A double-blinded, randomized placebo-controlled trial on the effect of Traditional Chinese Medicine formula Wuzi Yanzong Pill on improving semen qualities in men with sub-optimal parameters

Abstract Background In Hong Kong, one of six couples is affected by subfertility problems. Male infertility contributes to half of the infertility cases. In male infertility, there is no effective treatment on patients with idiopathic infertility/poor semen parameters. Recent meta-analysis suggests that a traditional Chinese medicine formula — Wuzi Yanzong Pill showed the curative effect on male fertility. However, the heterogeneity of the studies could not draw a definitive conclusion on the therapeutic effect of this formula. The aim of this study is to conduct a well-designed randomized controlled trial to investigate the effect of Traditional Chinese Medicine formula Wuzi Yanzong Pill on improving semen qualities in men with sub-optimal parameters. Methods This study is a double-blinded, randomized placebo-controlled trial conducted in a public hospital in Hong Kong. Participants will be randomized 1:1 ration either the Wuziyanzong Pill formula group or the placebo group using the computer-generated random number. Both groups will administrate the drugs for 12 weeks. Participants will have total four visits for their semen and blood assessments for a six-month period and we will follow up for another six months to record their conception outcome. The primary outcome is to compare the total motile sperm count, natural conception rate and pregnancy outcome to that under placebo treatment. Secondary objects are sperm functions and assisted reproductive technology outcome. Discussion To date, there are none of the studies using the disclosed Wuzi Yanzong formula nor double-blinded, randomized trials. The Wuzi Yanzong TCM formula may provide a good clinical solution for subfertile males that contemporary western medicine has no cure. Therefore, a well-designed randomized trial for evaluating the effect of Wuzi Yanzong TCM formula is urgently needed. Trial registration: Chinese Clinical Trial Registry (ChiCTR), ChiCTR-INR-17010790 Registered on 27/02/2017. http://www.chictr.org.cn/showproj.aspx?proj=18356 Centre for Clinical Research and Biostatistics, Clinical Trials Registry, CUHK_CCRB00548. Registered on 27/02/2017. https://www2.ccrb.cuhk.edu.hk/registry/public/437