Real-world evidence analysis of the follicle-stimulating hormone use in male idiopathic infertility.

Male idiopathic infertility remains a therapeutic challenge in the couple infertility management. In this setting, an empirical treatment with follicle-stimulating hormone (FSH) is allowed, although not recommended. Twenty-one clinical trials and four meta-analyses highlighted an overall increased pregnancy rate in case of FSH administration, but the indiscriminate FSH prescription is still unsupported by clinical evidence in idiopathic infertility. This context could represent an example in which real-world data (RWD) could add useful information. From a nationwide clinical practice survey performed in Italy, emerged the clinicians' attitude to prescribe FSH in the case of impaired semen with a significant improvement of semen parameters, identifying FSH treatment as a therapeutic card in the real-life management. Although more robust data are still needed to optimize FSH treatment in male idiopathic infertility, RWD should be included in the body of evidence considered in healthcare decision-making.