Angel Elenkov, Elin Wirestrand, Agnes Hagsund, Ilpo Huhtaniemi, Yvonne Lundberg Giwercman, Aleksander Giwercman
Journal: Andrology 2023;11(3):471-477
PMID: 36451611
FSH receptors have been found in many tissues outside the testes, raising concern about possible harmful off-target effects of FSH treatment beyond its intended reproductive action. FSH is increasingly being used to treat male fertility, but the non-reproductive effects of this are unclear. This small randomised controlled study investigated the non-reproductive effects of follicle-stimulating hormone (FSH) in young men. The research involved 33 healthy young men (mean age 30 years), with 16 receiving FSH injections and 17 serving as a control group.
The results initially showed some differences between the FSH-treated group and the control group: the FSH group had higher levels of proteins that influence hormone production at three weeks, and lower liver function and magnesium at five weeks. However, statistical tests showed none of these differences remained statistically significant. Thus, the study did not find confirmed significant non-reproductive effects of FSH treatment in healthy young men.
In conclusion, the findings did not show statistically significant non-reproductive effects of FSH treatment in healthy young men. While some initial differences in SHBG, albumin, liver enzyme, and magnesium levels were observed, none were confirmed once statistical rigour was applied. This provides some preliminary reassurance that short-term FSH treatment may not produce major systemic off-target effects in otherwise healthy young men. Healthcare professionals prescribing FSH for male infertility may find these findings modestly reassuring, but should be aware that the study was small and short (five weeks).
OBJECTIVE
Follicle-stimulating hormone (FSH) receptor expression has been reported in many extra-gonadal tissues, raising the question of non-reproductive effects of FSH. Because of increasing usage of FSH in treatment of male infertility, deeper knowledge of possible harmful off-target effects of FSH is warranted.
METHODS
In total, 33 healthy young men (mean age 30 years) were included in the study. All received an s.c. injection of gonadotropin-releasing hormone (GnRH) antagonist and n = 16 were randomized to 300 IU recombinant FSH (300 IE 3 times/week) for 5 weeks at first visit (V1) whereas n = 17 served as controls. Blood samples were taken at (V1), after 3 weeks (V2), and after 5 weeks (V3), when the study ended. At V2, all subjects received 1000 mg testosterone undecanoate i.m. A standard set of bio- and inflammatory markers were compared between the groups using the Mann-Whitney test adjusted for multiple testing.
RESULTS
As compared to controls, the FSH treated men had higher SHBG and albumin concentrations at V2 (p = 0.024 and 0.027, respectively), and lower levels of alanine aminotransferase (p = 0.026) and magnesium (p = 0.028) at V3. However, none of the results remained statistically significant after Bonferroni correction (p > 0.0011).
CONCLUSIONS
FSH had no significant effects on non-reproductive organs when given in standard therapeutic doses to young men for 5 weeks. Therefore, the FSH treatment can be considered safe in otherwise healthy young men, constituting candidates for the infertility treatment with FSH.
© 2022 The Authors. Andrology published by Wiley Periodicals LLC on behalf of American Society of Andrology and European Academy of Andrology.
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