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.

What Was Tested

This registered phase 2, phase 3 trial tested L-Carnitine.

It had three arms (groups): Letrozole (experimental), L-Carnitine Monotherapy (experimental) and Combination Therapy (experimental).

The registry classes the interventions as drug.

More on the Plan

Sperm parameters, hormonal profiles, oxidative stress biomarkers, mitochondrial function, and ICSI outcomes were assessed before and after treatment.

Who Took Part

90 actual participants took part.

It was open to men only aged from 20 years up to 45 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-blind study.

The participants were allocated by chance, so the L-Carnitine group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Blinding on both sides kept the participants and researchers unaware of who received L-Carnitine.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2023-12-01 with completion listed for 2026-02-28.

It ran at 1 site in Iran.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Sperm concentration (×10⁶/mL) after 3 months of treatment (time frame: 3 months). Progressive sperm motility (%) after 3 months of treatment (time frame: 3 months). Normal sperm morphology (%) after 3 months of treatment (time frame: 3 months).

It also tracked 5 secondary outcomes, for example Serum testosterone and estradiol levels after 3 months of treatment, Sperm DNA fragmentation index (DFI) after 3 months of treatment, Total antioxidant capacity (TAC) and reactive oxygen species (ROS) levels after 3 months of treatment, Mitochondrial membrane potential (MMP) after 3 months of treatment and Fertilization rate and embryo quality after ICSI.

What This Means in Plain Language

Put simply, this is a phase 2, phase 3, randomized trial of L-Carnitine in 90 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the L-Carnitine compound page, all human trials.