2.10. Data management
CRF
CRF
All the data collected in the baseline screening, or at time points during the study period, will be recorded on the day participant visit the clinic. The embryological-related data will be recorded each day from the oocyte retrieval to the embryo transfer. Follow-up in the study will continue until 1 year after randomization, or during which time a live birth is achieved or all embryos are transferred.Researchers at each reproductive center will undergo data management training to ensure the data reliability and privacy of participants. The data will be collected in compliance with the prespecified standard operating procedure. Collected data will be uniformly managed by the database of the Reproductive Center of Shandong University of Traditional Chinese Medicine. All protocol deviations or modification results should be recorded in detail and properly documented. The data will be collected, entered, and coded into a standard case report form (CRF) using the double-entry method. CRFs will be kept in locked filing cabinets. And the electronic CRFs will be kept in computers with passwords and access will only be allowed to the principal researchers. All data will be de-identified by CRFs and will be kept for 5 years. After that period, the electronic data will be removed.