Follicle‐stimulating hormone effectiveness in male idiopathic infertility: What happens in daily practice?

Abstract

Objectives: To assess the effectiveness of follicle-stimulating hormone (FSH) administration in male idiopathic infertility in a clinical setting. Methods:A retrospective real-world study was carried out, including all consecutive FSH-treated infertile men attending the Andrology Unit of Modena (Italy) from June 2015 to May 2022. Medical history, physical and andrological examinations, hormonal and seminal parameters, therapeutic management and pregnancy data were collected. The primary endpoint was the number of pregnancies obtained after FSH administration, whereas semen parameters change was the secondary outcome.Results: A total of 194 of 362 (53.6%) infertile men, eligible according to the Italian Health System regulations, were treated with FSH (mean age 37.9 ± 6.1 years). Following FSH administration (mean therapy duration 9.1 ± 7.1 months), 43 pregnancies were recorded (27.6%), of which 22 occurred naturally and 21 after assisted reproduction.A significant increase in sperm concentration (9.9 ± 12.2 vs. 18.9 ± 38.9 million/mL, p = 0.045) was detected after treatment, together with a significant increase in normozoospermia (from 1.0% to 5.1%, p = .044) and a reduction in azoospermia rate (from 9.8% to 7%, p = 0.044). Dividing the cohort in FSH-responders and non-responders, in terms of pregnancy achieved, higher sperm concentrations (15.7 ± 26.6 vs. 22.2 ± 25.7 million/mL, p = 0.033) and progressive sperm motility (18.0 ± 18.2 vs. 27.3 ± 11.3, p = 0.044) were found in pregnancy group. Conclusion:Our experience suggests that FSH, empirically administered to men with idiopathic infertility, leads to pregnancy in one out of four patients and increases sperm concentration. Although the expected limits because of a real-world data study, the number of FSH-treated patients required to achieve one pregnancy seems to be lower in clinical setting if compared to previously published data.

Gonadotropins in the Management of Couple Infertility: Toward the Rational Use of an Empirical Therapy

“…The potential FSH efficacy in idiopathic infertility has been confirmed by recent real-world data analyses, 11,18 providing new relevant information directly from the clinical practice. 44 A recent study from our group 18 showed a positive FSH effect both in terms of pregnancy rate (one preg-nancy in every four men treated), and in terms of sperm quality improvement (particularly referred to sperm number).…”

“…The potential FSH efficacy in idiopathic infertility has been confirmed by recent real-world data analyses, 11,18 providing new relevant information directly from the clinical practice. 44 A recent study from our group 18 showed a positive FSH effect both in terms of pregnancy rate (one preg-nancy in every four men treated), and in terms of sperm quality improvement (particularly referred to sperm number). 18 In this study, we evaluated the efficacy of FSH used at the same dose applied to hypogonadotropic hypogonadism routinely used in clinical practice, showing an overall efficacy higher than that in in meta-analysis, but still perfectible, confirming the need to change the aim of FSH administration, shifting from "replacement" to "overstimulatory" treatment.…”

“…7 Despite these challenges, the efficacy of FSH administration in male idiopathic infertility has been evaluated in 23 clinical trials so far. 10,11,18 The comprehensive evaluation of this approach was performed by four different meta-analyses, confirming a significant increase in pregnancy rate, both natural and after ART, in those couples in whom the man was treated with FSH. [40][41][42] However, the number needed to treat (NNT) calculated on available data is too high to justify the extensive use of FSH, at least at the dosages used so far.…”

“…44 A recent study from our group 18 showed a positive FSH effect both in terms of pregnancy rate (one preg-nancy in every four men treated), and in terms of sperm quality improvement (particularly referred to sperm number). 18 In this study, we evaluated the efficacy of FSH used at the same dose applied to hypogonadotropic hypogonadism routinely used in clinical practice, showing an overall efficacy higher than that in in meta-analysis, but still perfectible, confirming the need to change the aim of FSH administration, shifting from "replacement" to "overstimulatory" treatment. Although not designed to assess FSH efficacy in male partners of infertile couples, another multicenter Italian real-world study 32 highlighted an improvement of several semen parameters in idiopathic infertile men treated with FSH.…”

“…Male idiopathic infertility refers to a condition in which a certain degree of sperm quantity and/or quality alteration is detected, but the causative factor cannot be identified. 17 From a clinical point of view, this condition represents a real challenge for the physician, who has to cope with limited therapeutic strategies, often referring patients to ART, since a targeted etiological therapy cannot be proposed, 18 contributing to gender disparity in terms of infertility. 5 Spermatogenesis is a complex and long process that starts at puberty and requires autocrine, paracrine, and endocrine factors provided by the synergic action of FSH and intratesticular testosterone [19][20][21] (►Fig.…”