Success in male infertility trials is measured as improvement in semen parameters (count, motility, morphology), increased testosterone, or recovery of spermatogenesis permitting natural or assisted conception. Approximately 30–50% of treated men showed measurable improvement in sperm parameters within 3–6 months; however, clinically meaningful improvement (achieving WHO normal thresholds or achieving paternity) occurred in 20–35%. Response is better in men with partial spermatogenesis impairment (oligozoospermia) than complete azoospermia. Prior chemotherapy exposure negatively impacts recovery; men with testicular trauma or infection may respond better. Approximately 40–50% reported no significant change in semen parameters post-treatment.
Male infertility trials are the smallest cohort among studied conditions, reflecting disease prevalence and therapeutic complexity. Three actively recruiting studies indicate emerging clinical interest. Published data predominantly come from small preclinical and early-phase clinical series. Some trials documented improvements in semen parameters (sperm concentration, motility, morphology) following MSC infusion into testicular tissue; a few azoospermic patients recovered some spermatogenesis permitting natural conception or assisted reproduction. Testosterone levels increased in responsive cohorts, suggesting Leydig-cell regeneration. However, study heterogeneity, small sample sizes, and limited controls restrict conclusions. Mechanism studies support germ-cell niche regeneration, but direct in-vivo confirmation in humans remains incomplete. Long-term paternity outcomes are inadequately documented.
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Medically reviewed by StemCellAtlas’s editorial team with Dr Dmytro Stoyanov (Urologist · 31+ yrs clinical practice) of partner clinic Stem Plus (Sofia), against ISSCR, FDA & EMA guidance. Educational information, not medical advice; figures indicative.
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