Use of ejaculated versus testicular sperm for assisted reproduction outcomes in patients with oligozoospermia in the absence of sperm DNA fragmentation testing

Objective: To compare reproductive outcomes using ejaculated versus testicular sperm as the firstline source for intracytoplasmic sperm injection (ICSI) in men with oligozoospermia without access to sperm DNA fragmentation (SDF) testing.Study Design: This was a prospective, randomized, exploratory phase II clinical trial including 44 couples allocated 1:1 to ICSI with ejaculated sperm or testicular sperm obtained by testicular sperm extraction (TESE).The primary outcome was live birth rate per started cycle.Results: Male and female partners in the TESE group were older than those in the ejaculated sperm group.Ovarian response, fertilization, and embryo development were similar between groups.Live birth occurred in 36.4% of cycles in the TESE group and 22.7% in the ejaculated sperm group, without statistical significance.TESE was not associated with a statistically significant improvement in live birth and resulted in sperm retrieval failure in 9.1% of cases. Conclusion:In this exploratory randomized phase II trial, no statistically significant difference in live birth was observed between ICSI cycles using testicular versus ejaculated sperm as the firstline sperm source in men with oligozoospermia without access to SDF testing.Interpretation of these findings should take into account baseline imbalance between groups and the limited statistical power of the study.