Trial | NCT03588949  Report issue

Title

Role of Nutritional Support in Idiopathic Male Infertility
Role of Nutritional Support in Idiopathic Male Infertility: a Randomized Dietary Study

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    100
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
Study Started
Oct 01
2018
Primary Completion
Apr 30
2020
Anticipated
Study Completion
Apr 30
2020
Anticipated
Last Update
Feb 26
2020

Dietary Supplement Dietary Supplement with L-carnitine (FertilHom)

1 stick of the TDS (vitamins, trace elements with carnitine) will be given 1 time daily in the evening before meals for 6 months or until pregnancy, depending whatever comes first

Dietary Supplement Control Dietary Supplement

1 stick of the TDSwill be given 1 time daily in the evening before meals for 6 months or until pregnancy, depending whatever comes first

Active Dietary Supplement Experimental

Dietary Supplement with L-carnitine (FertilHom)

Control Dietary Supplement Placebo Comparator

Dietary Supplement with 50% RDA of beta-carotene

Criteria 

Inclusion Criteria:

Informed consent form signed;
Age: 21-50;
Idiopathic male infertility;
Idiopathic oligo- and/or astheno- and/or teratozoospermia;
Stated availability throughout the study period and a mobile phone

Exclusion Criteria:

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;
Inflammatory bowel disease;
Known moderate to severe disease of any systems;
Known or suspected sexually transmitted diseases;
Alcohol or drug addiction of any couple counterpart as suspected by investigator;
Difficulty to comprehend study requirements as judged by investigator;
Use of any investigational product within the previous 3 months before entering the study;
Use of any drugs that stimulate or suppress spermatogenesis within previous 3 months
No Results Posted