Abstract
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.