Impact of tdrd9 Gene Mutations in the Therapeutic Response to L-carnitine in Oligoasthenozoospermic Men

What Was Tested

The trial (phase 3) is built around L-Carnitine.

For the majority of cases however the etiology remains unknown, and is termed idiopathic infertility.

It had 1 arm (groups): Tdrd9 positive and negative (experimental).

L-carnitine.

The registry classes the interventions as drug.

More on the Plan

Despite advances in diagnostic techniques, the etiology of male infertility remains unidentified in a substantial proportion of patients and is therefore classified as idiopathic infertility.

Among the various causes of male infertility, abnormalities in sperm production and function constitute the most frequent underlying pathology.

Azoospermia, defined as the complete absence of spermatozoa in the ejaculate, is one of the most severe manifestations of male infertility.

Azoospermia may be obstructive or non-obstructive, with the latter reflecting intrinsic defects in spermatogenesis and frequently having a genetic basis.

Who Took Part

Enrollment: 50 actual participants took part.

It was open to men only aged from 20 years up to 50 years.

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

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 2026-01-01 with completion listed for 2026-06.

It ran at 1 site in Egypt.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change in total motile sperm count (TMSC) from baseline to 3 months (time frame: Baseline to 3 months).

It also tracked 4 secondary outcomes, for example Change in sperm concentration from baseline to 3 months, Change in normal sperm morphology from baseline to 3 months, Change in semen volume from baseline to 3 months and Change in serum follicle-stimulating hormone (FSH) levels from baseline to 3 months.

What This Means in Plain Language

Put simply, this is a phase 3 trial of L-Carnitine in 50 people.

Its status is active not recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

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