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

Autor: Justin C Y Wu, Odai Alqawasmeh, Tracy Sze Man Law, Tin-Chiu Li, Ronald Chi Chiu Wang, Cosy Wing Ching Cheung, Zhi-Xiu Lin, David Yiu Leung Chan, Jacqueline Pui Wah Chung, Jennifer Sze Man Mak, Mingpeng Zhao, Carol Pui Shan Chan
Jazyk: angličtina
Rok vydání: 2019
Předmět:
Infertility
Male
medicine.medical_specialty
Time Factors
medicine.medical_treatment
Placebo-controlled study
Medicine (miscellaneous)
Administration
Oral
Equivalence Trials as Topic
law.invention
Male infertility
03 medical and health sciences
Semen quality
Study Protocol
0302 clinical medicine
Wuzi Yanzong pill
Traditional Chinese medicine
Randomized controlled trial
Double-Blind Method
law
Semen
Internal medicine
Medicine
Humans
Pharmacology (medical)
030212 general & internal medicine
Prospective Studies
Infertility
Male
lcsh:R5-920
Assisted reproductive technology
business.industry
Fertility Agents
Male
Subfertility
medicine.disease
Clinical trial
Semen Analysis
Fertility
Treatment Outcome
Pill
Hong Kong
business
lcsh:Medicine (General)
030217 neurology & neurosurgery
Drugs
Chinese Herbal
Tablets
Zdroj: Trials
Trials, Vol 20, Iss 1, Pp 1-7 (2019)
ISSN: 1745-6215
Popis: 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. Electronic supplementary material The online version of this article (10.1186/s13063-019-3647-2) contains supplementary material, which is available to authorized users.
Databáze: OpenAIRE
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