Ullur Pallavi, Kubera N S, Manikandan Soliappappan, Nanda Nivedita, Venkatraman Sujatha, Ram Anusuya
Department of Obstetrics and Gynaecology, AIIMS, Bibinagar, Telangana.
Department of Obstetrics and Gynaecology, JIPMER, Puducherry, India.
J Hum Reprod Sci. 2025 Jan-Mar;18(1):2-8. doi: 10.4103/jhrs.jhrs_160_24. Epub 2025 Mar 29.
Currently lack of consensus regarding the medical treatment of men with Oligoasthenoteratozoospermia (OATS). Letrozole is an aromatase inhibitor and may improve semen quality by stimulating hormone synthesis and spermatogenesis. There is lack of evidence on the efficacy and safety of letrozole as therapy for male infertility.
To study the efficacy of letrozole in improving semen parameters, hormonal profile of participants with moderate-to-severe OATS and its side effects.
Randomised double-blinded placebo-controlled trials conducted in a tertiary care centre conducted between August 2021 and July 2023. Men with abnormal semen analysis reports between the age group of 21 and 45 years with moderate-to-severe OATS visiting the male infertility clinic were enrolled.
Fifty-four men were randomised into two groups. Twenty-eight men in A (intervention group) received letrozole, and 24 men in Group B (control group) received a placebo after written informed consent. After 3 months, semen analysis and hormonal parameters were studied.
Data analysis was performed using SPSS version 19 (IBM). Associations between categorical variables in two groups were analysed using the Chi-square test or Fisher's exact test. Continuous variables were compared using the Mann-Whitney test, and independent Students' -test and pre- and post-treatment comparisons of continuous variables were assessed using a paired -test or Wilcoxon signed-rank test.
Total sperm count increased by 4.4 (2.8, 8.8) million per ejaculate, sperm concentration by 3.2 (1, 4.4) million/mL and progressive motility by 5.8 ± 7.3% compared to the placebo group, which was statistically significant ( = 0.001). The use of letrozole had minor side effects like headache and nausea. Letrozole use in men with OATS showed a significant improvement in follicle-stimulating hormone by 6.8 ± 5.5 mIU/mL, luteinising hormone by 6.3 ± 3.3 IU/L, testosterone by 193.3 ± 130 ng/dL, with value of 0.001 and significant fall in oestradiol by 17.6 ± 7.9 pg/mL overall improving T/E ratio by 18.4 ± 8.8.
Letrozole use may result in improving semen parameters in men with moderate-to-severe OATS. However, these findings need to be validated in larger trials.
目前对于少弱畸精子症（OATS）男性的医学治疗缺乏共识。来曲唑是一种芳香化酶抑制剂，可能通过刺激激素合成和精子发生来改善精液质量。缺乏关于来曲唑治疗男性不育症的疗效和安全性的证据。
研究来曲唑改善中度至重度OATS患者精液参数、激素水平及其副作用的疗效。
2021年8月至2023年7月在一家三级医疗中心进行的随机双盲安慰剂对照试验。纳入年龄在21至45岁之间、精液分析报告异常且患有中度至重度OATS并前往男性不育门诊就诊的男性。
54名男性被随机分为两组。A组（干预组）28名男性接受来曲唑治疗，B组（对照组）24名男性在签署书面知情同意书后接受安慰剂治疗。3个月后，研究精液分析和激素参数。
使用SPSS 19版（IBM公司）进行数据分析。两组分类变量之间的关联使用卡方检验或费舍尔精确检验进行分析。连续变量使用曼-惠特尼检验进行比较，连续变量的独立样本t检验以及治疗前后比较使用配对t检验或威尔科克森符号秩检验进行评估。
与安慰剂组相比，每次射精的总精子数增加了440万（280万，880万），精子浓度增加了320万/mL，前向运动率增加了5.8±7.3%，差异具有统计学意义（P = 0.001）。来曲唑的使用有轻微副作用，如头痛和恶心。在患有OATS的男性中使用来曲唑显示促卵泡激素显著改善6.8±5.5 mIU/mL，促黄体生成素改善6.3±3.3 IU/L，睾酮改善193.3±130 ng/dL，P值为0.001，雌二醇显著下降17.6±7.9 pg/mL，总体上T/E比值提高了18.4±8.8。
使用来曲唑可能会改善中度至重度OATS男性的精液参数。然而，这些发现需要在更大规模的试验中得到验证。
