2.12. Ethics and consent to participate
infertility
ADVERSE EVENTS
The ethical approvals of the study have been obtained from all participating reproductive centers. EZTG formula has been used in some reproductive centers as one of the conventional treatments for infertility and applied as a complementary treatment in ART. So far, there are no adverse events related to EZTG reported. In the study, all of the medications used in IVF cycles are regular and comply with the routines. The intensity of adverse events will be categorized as light, moderate, serious, and suspected unexpected serious adverse events. Serious adverse events should be reported to the TMC immediately. Meanwhile, the blind-break process will be performed, and the trials will be discontinued. If the relationship with the trial is confirmed, we will compensate the participants accordingly according to the “Regulation on the Handling of Medical Malpractice” in China. Written informed consent is necessary from each couple as a prerequisite for the trial.