Use of Biosimilar Follicle-Stimulating Hormone in Asthenozoospermic Infertile Patients: A Multicentric Study.

Maurizio De Rocco Ponce,Andrea Di Nisio,Alessandro Dal Lago,Carlo Foresta,Sandro La Vignera,Rocco Rago,Andrea Garolla,Giancarlo Balercia,Aldo Eugenio Calogero,Ilaria Cosci

doi:10.3390/jcm9051478

Abstract

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.

Highlights

The gonadotropin follicle-stimulating hormone (FSH) is a glycoprotein polypeptide synthesized and secreted by the gonadotropic cells of the anterior pituitary gland upon the pulsatile stimulus of the gonadotropin-releasing hormone (GnRH) produced by the hypothalamus [1]
Exogenous FSH administration significantly increases the number of spermatogonia in monkeys, suggesting that spermatogenesis can be overstimulated above the physiological rate [20,21]
Ninety-seven infertile asthenozoospermic patients and 50 control patients were recruited from the four participant centres

Summary

Introduction

The gonadotropin follicle-stimulating hormone (FSH) is a glycoprotein polypeptide synthesized and secreted by the gonadotropic cells of the anterior pituitary gland upon the pulsatile stimulus of the gonadotropin-releasing hormone (GnRH) produced by the hypothalamus [1] After secretion, it reaches the gonads where, in the male, FSH has an important role in testicular development and spermatogenesis, as demonstrated by several studies in both animal models and humans [2,3,4,5,6,7]. Some studies have shown an improvement in sperm structure and DNA fragmentation after FSH therapy, and promising results have been found in patients with high levels of DNA fragmentation index (DFI) [30,31] These findings may explain the improved results in oocyte fertilization and pregnancy rate sometimes obtained despite the absence of any improvement of classical seminal parameters in couples undergoing artificial reproductive therapy (ART) [32]. In infertile couples with idiopathic male factor, FSH (either human or recombinant) seems to be effective in increasing spontaneous pregnancy rates [33]

Results

Discussion

Conclusion