Role of Nutritional Support in Idiopathic Male Infertility

What Was Tested

This registered not phased trial tested L-Carnitine.

Approximately 100 males with idiopathic infertility and oligo- and/or astheno- and/or and/or teratozoospermia and fertile woman will take a Test dietary supplement (TDS), containing carnitine, vitamins and trace elements (active group) or carotene (control group) for 6 months (50 subjects in active and control groups).

Before intake, and 2 and 4 months after the commencement of TDS, all males will have spermogram.

After 6-month use of the TDS and during the 12th month of the study, couples will be screened for conception, pregnancy, and a newborn.

It had two arms (groups): Active Dietary Supplement (experimental) and Control Dietary Supplement (placebo comparator).

Dietary Supplement with L-carnitine (FertilHom).

The registry classes the interventions as dietary supplement.

Who Took Part

The registry lists 100 planned participants were the target.

It was open to men only aged from 21 years up to 50 years.

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

Examples of who could join: Informed consent form signed;. Idiopathic male infertility;. Idiopathic oligo- and/or astheno- and/or teratozoospermia;. Stated availability throughout the study period and a mobile phone.

The full record lists 5 inclusion and 10 exclusion criteria; among the exclusions: allergy to any component of the dietary supplement;; known genetic, anatomical, endocrine, inflammatory or traumatic testicular cause of male infertility;; known genetic, anatomical, endocrine, inflammatory or traumatic testicular cause of female infertility;.

How the Study Was Run

The set-up was 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.

As a double-blind L-Carnitine study, the assignments were hidden from both participants and investigators until the end.

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

It started in 2018-10-01 with completion listed for 2020-04-30.

It ran at 1 site in Ukraine.

Its stated primary purpose is other.

What Was Measured

The main thing measured (primary outcome): Rate of normalization of spermogram (time frame: 4 months).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of L-Carnitine in 100 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.