Medical Treatment Alone Versus Varicocelectomy Versus Varicocelectomy and Medical Treatment

What Was Tested

The trial (not phased) is built around L-Carnitine.

A varicocele is defined as an abnormal venous dilatation and/or tortuosity of the pampiniform plexus in the scrotum.

Varicocele has a negative impact on spermatogenesis, testicular volume, Standard semen parameters, and fertilization, implantation, and embryo outcomes.

It had three arms (groups): Group of l-carnitine and antioxidant (active comparator), Group of varicocelectomy (active comparator) and Group of Mixed Treatment(varicocelectomy then l-carnitine and antioxidant) (active comparator).

About 42 male patients suffering from teratozoospermia will take medical treatment (l-carnitine and antioxidant) once daily for 3 months.

About 42 male patients suffering from teratozoospermia will undergo subinguinal varicocelectomy.

About 42 male patients suffering from teratozoospermia will undergo subinguinal varicocelectomy then adjuvant treatment (l-carnitine and antioxidant) for 3 months.

The registry classes the interventions as drug.

More on the Plan

Varicocelectomy remains the first-line treatment option in infertile men with palpable varicocele and abnormal semen parameters, with the microsurgical subinguinal approach conveying the greatest success rate and fewest complications.

Physical examination of the scrotum remains the most commonly used technique to diagnose varicoceles.

Palpation of the scrotum is best performed in a relaxed patient in standing position, in a warm room and carried out by a well-trained physician.

Who Took Part

Enrollment: 126 planned participants were the target.

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.

Examples of who could join: Sub-fertile men with clinically palpable varicoceles ( unilateral or bilateral ). Men with teratozoospermia.

The full record lists 2 inclusion and 4 exclusion criteria; among the exclusions: recurrent varicoceles; hypersensitivity to the drugs; female factor of infertility.

How the Study Was Run

Design: randomized, parallel-group and open-label.

Random assignment meant chance, not the researchers, decided who got L-Carnitine and who got the comparison, which limits bias.

The L-Carnitine group and the comparison group ran side by side rather than switching.

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.

It started in 2024-09-01 with completion listed for 2025-08-20.

It ran at 1 site in Egypt.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Number of participants with Treatment of Teratozoospermia (time frame: 3 months).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of L-Carnitine in 126 people.

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

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