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FDA approval phases 1, 2, and 3 clinical trials requires companies to conduct large-scale studies to determine safety and efficacy

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Some protocols combine HCG with HMG or FSH for enhanced spermatogenic effects, particularly in cases where HCG monotherapy hasn't restored adequate sperm parameters

While animal studies consistently demonstrate beneficial effects across diverse injury models and tissue types, the absence of adequately powered, controlled human clinical trials prevents definitive conclusions about efficacy in human disease