De Rocco Ponce Maurizio, Foresta Carlo, Rago Rocco, Dal Lago Alessandro, Balercia Giancarlo, Calogero Aldo Eugenio, La Vignera Sandro, Cosci Ilaria, Di Nisio Andrea, Garolla Andrea
UOC Andrologia e Medicina della Riproduzione, Azienda Ospedaliera Università di Padova, Dipartimento di Medicina, 35126 Padova, Italy.
Unità di Fisiopatologia della Riproduzione e Andrologia, Ospedale Sandro Pertini, 00157 Roma, Italy.
J Clin Med. 2020 May 14;9(5):1478. doi: 10.3390/jcm9051478.
There is increasing data in favour of follicle-stimulating hormone (FSH) therapy in patients with oligo-asthenozoospermia and normal-range gonadotropins in order to increase sperm count and above all sperm motility. Some studies showed an improvement in DNA fragmentation and spontaneous pregnancy. Recently, biosimilar FSH has been marketed with the same indications. We performed a retrospective multicentric case-control study involving 147 asthenozoospermic patients between 18 and 45 years of age. A total of 97 patients were treated with biosimilar FSH 150 UI three times a week for 3 months, while 50 control subjects received no treatment. Patients were evaluated at baseline and after 3 months with semen analysis including DNA fragmentation, testicular colour Doppler ultrasound, and blood tests. Spontaneous pregnancies were recorded during a further follow-up period of 6 months. Treated patients showed after treatment a statistically significant increase in sperm concentration, total sperm count, and total motile sperm, as well as improved progressive motility and non-progressive motility. DNA fragmentation showed a significant reduction. Conversely, in the control group, no significant change was found. Pregnancy rate was significantly higher in treated patients. These data suggest comparable efficacy of biosimilar FSH in the treatment of male infertility; however, larger studies are needed to confirm our results.
越来越多的数据支持在少弱精子症且促性腺激素水平在正常范围内的患者中使用促卵泡生成素（FSH）治疗，以增加精子数量，尤其是提高精子活力。一些研究表明，这种治疗可改善精子DNA碎片率并提高自然受孕率。最近，生物类似物FSH已上市，适应证相同。我们进行了一项回顾性多中心病例对照研究，纳入了147例年龄在18至45岁之间的弱精子症患者。其中97例患者每周三次接受150 UI生物类似物FSH治疗，持续3个月，而50例对照受试者未接受治疗。在基线和3个月后对患者进行评估，评估内容包括精液分析（包括DNA碎片率）、睾丸彩色多普勒超声检查和血液检查。在接下来6个月的随访期内记录自然受孕情况。治疗后的患者精子浓度、总精子数和总活动精子数均有统计学意义的显著增加，同时精子前向运动能力和非前向运动能力也有所改善。DNA碎片率显著降低。相反，对照组未发现显著变化。治疗组患者的妊娠率显著更高。这些数据表明生物类似物FSH在治疗男性不育症方面具有相当的疗效；然而，需要更大规模的研究来证实我们的结果。
