Investigational follicle-stimulating hormone receptor agonists for male infertility therapy.

Introduction: According to estimates by the World Health Organization, about 17.5% of the adult population - roughly 1 in 6 globally - experience infertility. The causes of male infertility remain poorly understood and have yet to be fully evaluated. Follicle-stimulating hormone (FSH) represents an available and useful therapeutic strategy for the treatment of idiopathic infertility.

Areas Covered: We provide here an overview of the molecular mechanisms by which FSH stimulates Sertoli cells and the schemes, dosages, and formulations of FSH most prescribed so far and reported in the literature. We also evaluated the possible predictor factors of the response to FSH administration and the indications of the latest guidelines on the use of FSH for the treatment of male infertility.

Expert Opinion: FSH therapy should be considered for infertile male patients with oligoasthenoteratozoospermia and normal serum FSH levels to quantitatively and qualitatively improve sperm parameters and pregnancy and birth rates. The grade of evidence is very low to low, due to the limited number of randomized controlled studies and patients available, the heterogeneity of the studies, and the limited effect size. To overcome these limitations, preclinical and clinical research is needed to evaluate the most effective dose and duration of FSH administration.