Yishentongluo decoction in treatment of idiopathic asthenozoospermia infertility: Study protocol for a randomized controlled trial

BACKGROUND: 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. METHODS: 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. DISCUSSION: 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. TRIAL REGISTRATION: Chinese Clinical Trials Register identifier, ChiCTR2000033290, registered on 26 May 2020.