Abstract
BackgroundIn 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 for patients with idiopathic infertility/poor semen parameters. Recent meta-analysis results suggest that a traditional Chinese medicine (TCM) formula — Wuzi Yanzong pill — showed a 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 TCM formula Wuzi Yanzong pill on improving semen qualities in men with suboptimal parameters.MethodsThis study is a double-blinded, randomized placebo-controlled trial conducted in a public hospital in Hong Kong. Participants will be randomized, using computer-generated random numbers, with a 1:1 ratio to either the Wuzi Yanzong pill formula group or the placebo group. Both groups will be administered the drugs for 12 weeks. Participants will have a total of four visits for their semen and blood assessments for a 6-month period, and we will follow up for another 6 months to record their conception outcome. The primary outcome is to compare the total motile sperm count, natural conception rate, and pregnancy outcome to those under placebo treatment. Secondary objectives are sperm functions and assisted reproductive technology outcome.DiscussionTo date, there are no studies using the disclosed Wuzi Yanzong formula or double-blinded, randomized trials. The Wuzi Yanzong TCM formula may provide a good clinical solution for subfertile males for which 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 registrationChinese Clinical Trial Registry (ChiCTR), ChiCTR-INR-17010790. Registered on 27 February 2017.Centre for Clinical Research and Biostatistics - Clinical Trials Registry, CUHK_CCRB00548. Registered on 27 February 2017.
Highlights
Subfertility is a common problem around the globe, affecting one in six couples in Hong Kong
Aim The aim of this study is to investigate the therapeutic effect of Wuzi Yanzong (WZYZ) pills on semen quality, sperm functions, and natural conception rate
One out of six couples encounters subfertility problems worldwide, and male infertility contributes to half of the cases
Summary
Background and rationale Subfertility is a common problem around the globe, affecting one in six couples in Hong Kong. Infertility is defined as failure to conceive after 1 year of regular intercourse [1, 2] Regarding semen quality, both sperm motility and concentration play important roles in achieving pregnancy. The rest of the patients (30–50%) have idiopathic infertility (infertility for unknown reasons) This latter group of males presents with no adverse history affecting fertility and has normal anatomical and physiological structure and no endocrine or chromosome abnormalities. Among these males, more than 90% of their infertility cases are due to poor sperm motility, low sperm counts, or both [3]. The aim of this study is to conduct a well-designed randomized controlled trial to investigate the effect of TCM formula Wuzi Yanzong pill on improving semen qualities in men with suboptimal parameters
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