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Background <p>Empirical medical treatments (EMT) including exogenous hormone therapy are frequently used for management of idiopathic infertility. The causes, treatment methods, accessibility, and socioeconomic factors of male infertility differ considerably between high-income countries (HIC) and low- and middle-income countries (LMIC). Hence it is essential to study infertility treatment practices in different clinical settings. This narrative review aims to provide an overview of the use of hormonal treatments such as selective estrogen receptor modulators (SERM), aromatase inhibitors (AI), and recombinant FSH (rFSH) for the management of idiopathic infertility reported in clinical trials in HIC and LMIC.</p> Main body <p>In total, 59 clinical trials (HIC − 40, LMIC-18, multicentric-1) were included in this review, where it evaluates the effectiveness of EMT for the management of idiopathic infertility. About 23 RCTs were conducted on injectable hormone therapy (HIC-21; LMIC-2) and 36 RCTs were on oral hormone therapy (HIC-19; LMIC-16; multicenteric-1). Overall, an improvement in sperm concentration was reported in 28 studies using oral therapy and in 14 studies using injectable treatment. Improvement on sperm motility was reported in 22 studies using oral therapy and 10 studies using injectables. One-third of studies showed an improvement in hormonal parameters using oral (<i>n</i> = 24) and injectable medications (<i>n</i> = 11). Additionally, in LMIC, SERM and AI have been shown to be more effective than injectables in treating idiopathic male infertility.</p> Conclusion <p>Results from the RCTs, pattern of reported outcomes varied between HIC and LMIC following the use of oral and injectables hormonal EMT. This could be probably due to variations in sample size, ethnicity, selection criteria, dosage, duration of treatment, small number of studies, and outcomes measures. Nonetheless, well designed RCTs with larger sample size across different populations in HIC and LMIC are required to conclusively determine the best outcomes.</p>

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Hormonal Therapy for the Management of Idiopathic Male Infertility: A Narrative Review of Randomized Controlled Trials Conducted in High-Income and Lower-Middle-Income Countries

  • 期刊论文

  • 发表日期：

    2026年4月10日

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  • Shagufta Afzal Khan,
  • Purva Mangesh Kadu,
  • Periyasamy Kuppusamy

摘要

Background

Empirical medical treatments (EMT) including exogenous hormone therapy are frequently used for management of idiopathic infertility. The causes, treatment methods, accessibility, and socioeconomic factors of male infertility differ considerably between high-income countries (HIC) and low- and middle-income countries (LMIC). Hence it is essential to study infertility treatment practices in different clinical settings. This narrative review aims to provide an overview of the use of hormonal treatments such as selective estrogen receptor modulators (SERM), aromatase inhibitors (AI), and recombinant FSH (rFSH) for the management of idiopathic infertility reported in clinical trials in HIC and LMIC.

Main body

In total, 59 clinical trials (HIC − 40, LMIC-18, multicentric-1) were included in this review, where it evaluates the effectiveness of EMT for the management of idiopathic infertility. About 23 RCTs were conducted on injectable hormone therapy (HIC-21; LMIC-2) and 36 RCTs were on oral hormone therapy (HIC-19; LMIC-16; multicenteric-1). Overall, an improvement in sperm concentration was reported in 28 studies using oral therapy and in 14 studies using injectable treatment. Improvement on sperm motility was reported in 22 studies using oral therapy and 10 studies using injectables. One-third of studies showed an improvement in hormonal parameters using oral (n = 24) and injectable medications (n = 11). Additionally, in LMIC, SERM and AI have been shown to be more effective than injectables in treating idiopathic male infertility.

Conclusion

Results from the RCTs, pattern of reported outcomes varied between HIC and LMIC following the use of oral and injectables hormonal EMT. This could be probably due to variations in sample size, ethnicity, selection criteria, dosage, duration of treatment, small number of studies, and outcomes measures. Nonetheless, well designed RCTs with larger sample size across different populations in HIC and LMIC are required to conclusively determine the best outcomes.