Foshan Clinical Medical School of Guangzhou University of Chinese Medicine, Foshan, Guangdong, China.
TCM Gynecology Department, Foshan Fosun Chancheng Hospital, Foshan, Guangdong, China.
Front Endocrinol (Lausanne). 2024 Jul 22;15:1418936. doi: 10.3389/fendo.2024.1418936. eCollection 2024.
The global prevalence of infertility is 9%, with male factors potentially accounting for 40% to 60% of cases. Conventional treatments can be ineffective, invasive, costly, and linked to adverse effects and high risks. Previous studies have shown that, Chinese herbal medicine (CHM) can regulate the hypothalamus-pituitary-testis axis, improve sperm abnormalities and quality, mitigate oxidative stress, and decrease DNA fragmentation index (DFI). Yet, the evidence backing the use of Chinese herbal medicine (CHM) for treating male factor infertility lacks conviction due to study design limitations, and there remains a scarcity of studies on the live birth rate following CHM treatment for male factor infertility. Here, we describe the rationale and design of a randomized waitlist-controlled trial to evaluate the effect of CHM on the live birth rate among males with infertility.
This study is a single-center, randomized, waitlist-controlled study. A total of 250 couples diagnosed with male factor infertility will be enrolled in this study and then randomly allocated into two groups in a 1:1 ratio. Male participants in CHM group (treatment group) will receive CHM once a day for 3 months. Male participants in the waitlist group (control group) will not receive any treatment for 3 months. After 3 months, participants in both groups need to be followed up for another 12 months. The primary outcome will be the live birth rate; secondary outcomes include semen quality parameters, DFI and pregnancy related outcomes. Safety will also be assessed.
The purpose of this trial is to explore the effects and safety of CHM on the live birth rate among couples dealing with male factor infertility. The outcome of this trial may provide a viable treatment option for male factor infertility.
Chinese Clinical Trial Registry: ChiCTR2200064416. Registered on 7 October 2022, https://www.chictr.org.cn.
全球不孕症的患病率为 9%，男性因素可能占 40%至 60%的病例。传统的治疗方法可能无效、有创、昂贵，且与不良反应和高风险相关。先前的研究表明，中草药（CHM）可以调节下丘脑-垂体-睾丸轴，改善精子异常和质量，减轻氧化应激，降低 DNA 碎片指数（DFI）。然而，由于研究设计的限制，支持使用中草药（CHM）治疗男性因素不孕的证据缺乏说服力，并且关于 CHM 治疗男性因素不孕后的活产率的研究仍然很少。在这里，我们描述了一项随机等待对照试验的原理和设计，以评估 CHM 对男性不孕夫妇活产率的影响。
这是一项单中心、随机、等待对照研究。共有 250 对被诊断为男性因素不孕的夫妇将被纳入本研究，并以 1:1 的比例随机分为两组。CHM 组（治疗组）的男性参与者将每天服用 CHM 一次，持续 3 个月。等待组（对照组）的男性参与者将在 3 个月内不接受任何治疗。3 个月后，两组参与者均需再随访 12 个月。主要结局将是活产率；次要结局包括精液质量参数、DFI 和妊娠相关结局。安全性也将进行评估。
本试验的目的是探讨 CHM 对男性因素不孕夫妇活产率的影响和安全性。该试验的结果可能为男性因素不孕提供一种可行的治疗选择。
中国临床试验注册中心：ChiCTR2200064416。于 2022 年 10 月 7 日注册，网址：https://www.chictr.org.cn。
