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• W4232362017 abstract "Abstract BACKGROUND Traditional Chinese medicine (TCM) usually involves syndrome differentiation and treatment. Acupuncture, one form of TCM, requires the selection of appropriate acupoints points and needling techniques, but many clinical trials on acupuncture have used fixed acupuncture protocols without accounting for individual differences among patients. 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 to letrozole. METHODS / DESIGN The study is designed as a randomized assessor-blinded controlled trial. A total of 1,100 infertile women with PCOS will be recruited from 28 hospitals and randomly allocated into four groups: A) personalized acupuncture, B) fixed acupuncture, C) letrozole, or D) 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. The adverse events will be recorded throughout the trial. All statistical analyses will be performed using the SPSS program V.21.0 (SPSS, Chicago, Illinois, USA), and a p-value <0.05 will be considered statistically significant. DISCUSSION This study will be the first multicenter RCT to compare personalized or fixed acupuncture with letrozole or placebo letrozole on live birth in infertile women with PCOS. The findings will inform whether personalized acupuncture therapy can be considered an alternative treatment to improve the live birth rate in infertile women with PCOS." @default.
• W4232362017 created "2022-05-12" @default.
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• W4232362017 date "2020-02-06" @default.
• W4232362017 modified "2023-10-16" @default.
• W4232362017 title "A multicenter randomized trial of personalized acupuncture, fixed acupuncture, letrozole, and placebo letrozole on live birth in infertile women with polycystic ovary syndrome" @default.
• W4232362017 doi "https://doi.org/10.21203/rs.2.14021/v3" @default.
• W4232362017 hasPublicationYear "2020" @default.
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