Sperm DNA Damage in β-thalassemia Major: Is There a Role for Antioxidants?

What Was Tested

This registered phase 1, phase 2 trial tested L-Carnitine for male fertility and sperm.

Accumulation of iron in patients with beta thalassemia major causes free radical formation which leads to damage of biological membranes.

Sperm DNA damage may result from these generated antioxidants.

The researchers aimed at investigating the current DNA damage in the sperms of adult patients with beta thalassemia major and the effect generated by giving antioxidant treatment for 6 months.

It had 1 arm (groups): Antioxidant treatment (other).

The registry classes the interventions as drug.

Who Took Part

The registry lists 30 planned participants were the target.

It was open to men only aged from 16 years with no upper age limit.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Pubertal patients with beta thalassemia major.

The full record lists 1 inclusion and 1 exclusion criteria; among the exclusions: associated endcrinopathy.

How the Study Was Run

It was run as a single-group and open-label study.

Everyone knew when L-Carnitine was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2015-02 with completion listed for 2017-12.

It ran at 3 sites in Egypt (3).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: DNA fragmentation index (time frame: 6 months).

What This Means in Plain Language

Put simply, this is a phase 1, phase 2 trial of L-Carnitine in 30 people with male fertility and sperm.

Its size is small, so on its own it can only give an early look.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the L-Carnitine compound page, Male fertility and sperm research.