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Linggui Yangyuan paste for patients with male infertility: a study protocol for a multicenter, double-blind, double-dummy, randomized controlled trial

  • Sheng-jing Liu1
  • Qiang Geng2
  • Chong-fu Zhong3
  • Xu-jun Yu4
  • Zhi-ming Hong5
  • Bin Yan1
  • Fu Wang1
  • Jun Guo1,*,

1Xiyuan Hospital of China Academy of Chinese Medical Sciences, 100091 Beijing, China

2First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, 300193 Tianjin, China

3Affiliated Hospital of Shandong University of Traditional Chinese Medicine, 250001 Jinan, Shandong, China

4Chengdu Fifth People’s Hospital, 611130 Chengdu, Sichuan, China

5Shenzhen Traditional Chinese Medicine Hospital, 518033 Shenzhen, Guangdong, China

DOI: 10.22514/jomh.2023.117 Vol.19,Issue 11,November 2023 pp.67-72

Submitted: 01 April 2023 Accepted: 25 May 2023

Published: 30 November 2023

*Corresponding Author(s): Jun Guo E-mail: guojun1126@126.com

Abstract

Male infertility affects millions of men worldwide and is increasing in prevalence, with asthenozoospermia (AS) and oligoasthenozoospermia (OA) being the most frequent causes, and current treatments are limited. A previous research reported that Linggui Yangyuan paste (LGYY) enhanced sperm viability and motility, but there is a lack of multicenter, rigorous, randomized and controlled studies on its efficacy. Wuzi Yanzong oral solution (WZYZ), a traditional Chinese herbal formula, is one of the most important and first-line drugs for AS and OA in China. We designed a direct comparison of LGYY’s effectiveness and safety against WZYZ in treating male infertility, specifically AS and OA. We propose a multicenter, double-blind, double-dummy, randomized controlled trial, which is planned to recruit 162 participants with AS or OA from five centers and will randomize them into two groups, whereby the treatment group will receive intervention with LGYY and WZYZ mimetics, while the control group will receive intervention with WZYZ and LGYY mimetics. The medications will be administered twice daily for 12 weeks, followed by a 12-week follow-up. The primary outcome will be total progressive motile sperm count (TPMSC), and the secondary outcomes will be semen parameters, including semen volume, sperm concentration, total sperm count, progressive motility (PR), PR + nonprogressive motility (NP), Chinese Medicine Symptoms Score (CMSS), spouse pregnancy rate and time to pregnancy. The safety outcomes will be based on the results of routine blood and urine tests, liver and kidney function tests and electrocardiography. Overall, this study aims to provide valuable insights into the potential efficacy and safety of LGYY compared to WZYZ for male infertility (AS or OA), which could guide clinicians to an alternative drug approach to treat patients with AS or OA. This clinical trial is registered at ClinicalTrials.org under the identifier NCT05792813.


Keywords

Male infertility; Asthenozoospermia; Oligoasthenozoospermia; Randomized controlled trial; Traditional Chinese medicine; Linggui Yangyuan paste; Wuzi Yanzong oral solution; Study protocol


Cite and Share

Sheng-jing Liu,Qiang Geng,Chong-fu Zhong,Xu-jun Yu,Zhi-ming Hong,Bin Yan,Fu Wang,Jun Guo. Linggui Yangyuan paste for patients with male infertility: a study protocol for a multicenter, double-blind, double-dummy, randomized controlled trial. Journal of Men's Health. 2023. 19(11);67-72.

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