Comparison of Acetyl- L- Carnitine& Folic Acid Versus Coenzyme Q10& Folic Acid on Semen& Hormonal Parameters& Semen Oxidative Status in Patients of Primary Infertility. A Double Blind Randomized Clinical Trial

What Was Tested

In this phase 2 trial, researchers set out to test L-Carnitine.

The investigators aim is to conduct a double blind randomized clinical trial, to study the effects of Acetyl-L-Carnitine and folic acid versus Coenzyme Q10 and folic acid on Semen and hormonal parameters and semen oxidative stress in patients of Primary infertility.

Males diagnosed with Primary Infertility are recruited in the study after fulfilling the inclusion nd exclusion criteria.

The investigators propose that Primary infertile men may have altered seminal oxidative status \& the combinational therapy may achieve favorable seminal , hormonal\& antioxidant levels in men having Primary infertility.

It had two arms (groups): Acetyl-L-Carnitine group (experimental) and Control group (experimental).

The registry classes the interventions as drug.

More on the Plan

Male infertility is mainly caused by oxidative stress.

O2- (superoxide anion), OH- (hydroxyl ions), H2O2 (hydrogen peroxide), nitric oxide \& ROO- (peroxyl) radicals are all oxygen derived highly reactive oxygen species with a free unpaired electron in their outer orbit making them short lived, highly reactive \& unstable.

They are produced by the sperms \& their normal level help in the sperm maturation, motility, capacitation \& facilitation of fertilization.

Sperms are at risk of the damage caused by overproduction of these ions.

Who Took Part

86 actual participants took part.

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

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

Examples of who could join: Treatment naïve primary male infertile patients with Oligospermia, Asthenozoospermia , Teratozoospermia \& Necrozoospermia. Aged between 20 - 45 years. Married for more than a year with regular intercourse minimum 3/week. Normal female partner with normal menstrual cycle.

The full record lists 4 inclusion and 5 exclusion criteria; among the exclusions: azoospermic patients; patients with varicocoele; erectile dysfunction.

How the Study Was Run

Design: randomized, parallel-group and triple-blind.

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

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

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

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

It started in 2022-08-06 with completion listed for 2022-11-28.

It ran at 1 site in Pakistan.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): change in semen analysis before& after the administration of antioxidants& folic acid (time frame: it will be done at the start of the trial and then after 3 months). change in seminal oxidative status before& after the administration of antioxidants& folic acid (time frame: it will be done at the start of the trial and then after 3 months). change in serum testosterone in nanograms/dl before& after the administration of antioxidants& folic acid (time frame: it will be done at the start of the trial and then after 3 months).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of L-Carnitine in 86 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.