The Effect of Bushen Culuan Decoction on Anovulatory Infertile Women among 6 Different Diseases: A Study Protocol for a Randomized, Double-Blinded, Positive Controlled, Adaptive Multicenter Clinical Trial
Kun Ma38672, Yun Shi38673, Junqin He38674, Xiuxiang Teng38675, Rongyu Wang38676, Guohua Wang38677, Yanan Yu38678, Yanxia Chen38679, Linjuan Gong38680*, Yuan Yuan38681, Huixian Zhang38682, Bochao Yuan38683 and Chenhui Zhang38684
Background: Anovulation is one of the main causes of female infertility and 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 (PCOS), hyperprolactinemia, Luteinized Unruptured Follicle Syndrome (LUFS), corpus luteum insufficiency and Premature Ovarian Insufficiency (POI).
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.
Results and discussion: 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.
Conclusion: 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.