• Ran Cheng, Qing Liu, Ying Zhu, Ying Zhao, Liuqing Yang, and Qin Zhang.
• Department of Traditional Chinese Medical Gynecology, Hangzhou TCM Hospital Affiliated to Zhejiang Chinese Medical University, Hangzhou, China.
• Medicine (Baltimore). 2022 Dec 23; 101 (51): e32419e32419.

IntroductionInfertility has become a global public health issue. In vitro fertilization and embryo transfer (IVF-ET) is widely performed as an infertility treatment. However, a significant number of infertile women continue to experience serial implantation failure, despite the high quality of the transferred embryos. Jian-Pi-An-Tai formula is an experience formula in treating threatened abortion in our team. It has also been used to treat infertile women after embryo transfer and shows superiority compared to single use of conventional western medicine. However, the of evidence on its effective in treating infertile women undergo IVF-ET is lacking.MethodsThis randomized controlled trial (RCT) will be carried out in Hangzhou TCM Hospital Affiliated to Zhejiang Chinese Medical University planning to recruit 180 infertile patients undergoing IVF-ET with the type of deficiency of both the spleen and kidney. The control group will be treated by conventional western medicine and the treatment group will use conventional western medicine plus Jian-Pi-An-Tai formula. The primary outcomes will include Embryo implantation rate, Clinical pregnancy rate, Persistent pregnancy rate; and the secondary outcomes will include TCM symptom score and reproductive hormones. Safety evaluation will be recorded during the whole study. All data in this RCT will be analyzed by SPSS 23.0 software. This study has been approved by the Research Ethics Committee of the Hangzhou TCM Hospital Affiliated to Zhejiang Chinese Medical University (2022KY130).DiscussionThe results of this RCT will contribute to provide scientific and rigorous evidence for the efficacy and safety of Jian-Pi-An-Tai formula in treating infertile women undergo IVF-ET. And the results from this RCT will be published in a relevant journal after finished.Copyright © 2022 the Author(s). Published by Wolters Kluwer Health, Inc.

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