Skip to main content
OpenTrials
Completed

NCT Number: NCT04177667

Body Mass Index and Age Correlate With Antioxidant Supplementation Effects on Sperm Quality

Spermatozoa are vulnerable to lack of energy and oxidative stress as a result of elevated levels of reactive oxygen species. Therefore, it is essential that appropriate nutrients are available during maturation.

This randomized, double-blind, placebo-controlled trial investigated the effect of 6 months supplementation with carnitines and other micronutrients on sperm quality in 104 subjects with oligo- and/or astheno- and/or teratozoospermia with or without varicocele. Semen analyses were done at the beginning and end of the treatment. In addition to main analyses, post-hoc analyses for age and body mass index (BMI) were carried out. Results were interpreted by dividing the population into two age and BMI classes.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Male Infertility Genital Diseases Genital Diseases, Male Infertility Infertility, Male Male Urogenital Diseases Urogenital Diseases

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • men with oligo- and/or astheno- and/or terato-zoospermia
  • with or without varicocele
  • men aged between 18 and 50 years
  • men from couples with history of difficulty conceiving for more than 12 months

Exclusion criteria

  • subjects with known hypersensitivity to any of the treatment compound
  • history of undescended testes or cancer
  • endocrine disorders
  • history of post-pubertal mumps
  • genitourinary surgery
  • obstructive azoospermia or obstructive pathology of the urogenital system
  • autoimmune disease
  • cystic fibrosis
  • history of taking any therapy affecting fertility within last 3 months
  • excessive consumption of alcohol or regular use of illicit or "recreational" drugs
  • positive serology for HIV
  • subjects following any special diet
  • any condition which in the opinion of the investigator might put the subject at risk by participation in this study and subjects involved in any other clinical trials

Treatment and study plan

Proxeed

Dietary Supplement

Treatment with dietary supplement for male infertility for Proxeed Arm

Placebo

Other

Treatment with placebo for Placebo Arm

Primary outcomes

  1. Evaluation of sperm concentration (millions/ml) on spermogram of infertile men

    Time frame: 6 months

    Efficacy of the therapy on sperm concentration (millions/ml) of subject affected by male infertility with or without varicocele. Parameters have been compared in accordance with body mass index and age.

  2. Evaluation of sperm motility (%) on spermogram of infertile men

    Time frame: 6 months

    Efficacy of the therapy on sperm motility (%) of subject affected by male infertility with or without varicocele. Parameters have been compared in accordance with body mass index and age.

  3. Evaluation of sperm normal morphology (%) on spermogram of infertile men

    Time frame: 6 months

    Efficacy of the therapy on sperm normal morphology (%) of subject affected by male infertility with or without varicocele. Parameters have been compared in accordance with body mass index and age.

Secondary outcomes

  1. Evaluation of pregnancy rate (number)

    Time frame: 6 months

    Pregnancy rate is the number of pregnancies including live births, still births and therapeutic abortions

Sponsors and collaborators

Lead sponsor

University of Roma La Sapienza

Other

Registry information

Official study title

Body Mass Index and Age Correlate With Antioxidant Supplementation Effects on Sperm Quality: Post-hoc Analyses From a Double-blind Placebo-controlled Trial

Important dates

Study start
2014
Primary completion
2015
Study completion
2017
First posted
Nov 26, 2019
Registry last updated
Nov 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.