NCT03709849

Effectiveness and Safety of Bushen Culuan Decoction for Anovulatory Infertility

Effectiveness and Safety of Bushen Culuan Decoction for Anovulatory Infertility：A Clinical Research of "Same Treatment for Different Diseases"

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 528 (estimated)
• Sponsor: Xiyuan Hospital of China Academy of Chinese Medical Sciences · Academic / Other
• Sex: Female
• Age: 21 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Anovulatory Infertility
• Abnormal Uterine Bleeding-Ovulatory Disorders
• Polycystic Ovarian Syndrome
• Hyperprolactinemia
• Luteinized Unruptured Follicle Syndrome
• Corpus Luteum Insufficiency
• Ovarian Insufficiency

Interventions

Type	Name	Description
DRUG	experimental group: Bushen Culuan Decoction and Clomiphene Citrate Tablets placebo	the same as group description including dosage, frequency and duration
DRUG	control group: Clomiphene Citrate Tablets and Bushen Culuan Decoction placebo	the same as group description including dosage, frequency and duration

Timeline

• Start date: 2019-02-01
• Primary completion: 2020-03-30
• Completion: 2020-08-31
• First posted: 2018-10-17
• Last updated: 2019-01-10