Comparing Live Birth Rates After Combined Intracytoplasmic Sperm Injection and Artificial Oocyte Activation Versus Intracytoplasmic Sperm Injection Alone in Women With Severe Teratospermia

What this Trial Is About

This clinical trial studies patients with severe teratospermia, a condition causing abnormal sperm shape, to compare the live birth rates between two fertility treatments intracytoplasmic sperm injection ICSI combined with artificial oocyte activation AOA versus ICSI alone. The main goal is to see if adding AOA improves the chances of live birth in these patients through a randomized controlled trial. Participants are randomly assigned to one of two groups. In the ICSIAOA group, a single sperm is injected into each egg within 4 hours after egg retrieval, then the eggs are incubated in a calcium ionophore activation solution for 10 minutes before being cultured. In the ICSI alone group, a single sperm is injected within 4 hours after egg retrieval, without the additional activation step. During the study, participants undergo ovarian stimulation to retrieve mature eggs, followed by the assigned fertilization procedure. Researchers will monitor outcomes including live birth rates one year after embryo transfer, fertilization rates, embryo quality, pregnancy markers, miscarriage rates, and birth weights. The trial includes ongoing monitoring of pregnancy status and cumulative live birth rates up to 1.5 years after randomization.

Live Birth Rate Between ICSI and AOA and ICSI Alone in Patients With Severe Teratospermia