Efficacy and Safety of the Chinese Herbal Compound TJAOA101 in Treating Diminished Ovarian Reserve: A Protocol for Multicenter, Prospective, and Pre-Post Study

作者：Yan Zhang, Jian-guo Fang, Sheng-hao Tu, Zhuo Chen, Wei Xie, Ai-yue Luo, Yan Li, Chen-chen Ren, Zeng-hui Mao, Hui Xing, Qiong-fang Wu, Zhi-ying Li, Jin-jin Zhang & Shi-xuan Wang

Zhang, Y., Fang, Jg., Tu, Sh. et al. Efficacy and Safety of the Chinese Herbal Compound TJAOA101 in Treating Diminished Ovarian Reserve: A Protocol for Multicenter, Prospective, and Pre-Post Study. CURR MED SCI 43, 284–296 (2023). https://doi.org/10.1007/s11596-023-2733-6

// Abstract

Objective

Diminished ovarian reserve (DOR) can lead to early menopause, poor fecundity, and an increased risk of disorders such as osteoporosis, cardiovascular disease, and cognitive impairment, seriously affecting the physical and mental health of women. There is still no safe and effective strategy or method to combat DOR. We have developed a novel Chinese herbal formula, Tongji anti-ovarian aging 101 (TJAOA101), to treat DOR. However, its safety and efficacy need to be further validated.

Methods

In this prospective and pre-post clinical trial, 100 eligible patients aged 18–45 diagnosed with DOR will be recruited. All participants receive TJAOA101 twice a day for 3 months. Then, comparisons before and after treatment will be analyzed, and the outcomes, including anti-mullerian hormone (AMH) and follicle-stimulating hormone (FSH) levels and the antral follicle count (AFC), the recovery rate of menopause, and the Kupperman index (KMI), will be assessed at baseline, every month during medication (the intervention period), and 1, 3 months after medication (the follow-up period). Assessments for adverse events will be performed during the intervention and follow-up periods.