Role of Nutritional Support in Idiopathic Male Infertility

NCT ID: NCT03588949

Last Updated: 2020-02-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-01
• Study Completion Date: 2020-04-30

Brief 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

Conditions

Infertility, Male

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

Active Dietary Supplement

Dietary Supplement with L-carnitine (FertilHom)

Group Type: EXPERIMENTAL

Dietary Supplement with L-carnitine (FertilHom)

Intervention Type: DIETARY_SUPPLEMENT

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

Dietary Supplement with 50% RDA of beta-carotene

Group Type: PLACEBO_COMPARATOR

Control Dietary Supplement

Intervention Type: 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

Interventions

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

Intervention Type: 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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

NATURAmedicatrix Sàrl

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marco Pietteur

Role: STUDY_DIRECTOR

NATURAmedicatrix Sarl

Locations

MedianaStatistics

Lviv, , Ukraine

Site Status: RECRUITING

Countries

Ukraine

Central Contacts

Sergiy V Gerasymov, MD,PhD

Role: CONTACT

mediana.statistics@gmail.com

+380679375951

Facility Contacts

Sergiy V Gerasymov, MD,PhD

Role: primary

Other Identifiers

NATURAmedicatrix-FE-0001-M

Identifier Type: -

Identifier Source: org_study_id