Role of Nutritional Support in Idiopathic Male Infertility

Infertility, Male Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03588949
• Other study ID #: NATURAmedicatrix-FE-0001-M
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2018
• Est. completion date: April 30, 2020

Study information

• Verified date: August 2019
• Source: NATURAmedicatrix Sàrl
• Contact: Sergiy V Gerasymov, MD,PhD
• Phone: +380679375951
• Email: mediana.statistics[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: April 30, 2020
• Est. primary completion date: April 30, 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 21 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility
• Infertility, Male

Intervention

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
• 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

Locations

Country	Name	City	State
Ukraine	MedianaStatistics	Lviv

Sponsors (1)

Lead Sponsor	Collaborator
NATURAmedicatrix Sàrl

Country where clinical trial is conducted

Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of normalization of spermogram	None deviation found in spermogram	4 months