Male Fertility Male Factor Treatment

Pharmacogenetics of follicle-stimulating hormone action in the male

Graziani A, Grande G, Scafa R, Selice R, Garolla A, Rocca MS, Vinanzi C, Ferlin A

Published May 2026 Andrology
DOI 10.1111/andr.70053 PMID 40304702 PMC PMC13040318

RRM Academy Synopsis

Gene variants cannot yet reliably predict FSH response in men

Gene variants cannot yet predict which infertile men will respond to FSH therapy, a 2026 review of FSHB and FSHR studies in male infertility found. The authors say gene testing should stay in research for now.

Key Findings

  • Evidence so far indicates the T allele of the FSHB c.-211G > T variant has half the promoter activity of the wild-type G allele.
  • One cross-sectional study from the authors' group found that infertile men with two T copies (TT) showed a larger rise in semen parameters after FSH than GT or GG men.
  • A study of about 40 men with male factor infertility found response to FSH independent of genotype. A study of 1075 azoospermic men linked TT to a lower likelihood of sperm retrieval.
  • A pilot study of 70 oligozoospermic men found that Ser allele carriers of FSHR Asn680Ser gained on semen measures after FSH. Another study found lower sperm DNA fragmentation only in N homozygotes.
  • Citing combined results from earlier studies, the review puts the number needed to treat with FSH at 10 to 18 men per pregnancy in unexplained male infertility.

Interpretation

This is a narrative review of FSHB and FSHR gene studies in men treated with FSH for male infertility. The authors say the evidence does not yet show whether gene testing should guide FSH treatment. Current guidelines limit this testing to research. The findings support larger studies of this approach.

RRM Context

The review reports unexplained cases in up to 30%-50% of male infertility. Care often stops at a semen test. Restorative reproductive medicine treats an unexplained result as undiagnosed and looks for the cause in both partners. The authors call infertility a couple's problem, with both partners tested together.

Abstract

Male factor infertility (MFI) is involved in half of the cases of couple infertility. The follicle-stimulating hormone (FSH) therapy is considered efficient to improve semen parameters and pregnancy rate in patients with idiopathic MFI, following the lesson learned from hypogonadotropic hypogonadism. However, while in patients with hypogonadotropic hypogonadism FSH therapy, in combination with human chorionic gonadotropin (hCG), is a well-established treatment, in patients with MFI the effects of the FSH therapy are variable and unpredictable. The FSH therapy in MFI should be a personalized treatment, tailored on the characteristics of the male patient and the couple. The pivotal aspect is the accurate identification of patients who might benefit from such treatment (responders) from those who might not (nonresponders). To date, selection of patients to be treated is based on history, physical examination, semen analysis, and hormonal assessment. However, these parameters cannot adequately identify a priori responder patients. Furthermore, tailored management should include pharmacological adaptation (dosage and duration of the therapy), as happens during ovarian hyperstimulation in assisted reproductive technologies. In a fully personalized therapy, pharmacogenetic factors must be considered. In this paper, we describe the evidence dealing with the pharmacogenetics of the FSH therapy in MFI, presenting the physiological and physiopathological basis and the pharmacogenetics studies dealing with effects of polymorphisms in the beta-subunit of FSH (FSHB) and the FSH receptor (FSHR) gene. According to the evidence so far available, genetic evaluation of FSHB and FSHR is recommended only for research purposes, since the data are not conclusive and even contrasting. Furthermore, the evidence so far is derived from quite small studies with different endpoints considered and relatively few cases. Better studies that consider the combined effect of several FSHB and FSHR gene polymorphisms, together with clinical, biochemical, seminal and testicular cytology, are necessary to develop an algorithm that might predict the response to the FSH treatment.

Topics

By this author

Related research

Male Fertility › Male Factor Treatment › Medical Management · Therapeutics › Hormonal Agents › Gonadotropins · Genetics and Immunology › Reproductive Genetics › Single Gene Conditions
Andrea Graziani, Giuseppe Grande, Raffele Scafa, Riccardo Selice, Andrea Garolla, Maria Santa Rocca, Cinzia Vinanzi, Alberto Ferlin
A Graziani, G Grande, R Scafa, R Selice, A Garolla, M Rocca, C Vinanzi, A Ferlin
PMID 40304702 40304702 DOI 10.1111/andr.70053 10.1111/andr.70053 Graziani et al. 2026, Graziani 2026