Improvement in pregnancy outcomes in couples with immunologically male infertility undergoing prednisolone treatment and conventional in vitro fertilization preceded by sperm penetration assay: a randomized controlled trial

Purpose Anti-sperm antibodies (ASA) in men impair not only sperm motility but also fertilization and conception. However, utilization of corticosteroids to suppress ASA has shown variable pregnancy outcomes. This controversy is also extended to include the usefulness of conventional in vitro fertilization (IVF) and intracytoplasmic sperm injection (ICSI) in treatments of men with ASA. This study was therefore designed to define factors contributing to these inconsistent results. Methods Infertile men having ASA (n = 241) were randomly assigned for treatment with or without prednisolone for three cycles each of 21 days of their partner's menstrual cycles. Control and treated men underwent then human sperm penetration assay (SPA), of hamster oocytes, to diagnose men with impaired sperm fusogenic capacity. Men with positive or negative SPA results were admitted to conventional IVF or ICSI programs, respectively. Results Treated patients had improved sperm motility and progressive motility when compared to control patients (P < 0.001). Fertilization (P = 0.04), embryo cleavage (P = 0.01), and chemical (P = 0.02) and clinical (P = 0.04) pregnancy rates were higher in treated patients than in control patients undergoing conventional IVF but not ICSI cycles. Conclusion Men with ASA may also have compromised sperm fusogenic capacity, which can mask the clinical significance of corticosteroids. Corticosteroid administration in men with ASA, but without compromised sperm fusogenic capacity, improves conventional IVF but not ICSI outcomes; the reason being that ICSI bypasses issues of compromised fusogenic capacity. Inclusion of SPA in infertility clinics that offer both conventional IVF and ICSI services may be useful to identify which patients with ASA benefit from corticosteroid treatments.