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STUDY PROTOCOL article

Front. Endocrinol.
Sec. Reproduction
Volume 15 - 2024 | doi: 10.3389/fendo.2024.1418936

The Effect of Chinese herbal medicine on Male Factor Infertility: study protocol for a randomized controlled trial

Provisionally accepted
Qidan Wen Qidan Wen 1*Huan Ying Xu Huan Ying Xu 1,2Haoxi Zou Zou Haoxi Zou Zou 1Pei Wang Pei Wang 1Xiaoyan Xing Xiaoyan Xing 1Ying Chen Ying Chen 1Qiaoling Zhu Qiaoling Zhu 2Yu Chen Yu Chen 2Minhua Tan Minhua Tan 2Miaomiao Zhang Miaomiao Zhang 2Ting Pan Ting Pan 2Yanfen Chen Yanfen Chen 1Yingju Wang Yingju Wang 1Suzhen Wu Suzhen Wu 1,2*
  • 1 Foshan Clinical Medical School of Guangzhou University of Chinese Medicine, Foshan, China
  • 2 Department of Gynecology, Foshan Fosun Chancheng Hospital, Foshan, China

The final, formatted version of the article will be published soon.

    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.Methods: 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.

    Keywords: Chinese herbal medicine, Male factor infertility, live birth rate, Semen quality, randomized controlled trial

    Received: 17 Apr 2024; Accepted: 05 Jul 2024.

    Copyright: © 2024 Wen, Xu, Zou, Wang, Xing, Chen, Zhu, Chen, Tan, Zhang, Pan, Chen, Wang and Wu. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

    * Correspondence:
    Qidan Wen, Foshan Clinical Medical School of Guangzhou University of Chinese Medicine, Foshan, China
    Suzhen Wu, Foshan Clinical Medical School of Guangzhou University of Chinese Medicine, Foshan, China

    Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.