Role of Nutritional Support in Idiopathic Male Infertility

Not Applicable

• Conditions: Infertility, Male
• Interventions: Dietary Supplement: Dietary Supplement with L-carnitine (FertilHom); Dietary Supplement: Control Dietary Supplement

• Registration Number: NCT03588949
• Lead Sponsor: NATURAmedicatrix Sàrl

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-06-26
• Study First Submitted QC: 2018-07-15
• Study First Posted: 2018-07-17
• Study Start: 2018-10-01
• Status Verified: 2019-08
• Last Update Submitted: 2020-02-25
• Last Update Posted: 2020-02-26
• Primary Completion: 2020-04-30
• Study Completion: 2020-04-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active Dietary Supplement	Dietary Supplement with L-carnitine (FertilHom)	Dietary Supplement with L-carnitine (FertilHom)
Control Dietary Supplement	Control Dietary Supplement	Dietary Supplement with 50% RDA of beta-carotene

Primary Outcome Measures

Name	Time	Method
Rate of normalization of spermogram	4 months	None deviation found in spermogram

Trial Locations

Locations (1)

MedianaStatistics; 🇺🇦 Lviv, Ukraine