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Trials
Published in: Trials 1/2019

Open Access 01-12-2019 | Infertility | Study protocol

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 suboptimal parameters

Authors: Mingpeng Zhao, Carol Pui Shan Chan, Cosy Wing Ching Cheung, Odai Alqawasmeh, Ronald Chi Chiu Wang, Justin Che Yuen Wu, Zhi Xiu Lin, Tin Chiu Li, Jacqueline Pui Wah Chung, Jennifer Sze Man Mak, Tracy Sze Man Law, David Yiu Leung Chan

Published in: Trials | Issue 1/2019

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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 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.

Methods

This 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.

Discussion

To 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 registration

Chinese 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.
Appendix
Available only for authorised users
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Metadata
Title
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 suboptimal parameters
Authors
Mingpeng Zhao
Carol Pui Shan Chan
Cosy Wing Ching Cheung
Odai Alqawasmeh
Ronald Chi Chiu Wang
Justin Che Yuen Wu
Zhi Xiu Lin
Tin Chiu Li
Jacqueline Pui Wah Chung
Jennifer Sze Man Mak
Tracy Sze Man Law
David Yiu Leung Chan
Publication date
01-12-2019
Publisher
BioMed Central
Published in
Trials / Issue 1/2019
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-019-3647-2

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