: The study is designed as an assessor-blinded RCT. A total of 1100 infertile women with PCOS will be recruited from 28 hospitals and randomly allocated to 4 groups: personalized acupuncture, fixed acupuncture, letrozole, or placebo letrozole. They will receive treatment for 16 weeks, and the primary outcome is live birth. Secondary outcomes include ovulation rate, conception rate, pregnancy rate, pregnancy loss rate, changes in hormonal and metabolic parameters, and changes in quality of life scores. Adverse events will be recorded throughout the trial. All statistical analyses will be performed using IBM SPSS Statistics version 21.0 software (IBM Corp., Armonk, NY, USA), and a P value < 0.05 will be considered statistically significant.

Fertility-enhancing effect of oil-based contrast agents during hysterosalpingography and the variation of this effect within a 3-year follow-up period in infertile patients

“…(2) Other post-HSG fertility-enhancing treatments (such as ovulation stimulation and traditional Chinese medicine) might also affect the spontaneous pregnancy rate. Therefore, the influence of spontaneous pregnancy rate by oil-based contrast agents was attenuated (23)(24)(25)(26).…”

Research Trends of Acupuncture Therapy on Polycystic Ovary Syndrome: A Bibliometric Analysis

“…And the keyword “low-frequency electroacupuncture,” which existed from 2013 to 2014 with the strength of citation burst of 3.88, indicates that low-frequency electroacupuncture is the most commonly applied acupuncture therapy in the treatment of PCOS. Furthermore, more relevant randomized controlled trials have been conducted to evaluate the effects of acupuncture on improving the quality of life, ovulation rates, and insulin resistance of PCOS patients [ 22 , 45 , 46 ]. Regrettably, there is a lack of convincing evidence for the efficacy of acupuncture in treating women with PCOS [ 47 ].…”

Effects of TCM on polycystic ovary syndrome and its cellular endocrine mechanism

“…Huang S et al. found that personalized acupuncture can improve live birth rates (LBRs) in infertile women with PCOS in a multicenter RCT ( 28 ). However, in 2017 and 2018, the Journal of American Medical Association published two trial reports examining the potential effect of acupuncture on improving in vitro fertilization (IVF) or LBR in women with PCOS.…”