Xiyuan Hospital, China Academy of Chinese Medical Science, Beijing, 100091, China.
Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, 100700, China.
Trials. 2022 Jul 8;23(1):563. doi: 10.1186/s13063-022-06289-7.
Anovulation is one of the main causes of female infertility. This study will evaluate the effectiveness and safety of Bushen Culuan Decoction for anovulatory infertility caused by six diseases, including anovulatory abnormal uterine bleeding, polycystic ovarian syndrome, hyperprolactinemia, luteinized unruptured follicle syndrome, corpus luteum insufficiency, and premature ovarian insufficiency.
This is a randomized, double-blinded, double-dummy, parallel, positively controlled, adaptive, multicenter clinical trial. All participants will be randomly allocated by a central randomization system to the treatment group or the control group in a 1:1 ratio. The treatment group will undergo a 14-day treatment with Bushen Culuan Decoction 13 g three times a day and a 5-day treatment with clomiphene citrate placebo tablets 50 mg once a day starting on day 5 of every menstrual period. The control group will undergo a 14-day treatment with Bushen Culuan Decoction placebo 13 g three times a day and a 5-day treatment with clomiphene citrate tablets 50 mg once a day from day 5 in every menstrual period. The whole treatment will last through 3 menstrual periods or 6 menstrual periods, depending on whether ovulation is regained in the first 3 menstrual periods. All statistical analyses will be performed in SPSS 21.0 (SPSS, Chicago, Illinois, USA), and a p value < 0.05 will be considered statistically significant.
The objective of this RCT is to evaluate whether Bushen Culuan Decoction enables a higher pregnancy rate than clomiphene citrate in women with anovulatory infertility and to identify the anovulatory diseases for which Bushen Culuan Decoction has higher effectiveness .This study has been approved by the Medical Ethics Committee of Xiyuan Hospital China Academy of Chinese Medical Sciences (No. 2017XLA037-2). The results of this study will be offered for publication in peer-reviewed journals.
ClinicalTrials.gov NCT03709849 . Registered on 19 November 2018.
排卵障碍是女性不孕的主要原因之一。本研究将评估补肾促排卵汤治疗六种疾病引起的排卵障碍性不孕的有效性和安全性，包括排卵性异常子宫出血、多囊卵巢综合征、高催乳素血症、未破裂卵泡黄素化综合征、黄体功能不全和卵巢早衰。
这是一项随机、双盲、双模拟、平行、阳性对照、适应性、多中心临床试验。所有参与者将通过中央随机系统以 1:1 的比例随机分配到治疗组或对照组。治疗组在每个月经周期的第 5 天开始，每天服用补肾促排卵汤 13g，分 3 次服用，同时每天服用枸橼酸氯米酚安慰剂片 50mg，共 14 天；对照组在每个月经周期的第 5 天开始，每天服用补肾促排卵汤安慰剂 13g，分 3 次服用，同时每天服用枸橼酸氯米酚片 50mg，共 14 天。整个治疗过程持续 3 个或 6 个月经周期，具体取决于在前 3 个月经周期中是否恢复排卵。所有统计分析将在 SPSS 21.0（SPSS，芝加哥，伊利诺伊州，美国）中进行，p 值<0.05 将被认为具有统计学意义。
本 RCT 的目的是评估补肾促排卵汤是否比枸橼酸氯米酚在排卵障碍性不孕患者中具有更高的妊娠率，并确定补肾促排卵汤在哪些排卵障碍性疾病中更有效。本研究已获得中国中医科学院西苑医院医学伦理委员会的批准（编号：2017XLA037-2）。本研究的结果将发表在同行评议的期刊上。
ClinicalTrials.gov NCT03709849。于 2018 年 11 月 19 日注册。
