Off-label use of follitropin delta (recombinant FSH from human PER.C6 cell line) combined with recombinant choriogonadotropin alfa (hCG) and continued cabergoline to restore spermatogenesis in a 30-year-old male with prolactinoma-induced hypogonadotropic hypogonadism and exogenous testosterone-associated azoospermia.
After 4 months of treatment (follitropin delta 10 µg twice weekly + hCG alfa ~125 µg every 4–5 days), sperm concentration reached 3.5 million/mL (total count 4.9 million/ejaculate) from baseline azoospermia, with normalization of testosterone levels.
Single case report (n=1); no comparator arm; findings cannot be generalized without larger controlled studies.
In men with hypogonadotropic hypogonadism and azoospermia from exogenous testosterone, follitropin delta combined with hCG may restore spermatogenesis within 4 months, enabling IVF/ICSI candidacy. This is the first reported male use and should be considered experimental until confirmed in larger studies.
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