Manual acupuncture for the infertile female with polycystic ovary syndrome (PCOS): study protocol for a randomized sham-controlled trial

This study is a randomized, sham-controlled, patient-and assessor-blinded trial and aims to evaluate the effect of MA in women with PCOS and infertility. We will recruit 86 women aged 20 –40 years with a diagnosis of infertility with PCOS. Participants will be randomly allocated in a 1:1 ratio to the MA group and the sham acupuncture (SA) group. Both groups will receive real herbal medicine treatment as a basic treatment twice a day for three menstrual cycles, the MA group recei ve real acupuncture treatment and the SA group received placebo acupuncture treatment (non-penetrating). All patients will receive acupuncture treatment twice per week for three menstrual cycles. The primary outcome is pregnancy rate and secondary outcomes include ovulation rate, sex hormones, insul in resistance index (IRI), PCOS symptoms, and Traditional Chinese Medicine (TCM) syndrome scores. Outcome measures will be collected at baseline, each menstrual cycle, the end of treatments, and six months after the last acupuncture treatment. The present protocol followed the SPIRIT guidelines an d fulfilled the SPIRIT checklist.DiscussionThis study will be conducted to compare the efficacy of MA versus SA. This trial will help to evaluate whether MA is effective in increasing pregnancy and ovulation rates of the infertile female with polycystic ovary syndrome.Trial registrationChinese Clinical Trial Registry,ChiCTR1800014997. Registered on 27 February 2018.
Source: Trials - Category: Research Source Type: clinical trials