跳至主要内容
临床试验/NCT07669402
NCT07669402已完成2 期

Comparative Evaluation of the Efficacy of Letrozole, L-Carnitine, and Their Combination on Sperm Quality, Oxidative Stress, and ART Outcomes in Men With Idiopathic Oligoasthenoteratozoospermia: A Three-Arm Randomized Clinical Trial.

Tehran University of Medical Sciences1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2023年12月1日最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
90
试验地点
1

研究概览

简要总结

This is a randomized clinical trial evaluating the efficacy of Letrozole, L-Carnitine, and their combination on sperm quality, oxidative stress, and ART outcomes in men with idiopathic oligoasthenoteratozoospermia.

详细描述

This three-arm randomized controlled trial included 90 men with idiopathic oligoasthenoteratozoospermia (iOAT) who were assigned to receive Letrozole (2.5 mg/day), L-Carnitine (1000 mg/day), or combination therapy for 3 months. Sperm parameters, hormonal profiles, oxidative stress biomarkers, mitochondrial function, and ICSI outcomes were assessed before and after treatment.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

盲法说明

All participants, care providers, investigators, and outcome assessors were blinded to group allocation.

入排标准

年龄范围
20 Years 至 45 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • Diagnosis of idiopathic oligoasthenoteratozoospermia (iOAT) per WHO 2021 criteria
  • Age 20 to 45 years
  • BMI between 18 and 30 kg/m²
  • No prior hormonal therapy or antioxidant supplements within the last 3 months

排除标准

  • Varicocele, cryptorchidism, or genital tract infection
  • Hormonal disorders (hypogonadism, hyperprolactinemia, thyroid dysfunction)
  • Smoking, alcohol use, or drug abuse
  • Use of testosterone or anabolic steroids within the last 6 months
  • Female partner with severe infertility factors (age ≥40, tubal blockage, severe endometriosis)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验