• Cui Jiang, Zhaodi Wang, Shiqing Yuan, Yong Jiang, and Ying Ye.
• School of Basic Medical Sciences, Chengdu University of Traditional Chinese Medicine.
• Medicine (Baltimore). 2021 Feb 5; 100 (5): e24248e24248.

BackgroundInfertility is a reproductive disorder caused by multiple causes and is an adverse event of reproductive health for couples in the reproductive period. Women who do not avoid sex for at least 12 months and are not pregnant are said to be infertile. 10% to 20% of infertility is caused by immune factors. At present, there is no unified diagnostic standard for immunological infertility. Clinically, it is considered that abnormal ovulation and reproductive system function of women are excluded, and no obvious pathogenic factors occur; routine examination of male semen is normal, but there is evidence of anti-reproductive immunity, thus causing infertility is immunological infertility. Traditional Chinese medicine (TCM) has a long history of treating infertility and has remarkable curative effect. It plays an important role in the treatment of gynecological and obstetrical diseases in China. The purpose of this study is to evaluate the efficacy and safety of traditional Chinese medicine for the treatment of immune infertility.Methodwe searched the literature from following databases: Cochrane Library, PubMed, China Biomedical Literature Database (CB), EMBASE, Chinese Journal of Science and Technology (VIP), China National Knowledge Infrastructure Database (CNKI) and Wanfang Database were searched. All the databases mentioned above will be searched from the start date to the latest version. A manual search of all references to the included trials, published randomized controlled trials (RCTs) whether blind or unblind, any languages and length of follow up were included. Treatments included Chinese medicinal herbs (single or compound). Controlls were placebo and western medicine, or no intervention. Key outcomes will include pregnancy rates, the efficiency of Chinese herbal medicine (at least one negative antibody for infertility), birth rates (the ratio of the number of pregnant women giving birth to their babies normally after herbal treatment to the total number of patients treated), recurrence rate and safety index. Two evaluators independently retrieved and extracted data and import it into Endnote X8. Then they conduct methodological evaluation on the quality of the included studies, and meta-analysis was conducted with RevMan 5.3 and Stata 13.0 software. We will use the Cochrane risk analysis tool to assess the risk of bias. Differences will be resolved by consensus or through the participation of third parties. All analysis will be performed based on the Cochrane Handbook for Systematic Reviews of Interventions.ResultsThe purpose of this study is to evaluate the efficacy and safety of traditional Chinese herb medicine in the treatment of immune infertility.ConclusionThis meta-analysis can provide evidence for clinicians to help patients make better choices.Trial Registration NumberINPLASY2020120073.Copyright © 2021 the Author(s). Published by Wolters Kluwer Health, Inc.

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