Xiyuan Hospital of China Academy of Chinese Medical Sciences
试验速览
- 阶段
- 早期 1 期
- 状态
- 尚未招募
- 入组人数
- 162
- 主要终点
- Change in Total progressive motile sperm count (TPMSC) from baseline to post-treatment
研究概览
简要总结
Male infertility affects millions of males worldwide and is rising in prevalence due to social and environmental conditions. Asthenozoospermia (AZS) and oligoasthenozoospermia (OA) are the major causes of male infertility. The diagnosis of male infertility has a negative effect on men's physical and psychological status, poses a threat to their social relationships, lowers self-esteem, and disrupts family harmony. At present, the treatment of ASZ and OA are all mostly empirical, including antioxidants, endocrine therapy, and anti-infection. However, there are still limitations due to inefficiencies. Linggui Yangyuan paste (LGYY), a traditional Chinese compound herbal past, had been used to treat ASZ and OA for several years at the Xiyuan Hospital of China Academy of Chinese Medical Sciences. The investigators designed this program to study the efficacy and safety of LGYY for the treatment of patients with male infertility (AZS and OA).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 22 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •The participants must meet all following criteria at the time of randomization to be eligible for recruitment :
- •Study participants met the diagnostic criteria for male infertility 1)inability to have a child after at least 1 year of marriage with regular sexual life and without using any preventive methods 2)normal fertile female partner
- •Study participants met the diagnostic criteria for AZS or OA
- •sperm concentration ≥15 × 106/ mL
- •sperm concentration <15 × 106/ mL
- •PR <32% (3) Study participants met the TCM diagnosis criteria for kidney deficiency and blood stasis (4) Men aged 22 to 45 years (5) The participants signed informed consent forms
排除标准
- •The trial exclusion criteria included any of the following:
- •infertility is caused by the inability to complete sexual intercourse, including but not limited to erectile dysfunction or ejaculatory disorders
- •with infertility caused by organic lesions of the reproductive system
- •with reproductive system infection, such as chlamydia trachomatis or mycoplasma infection
- •with palpable varicocele
- •with abnormal and clinical significance of sex hormone (FSH, LH, T)
- •complicated with liver and kidney dysfunction, severe basic diseases such as diabetes, cardiovascular and cerebrovascular diseases, mental diseases, malignant tumors, or serious organic diseases
- •with a history of allergy to any medicine or ingredients used in this study
- •receive other relevant treatment for the disease 2 weeks before treatment
研究组 & 干预措施
Experimental group
LGYY+ WZYZ mimetic
干预措施: LGYY (Drug)
Experimental group
LGYY+ WZYZ mimetic
干预措施: WZYZ mimetic (Drug)
Control group
WZYZ + LGYY mimetic
干预措施: LGYY mimetic (Drug)
Control group
WZYZ + LGYY mimetic
干预措施: WZYZ (Drug)
结局指标
主要结局
Change in Total progressive motile sperm count (TPMSC) from baseline to post-treatment
时间窗: Baseline, 12 weeks
TPMSC change from baseline to post-treatment
次要结局
- spouse pregnancy rate(Baseline, 12 weeks of treatment and 12 weeks of follow-up (24 week))
- The total sperm count change from baseline to post-treatment(Baseline, 4, 8, 12 weeks)
- sperm density change from baseline to post-treatment(Baseline, 4, 8, 12 weeks)
- PR+NP rate change from baseline to post-treatment(Baseline, 4, 8, 12 weeks)
- PR rate change from baseline to post-treatment(Baseline, 4, 8, 12 weeks)
- Chinese Medicine Symptoms Score (CMSS) change from baseline to post-treatment(Baseline, 4, 8, 12 weeks of treatment and 12 weeks of follow-up (24 week))
- semen volume change from baseline to post-treatment(Baseline, 4, 8, 12 weeks)
- time to pregnancy(Baseline, 12 weeks of treatment and 12 weeks of follow-up (24 week))