Yishentongluo decoction in treatment of idiopathic asthenozoospermia infertility: Study protocol for a randomized controlled trial.
Yishentongluo decoction in treatment of idiopathic asthenozoospermia infertility: Study protocol for a randomized controlled trial.
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益肾通络汤治疗特发性弱精子症不孕症的随机对照试验方案。
DOI：
10.1097/md.0000000000022662
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发表时间：
2020-10-23
期刊：
影响因子：
1.6
通讯作者：
Chen R
中科院分区：
文献类型：
--
作者：
Zhang Q;Fan L;Li F;Sun Z;Zhang C;Chen R
男性面临的生育困境一直是全社会关注的焦点。特发性弱精子症（AZS）是男性不育的常见原因之一，目前缺乏针对性的治疗方法。中医药在治疗男性不育症方面已显示出潜在的益处。益肾通络汤是一种具有代表性的中药方剂，但目前尚无严格的临床试验支持其应用。因此，我们设计了一项随机对照试验，以评估YSTL对特发性AZS患者的有效性和安全性，并解释YSTL改善精子运动能力的可能作用机制。本随机对照研究将160例符合条件的患者按1：1的比例分配到益斯太尔组或左卡尼汀口服液组。治疗期为12周，随访期为4周。主要结局将是前向（活力）、精子率（%）。次要结局将包括前向（活力）+非前向（活力）精子率（%）、总有效精子计数、精子线粒体内膜电位（MMP）和配偶妊娠率（%）。安全性结局将包括心电图、血液检查（包括血常规、肝功能和肾功能）、尿常规检查和粪便常规检查。将在基线、第4、8和12周进行精液参数、精子MMP检测和所有安全性结局。将在治疗后4周评估妊娠结局。本研究将为益肾汤治疗肾虚血瘀型原发性阿兹海默症的有效性和安全性提供初步证据。此外，还将通过精子MMP试验探讨YSTL提高精子活力的可能机制。中国临床试验注册标识符ChiCTR 2000033290，于2020年5月26日注册。
The reproductive dilemma faced by men has always been the focus of the whole society. Idiopathic asthenozoospermia (AZS), as one of the common causes of male infertility, lack of specific treatment. Traditional Chinese medicine has shown potential benefits in the management of male infertility. Yishentongluo decoction (YSTL) is a representative Chinese herbal formula; however, there is still no rigorous clinical trial supporting its application. Therefore, we designed a randomized controlled trial to evaluate the efficacy and safety of YSTL for patients with idiopathic AZS and explain the possible action mechanisms of YSTL in improving sperm motility. In this randomized controlled study, a total of 160 eligible patients will be assigned to YSTL group or the Levocarnitine oral solution group in a 1:1 ratio. The treatment period will be 12 weeks and the follow-up period will last 4 weeks. The primary outcome will be the the progressive (motility), sperm rate (%). Secondary outcomes will include the progressive (motility) + non-progressive (motility) sperm rate(%), total effective sperm count, inner mitochondrial membrane potential (MMP) in spermatozoa, and spouse pregnancy rate (%). Safety outcomes will cover electrocardiogram , blood tests (including blood routine test, hepatic function, and renal function), urine routine test, and stool routine test. The semen parameters, sperm MMP test, and all the safety outcomes will be performed at the baseline, 4th, 8th and 12th week. The pregnancy outcome will be evaluated at 4 weeks after treatment. This study will provide initial evidence regarding the efficacy and safety of YSTL in the treatment of idiopathic AZS with kidney deficiency and blood stasis pattern. In addition, potential mechanisms of YSTL in improving sperm motility will be explored based on sperm MMP test. Chinese Clinical Trials Register identifier, ChiCTR2000033290, registered on 26 May 2020.