Role of Nutritional Support in Idiopathic Male Infertility

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

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 Overview

• Status: Unknown
• Conditions: Infertility, Male
• Intervention / Treatment: Dietary supplement: Dietary Supplement with L-carnitine (FertilHom); Dietary supplement: Control Dietary Supplement

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sergiy V Gerasymov, MD,PhD; Phone Number: +380679375951; Email: mediana.statistics@gmail.com

Study Locations

• Ukraine
  • Lviv, Ukraine, 79012
    • Recruiting
    • MedianaStatistics
    • Contact: Sergiy V Gerasymov, MD,PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Allergy to any component of the dietary supplement;
2. Known genetic, anatomical, endocrine, inflammatory or traumatic testicular cause of male infertility;
3. Known genetic, anatomical, endocrine, inflammatory or traumatic testicular cause of female infertility;
4. Inflammatory bowel disease;
5. Known moderate to severe disease of any systems;
6. Known or suspected sexually transmitted diseases;
7. Alcohol or drug addiction of any couple counterpart as suspected by investigator;
8. Difficulty to comprehend study requirements as judged by investigator;
9. Use of any investigational product within the previous 3 months before entering the study;
10. Use of any drugs that stimulate or suppress spermatogenesis within previous 3 months

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active Dietary Supplement; Dietary Supplement with L-carnitine (FertilHom)	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
Placebo Comparator: Control Dietary Supplement; Dietary Supplement with 50% RDA of beta-carotene	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of normalization of spermogram	None deviation found in spermogram	4 months

Collaborators and Investigators

• Sponsor: NATURAmedicatrix Sàrl
• Investigators: Study Director: Marco Pietteur, NATURAmedicatrix Sarl

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2018
• Primary Completion (Anticipated): April 30, 2020
• Study Completion (Anticipated): April 30, 2020

Study Registration Dates

• First Submitted: June 26, 2018
• First Submitted That Met QC Criteria: July 15, 2018
• First Posted (Actual): July 17, 2018

Study Record Updates

• Last Update Posted (Actual): February 26, 2020
• Last Update Submitted That Met QC Criteria: February 25, 2020
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infertility; Infertility, Male
• Other Study ID Numbers: NATURAmedicatrix-FE-0001-M

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No