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已发表论文
在体外受精中融入中药：固肾安胎丸随机对照试验方案
Authors Xu Y, Hu X, Ai KL, Sun ZG , Song JY
Received 19 July 2025
Accepted for publication 19 November 2025
Published 25 November 2025 Volume 2025:17 Pages 4855—4866
DOI https://doi.org/10.2147/IJWH.S554939
Checked for plagiarism Yes
Review by Single anonymous peer review
Peer reviewer comments 4
Editor who approved publication: Dr Matteo Frigerio
Ying Xu,1,2 Xin Hu,1 Kai-Liang Ai,1 Zhen-Gao Sun,2 Jing-Yan Song1
1The First Clinical College, Shandong University of Traditional Chinese Medicine, Jinan, People’s Republic of China; 2Reproductive Center of Integrated Medicine, The Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Jinan, People’s Republic of China
Correspondence: Jing-Yan Song; The First Clinical College, Shandong University of Traditional Chinese Medicine, No. 42, Wen Hua Xi Road, Lixia District, Jinan, 250011, People’s Republic of China, Tel +86-0531-68901236, Email hanlingjuzei91@126.com Zhen-Gao Sun, Reproductive Center of Integrated Medicine, The Affiliated Hospital of Shandong University of Traditional Chinese Medicine, No. 42, Wen Hua Xi Road, Lixia District, Jinan, 250011, People’s Republic of China, Tel +86-0531-68901236, Email sunzhengao77@126.com
Introduction: Effective ovarian stimulation and luteal phase support (LPS) are key factors for the success of in vitro fertilization and embryo transfer (IVF-ET) The present multicenter randomized trial evaluates whether adding Gushen Antai Pill (GSATP) to standard LPS improves the ongoing pregnancy rate (OPR) in women with normal ovarian reserve (NOR) undergoing fresh embryo transfer.
Methods: This study is a multicenter, randomized, double-blind, placebo-controlled trial, taking place at 20 reproductive centers within public tertiary hospitals. We plan to enroll around 800 women who are expected to have a NOR. Participants are randomized 1:1 using a stratified block randomization method with block sizes of 4 and 6, stratified by age (< 35 vs ≥ 35 years). The primary endpoint is the OPR, with comprehensive safety evaluations also being performed. Data analysis will adhere to both intention-to-treat (ITT) and per-protocol (PP) principles to ensure robust statistical validity.
Discussion: This randomized controlled trial (RCT) aims to evaluate the effectiveness and safety of combining LPS with GSATP to improve pregnancy outcomes in women with NOR who are undergoing fresh embryo transfer. By rigorously evaluating endpoints such as OPR and early pregnancy complications, this study seeks to establish evidence for GSATP as a potential adjuvant therapy in IVF-ET protocols. The findings may offer innovative therapeutic perspectives for integrating traditional Chinese medicine (TCM) into contemporary assisted reproductive technology, particularly in enhancing implantation conditions and reducing miscarriage risks during fresh cycles.
Trial Registration: ClinicalTrials.gov, ID: NCT04872660, 05/04/2021.
Keywords: Traditional Chinese Medicine, Gushen Antai Pill, threatened miscarriage, IVF-ET, ongoing pregnancy rate
1The First Clinical College, Shandong University of Traditional Chinese Medicine, Jinan, People’s Republic of China; 2Reproductive Center of Integrated Medicine, The Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Jinan, People’s Republic of China
Correspondence: Jing-Yan Song; The First Clinical College, Shandong University of Traditional Chinese Medicine, No. 42, Wen Hua Xi Road, Lixia District, Jinan, 250011, People’s Republic of China, Tel +86-0531-68901236, Email hanlingjuzei91@126.com Zhen-Gao Sun, Reproductive Center of Integrated Medicine, The Affiliated Hospital of Shandong University of Traditional Chinese Medicine, No. 42, Wen Hua Xi Road, Lixia District, Jinan, 250011, People’s Republic of China, Tel +86-0531-68901236, Email sunzhengao77@126.com
Introduction: Effective ovarian stimulation and luteal phase support (LPS) are key factors for the success of in vitro fertilization and embryo transfer (IVF-ET) The present multicenter randomized trial evaluates whether adding Gushen Antai Pill (GSATP) to standard LPS improves the ongoing pregnancy rate (OPR) in women with normal ovarian reserve (NOR) undergoing fresh embryo transfer.
Methods: This study is a multicenter, randomized, double-blind, placebo-controlled trial, taking place at 20 reproductive centers within public tertiary hospitals. We plan to enroll around 800 women who are expected to have a NOR. Participants are randomized 1:1 using a stratified block randomization method with block sizes of 4 and 6, stratified by age (< 35 vs ≥ 35 years). The primary endpoint is the OPR, with comprehensive safety evaluations also being performed. Data analysis will adhere to both intention-to-treat (ITT) and per-protocol (PP) principles to ensure robust statistical validity.
Discussion: This randomized controlled trial (RCT) aims to evaluate the effectiveness and safety of combining LPS with GSATP to improve pregnancy outcomes in women with NOR who are undergoing fresh embryo transfer. By rigorously evaluating endpoints such as OPR and early pregnancy complications, this study seeks to establish evidence for GSATP as a potential adjuvant therapy in IVF-ET protocols. The findings may offer innovative therapeutic perspectives for integrating traditional Chinese medicine (TCM) into contemporary assisted reproductive technology, particularly in enhancing implantation conditions and reducing miscarriage risks during fresh cycles.
Trial Registration: ClinicalTrials.gov, ID: NCT04872660, 05/04/2021.
Keywords: Traditional Chinese Medicine, Gushen Antai Pill, threatened miscarriage, IVF-ET, ongoing pregnancy rate