2.1. Study design
MAY, RECRUITMENT
The study is designed as a multi-center, prospective, randomized, double-blinded, placebo-controlled trial. We recruited participants who are scheduled IVF-ET from reproductive centers in ten tertiary hospitals. The primary study site is the Reproductive Center of Integrated Medicine of the Affiliated Hospital of the Shandong University of TCM. Patient enrollment is scheduled from May 2023 to June 2025. To ensure the consistency of the procedures in all the centers, All participating researchers will be uniformly trained. Regular communication and study visits will be performed at all study sites. In addition, meetings with all study sites will be held annually or more frequently. The study protocol is designed and written based on the SPIRIT checklist.Flow diagram of participant recruitment (AFC = antral follicle count, EZTG = Erzhi Tiangui, GnRH = gonadotrophin releasing hormone, ICSI = Intracytoplasmic sperm injection, IVF = in vitro fertilization, POR = poor ovarian response).Timetable of the study.