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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.

References

[1] Carson SA, Kallen AN. Diagnosis and management of infertility: a review. Jama. 2021; 326: 65-76.

[2] Inhorn MC, Patrizio P. Infertility around the globe: new thinking on gender, reproductive technologies and global movements in the 21st century. Human Reproduction Update. 2015; 21: 411–426.

[3] Salonia A, Bettochi C, Carvalho J, Corona G, Jones TH, Kadioğlu A, et al. EAU guidelines on sexual and reproductive health 2020. European Association of Urology Guidelines 2020 Edition. European Association of Urology Guidelines Office: Arnhem, The Netherlands. 2020.

[4] Sengupta P, Dutta S, Krajewska-Kulak E. The disappearing sperms: analysis of reports published between 1980 and 2015. American Journal of Men’s Health. 2017; 11: 1279–1304.

[5] Heidary Z, Saliminejad K, Zaki-Dizaji M, Khorram Khorshid HR. Genetic aspects of idiopathic asthenozoospermia as a cause of male infertility. Human Fertility. 2020; 23: 83–92.

[6] Hanna E, Gough B. The social construction of male infertility: a qualitative questionnaire study of men with a male factor infertility diagnosis. Sociology of Health & Illness. 2020; 42: 465–480.

[7] Sylvest R, Fürbringer JK, Pinborg A, Koert E, Bogstad J, Loessl K, et al. Low semen quality and experiences of masculinity and family building. Acta Obstetricia et Gynecologica Scandinavica. 2018; 97: 727–733.

[8] Hammarberg K, Collins V, Holden C, Young K, McLachlan R. Men’s knowledge, attitudes and behaviours relating to fertility. Human Reproduction Update. 2017; 23: 458–480.

[9] Agarwal A, Sharma RK, Gupta S, Boitrelle F, Finelli R, Parekh N, et al. Sperm vitality and necrozoospermia: diagnosis, management, and results of a global survey of clinical practice. The World Journal of Men’s Health. 2022; 40: 228–242.

[10] Schlegel PN, Sigman M, Collura B, De Jonge CJ, Eisenberg ML, Lamb DJ, et al. Diagnosis and treatment of infertility in men: AUA/ASRM guideline PART II. Journal of Urology. 2021; 205: 44–51

[11] Wang SC, Wang SC, Li CJ, Lin CH, Huang HL, Tsai LM, et al. The therapeutic effects of traditional Chinese medicine for poor semen quality in infertile males. Journal of Clinical Medicine. 2018; 7: 239.

[12] Guo J. Thoughts and approaches of integrated Chinese and western medicine for the treatment of oligo-astheno-teratozoospermia. Chinese Journal of Integrative Medicine. 2018; 24: 483–486.

[13] Zhou SH, Deng YF, Weng ZW, Weng HW, Liu ZD. Traditional Chinese medicine as a remedy for male infertility: a review. The World Journal of Men’s Health. 2019; 37: 175–185.

[14] Zhao F, Deng Y, Du G, Liu S, Guo J, Wang H, et al. Network pharmacology-based strategy to investigate pharmacological mechanisms of the drug pair Astragalus-angelica for treatment of male infertility. Evidence-Based Complementary and Alternative Medicine. 2021; 2021: 8281506.

[15] Wang YN, Wang B, Liang M, Han CY, Zhang B, Cai J, et al. Down-regulation of CatSper1 channel in epididymal spermatozoa contributes to the pathogenesis of asthenozoospermia, whereas up-regulation of the channel by Sheng-Jing-San treatment improves the sperm motility of asthenozoospermia in rats. Fertility and Sterility. 2013; 99: 579–587.

[16] Yan B, Wang F, Gao QH, Zhang JW, Zhang XJ, Yu GJ, et al. Linggui Fang protects the reproductive system of asthenospermia rats: an experimental study based on the L-carnitine pathway. National Journal of Andrology. 2019; 25: 1113–1117. (In Chinese)

[17] Chan AW, Tetzlaff JM, Altman DG, Laupacis A, Gøtzsche PC, Krleža-Jerić K, et al. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Annals of Internal Medicine. 2013; 158: 200–207.

[18] Chan AW, Tetzlaff JM, Gøtzsche PC, Altman DG, Mann H, Berlin JA, et al. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013; 346: e7586.

[19] Zhang Q, Fan L, Li F, Sun Z, Zhang C, Chen R. Yishentongluo decoction in treatment of idiopathic asthenozoospermia infertility: Study protocol for a randomized controlled trial. Medicine. 2020; 99: e22662.

[20] Wang F, Gao QH, Geng Q, Han Q, Zhao JY, Yu GJ, et al. Effectiveness and safety evaluation of Qixiong Zhongzi decoction in idiopathic asthenozoospermia treatment: a randomized controlled trial. Chinese Journal of Integrative Medicine. 2020; 26: 146–151.

[21] Zhang QF, Wang S, Zhang H, Liu QL, Wei Y, Deng W, et al. Effects of alpha-lipoic acid on sperm quality in patients with varicocele-related male infertility: study protocol for a randomized controlled clinical trial. Trials. 2022; 23: 1002.

[22] Wang F, Gao QH, Geng Q, Han Q, Zhao JY, Yu GJ, et al. Erratum to: effectiveness and safety evaluation of Qixiong Zhongzi decoction in idiopathic asthenozoospermia treatment: a randomized controlled trial. Chinese Journal of Integrative Medicine. 2021; 27: 751.

[23] Li S, Zhang C, Zhang HY, Zhou M, Wang SN, Xu R, et al. Efficacy and safety of Jueyin granules for patients with mild-to-moderate psoriasis vulgaris: protocol for a multicenter randomized placebo-controlled trial. Evidence-Based Complementary and Alternative Medicine. 2020; 2020: 8942301.

[24] Hamada A, Esteves SC, Nizza M, Agarwal A. Unexplained male infertility: diagnosis and management. International Brazilian Journal of Urology. 2012; 38: 576–594.

[25] Mongioi L, Calogero AE, Vicari E, Condorelli RA, Russo GI, Privitera S, et al. The role of carnitine in male infertility. Andrology. 2016; 4: 800–807.

[26] Balercia G, Regoli F, Armeni T, Koverech A, Mantero F, Boscaro M. Placebo-controlled double-blind randomized trial on the use of l-carnitine, l-acetylcarnitine, or combined l-carnitine and l-acetylcarnitine in men with idiopathic asthenozoospermia. Fertility and Sterility. 2005; 84: 662–671.

[27] Agarwal A, Parekh N, Panner Selvam MK, Henkel R, Shah R, Homa ST, et al. Male oxidative stress infertility (MOSI): proposed terminology and clinical practice guidelines for management of idiopathic male infertility. The World Journal of Men’s Health. 2019; 37: 296–312.


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