Reproductive Medicine Centre, Skane University Hospital Malmo, Malmö, Sweden.
Department of Translational Medicine, Lund University, Lund, Sweden.
Andrology. 2023 Mar;11(3):471-477. doi: 10.1111/andr.13335. Epub 2023 Jan 12.
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.
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.
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).
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.
已报道卵泡刺激素(FSH)受体在许多性腺外组织中表达,这引发了 FSH 是否具有非生殖作用的问题。由于 FSH 在男性不育治疗中的应用日益增多,因此更深入地了解 FSH 可能产生的有害脱靶作用是必要的。
共有 33 名健康年轻男性(平均年龄 30 岁)参与了这项研究。所有患者均接受了促性腺激素释放激素(GnRH)拮抗剂皮下注射,其中 16 名患者随机分为第 1 次就诊时(V1)接受 300IU 重组 FSH(每周 3 次,300IE)治疗 5 周的治疗组,而 17 名患者作为对照组。分别在 V1、3 周后(V2)和 5 周后(V3)采血,此时研究结束。在 V2 时,所有患者均接受了 1000mg 十一酸睾酮肌内注射。使用 Mann-Whitney 检验对两组之间的生物和炎症标志物进行比较,并对多重检验进行了校正。
与对照组相比,接受 FSH 治疗的男性在 V2 时 SHBG 和白蛋白浓度更高(p=0.024 和 0.027),而丙氨酸氨基转移酶(p=0.026)和镁(p=0.028)水平更低V3。然而,经过 Bonferroni 校正后,没有任何结果具有统计学意义(p>0.0011)。
在 5 周的时间内,以标准治疗剂量给予年轻男性 FSH 对非生殖器官没有显著影响。因此,在其他方面健康的年轻男性中,FSH 治疗可以被认为是安全的,他们可以作为接受 FSH 治疗不育症的候选者。