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.

Tehran University of Medical Sciences90 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Idiopathic Oligoasthenoteratozoospermia Male Infertility

Interventions

Letrozole 2.5mgDRUG

Letrozole 2.5 mg tablet administered orally once daily for 3 months.

L-carnitineDRUG

L-Carnitine 1000 mg capsule administered orally once daily for 3 months.

Eligibility

Sex: MALEMin age: 20 YearsMax age: 45 Years

Medical Language ↔ Plain English

Inclusion Criteria: 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 Exclusion Criteria: 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)

Locations (1)

Shariati Hospital, Tehran University of Medical Sciences

Tehran, Iran

Outcomes

Primary Outcomes

Sperm concentration (×10⁶/mL) after 3 months of treatment

Change in sperm concentration from baseline to 3 months post-treatment

Time frame: 3 months

Progressive sperm motility (%) after 3 months of treatment

Change in progressive motility from baseline to 3 months post-treatment

Time frame: 3 months

Normal sperm morphology (%) after 3 months of treatment

Change in normal morphology from baseline to 3 months post-treatment

Time frame: 3 months

Secondary Outcomes

Serum testosterone and estradiol levels after 3 months of treatment

Change in hormonal profile from baseline to 3 months post-treatment

Time frame: 3 months

Sperm DNA fragmentation index (DFI) after 3 months of treatment

Change in DFI from baseline to 3 months post-treatment

Time frame: 3 months

Total antioxidant capacity (TAC) and reactive oxygen species (ROS) levels after 3 months of treatment

Time frame: 3 months

Mitochondrial membrane potential (MMP) after 3 months of treatment

Change in MMP from baseline to 3 months post-treatment

Time frame: 3 months

Fertilization rate and embryo quality after ICSI

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.