This study is a randomized assessor-blind controlled trial. A total of 1,100 women with PCOS
will be recruited from 28 hospitals and randomly allocated into four groups: personalized
acupuncture, fixed acupuncture, letrozole or placebo letrozole. Patients will receive
treatment for 16 weeks and the primary outcome is live birth.
Traditional Chinese Medicine (TCM) usually involves syndrome and disease differentiation, and
for acupuncture selection of appropriate points and skillful needling techniques. Many
clinical trials on acupuncture used fixed acupuncture protocols without accounting for
individual differences. We here design a multicenter randomized controlled trial to evaluate
whether personalized or fixed acupuncture increases the likelihood of live births for
infertility in women with polycystic ovary syndrome (PCOS) compared with letrozole or placebo
letrozole. We hypothesis that letrozole is more effective than personalized acupuncture and
that personalized acupuncture is more effective than standardized acupuncture, which is more
effective than placebo letrozole.
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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