Polycystic Ovarian Syndrome Clinical Trial
Official title:
Effectiveness and Safety of Bushen Culuan Decoction for Anovulatory Infertility：A Clinical Research of "Same Treatment for Different Diseases"
This study is to evaluate the effectiveness and safety of Bushen Culuan Decoction in the treatment of anovulatory infertility, including anovulatory abnormal uterine bleeding, polycystic ovarian syndrome, hyperprolactinemia, luteinized unruptured follicle syndrome, corpus luteum insufficiency and ovarian insufficiency, through a randomised, double-blinded, double-dummy, parallel positive controlled, adaptive multicenter clinical trial.
Anovulation is one of the main causes of female infertility. Anovulatory infertility account
for a proportion of 25-30% in whole female infertility.
In western medicine, hormone induced ovulation and assisted reproduction technology are two
main ways to solve the problem and Clomiphene citrate is the first-line medication in
ovulation induction. There are many side effects being reported in the treatment with modern
medicine technique such as ovarian hyperstimulation syndrome, complication with uteroscope
and puncture egg retrieval, low pregnancy rate with high ovulation rate, potential cancer
occuring risk and offspring healthy risk.
Bushen Culuan Decoction is a traditional Chinese medicine recipe with 10 Chinese herbs
including Tusizi, Yinyanghuo, Xianmao, Xuduan, Gouqizi, Nvzhenzi, Zelan, Shengpuhuang,
Xiangfu and Chuanshanlong. Previous laboratory and exploratory clinical researches have
proved Bushen Culuan Decoction had an exactly efficacy in treating anovulatory infertility
safely.
In the first stage, the primary sample size In the study is 528. Half patients will receive
Bushen Culuan Decoction and clomiphene citrate placebo, while the other half will receive
clomiphene citrate tablets and Bushen Culuan Decoction placebo. When 1/3 of 528 patients
complete the treatment, we will analysis the treatment efficacy of 6 diseases separately, and
find which of them could be the target diseases of Bushen Culuan Decoction. Then we will
modify the sample size depending on the result in first stage, and the research will only be
processed in the target diseases being chosen. In the next stage, half patients will receive
Bushen Culuan Decoction and clomiphene citrate placebo, while the other half will receive
clomiphene citrate tablets and Bushen Culuan Decoction placebo.
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