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 < 0.05 will be considered statistically significant.

Discussion

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.

Trial registration

ClinicalTrials.gov NCT03709849. Registered on 19 November 2018.

Details

Title
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
Author
Ma, Kun 1 ; Shi, Yun 2 ; He, Junqin 3 ; Teng, Xiuxiang 4 ; Wang, Rongyu 5 ; Wang, Guohua 6 ; Yu, Yanan 7 ; Chen, Yanxia 1 ; Gong, Linjuan 1   VIAFID ORCID Logo  ; Yuan, Yuan 1 ; Zhang, Huixian 1 ; Yuan, Bochao 1 ; Zhang, Chenhui 1 

1  Xiyuan Hospital, China Academy of Chinese Medical Science, Beijing, China (GRID:grid.464481.b) (ISNI:0000 0004 4687 044X) 
2  Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, China (GRID:grid.24695.3c) (ISNI:0000 0001 1431 9176) 
3  Beijing Obstetrics and Gynecology Hospital, Capital Medical University, Beijing Maternal and Child Health Care Hospital, Beijing, China (GRID:grid.459697.0) 
4  Beijing Hospital of Traditional Chinese Medicine, Beijing, China (GRID:grid.459365.8) (ISNI:0000 0004 7695 3553) 
5  Beijing First Hospital of Integrated Chinese and Western Medicine, Beijing, China (GRID:grid.459365.8) 
6  Beijing University of Chinese Medicine Third Affiliated Hospital, Beijing, China (GRID:grid.24695.3c) (ISNI:0000 0001 1431 9176) 
7  Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing, China (GRID:grid.410318.f) (ISNI:0000 0004 0632 3409) 
Pages
563
Publication year
2022
Publication date
Dec 2022
Publisher
Springer Nature B.V.
e-ISSN
17456215
Source type
Scholarly Journal
Language of publication
English
DOI
https://doi.org/10.1186/s13063-022-06289-7
ProQuest document ID
2808567467
Copyright
© The Author(s) 2022. This work is published under http://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.