The effect of Bushen Culuan Decoction on anovulatory infertile women among 6 different diseases: a study protocol for a randomized, double-blinded, positively controlled, adaptive multicenter clinical trial

Autor: Kun Ma, Yun Shi, Junqin He, Xiuxiang Teng, Rongyu Wang, Guohua Wang, Yanan Yu, Yanxia Chen, Linjuan Gong, Yuan Yuan, Huixian Zhang, Bochao Yuan, Chenhui Zhang
Jazyk: angličtina
Rok vydání: 2022
Předmět:
Zdroj: Trials, Vol 23, Iss 1, Pp 1-12 (2022)
Druh dokumentu: article
ISSN: 1745-6215
DOI: 10.1186/s13063-022-06289-7
Popis: Abstract Background 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. Methods 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
Databáze: Directory of Open Access Journals
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