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Clinical study of Wuwei Fuzheng Yijing formula in the treatment of sperm DNA damage in male infertility: A study protocol for a randomized controlled trial.
Li, Ninghua; Zhang, Chenming; Wang, Zulong; Zhang, Qi; Chen, Rubing; Hua, Zhong; Zhao, Shizhong; Shen, Huiyuan; Chang, Guifeng; Wan, Wenxi.
Afiliação
  • Li N; College of the First Clinical Medicine, Henan University of Traditional Chinese Medicine, Zhengzhou, Henan Province, P.R. China.
  • Zhang C; College of the Second Clinical Medicine, Henan University of Traditional Chinese Medicine, Zhengzhou, Henan Province, P.R. China.
  • Wang Z; The First Affiliated Hospital of Henan University of Traditional Chinese Medicine, Zhengzhou, Henan Province, P.R. China.
  • Zhang Q; The First Affiliated Hospital of Henan University of Traditional Chinese Medicine, Zhengzhou, Henan Province, P.R. China.
  • Chen R; The First Affiliated Hospital of Henan University of Traditional Chinese Medicine, Zhengzhou, Henan Province, P.R. China.
  • Hua Z; College of the Second Clinical Medicine, Henan University of Traditional Chinese Medicine, Zhengzhou, Henan Province, P.R. China.
  • Zhao S; College of the First Clinical Medicine, Henan University of Traditional Chinese Medicine, Zhengzhou, Henan Province, P.R. China.
  • Shen H; College of the First Clinical Medicine, Henan University of Traditional Chinese Medicine, Zhengzhou, Henan Province, P.R. China.
  • Chang G; College of the First Clinical Medicine, Henan University of Traditional Chinese Medicine, Zhengzhou, Henan Province, P.R. China.
  • Wan W; College of the First Clinical Medicine, Henan University of Traditional Chinese Medicine, Zhengzhou, Henan Province, P.R. China.
Medicine (Baltimore) ; 101(43): e31226, 2022 Oct 28.
Article em En | MEDLINE | ID: mdl-36316921
BACKGROUND: The incidence of male infertility is increasing in recent years, and the semen routine examination of some patients is normal, but the semen pathological examination shows that the sperm DNA fragmentation index (DFI) is high, and the patients' clinical manifestations are infertility or recurrent abortion of their spouses. At present, there is no special treatment for male infertility caused by high DFI, and traditional Chinese medicine compound prescription shows potential value in the treatment of male infertility. Wuwei Fuzheng Yijing formula (WFY) is an effective prescription for the treatment of sperm DNA damage in male infertility, but there is no strict clinical trial to support its application. Therefore, we designed a randomized controlled trial to evaluate the efficacy and safety of WFY in patients with sperm DNA damage in male infertility. METHODS: In this randomized controlled study, 100 patients who met the inclusion criteria were randomly divided into WFY group and levocarnitine oral solution group. The treatment period was 12 weeks. The main observation index was sperm DFI, and the secondary observation index was sperm concentration, motility, survival rate, and TCM syndrome score. Safety observation indicators will include electrocardiogram, blood tests (including blood routine tests, liver and renal function), routine urine tests, and routine stool tests. All results were evaluated at the 4th and 8th week of the baseline, and the end of treatment. DISCUSSION: This study will provide a basis for the efficacy and safety of WFY in the treatment of sperm DNA damage in male infertility with spleen and kidney qi deficiency and blood stasis.
Assuntos

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Sêmen / Infertilidade Masculina Tipo de estudo: Clinical_trials / Guideline Limite: Female / Humans / Male / Pregnancy Idioma: En Revista: Medicine (Baltimore) Ano de publicação: 2022 Tipo de documento: Article

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Sêmen / Infertilidade Masculina Tipo de estudo: Clinical_trials / Guideline Limite: Female / Humans / Male / Pregnancy Idioma: En Revista: Medicine (Baltimore) Ano de publicação: 2022 Tipo de documento: Article