Role of Nutritional Support in Idiopathic Male Infertility

Study Overview
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Brief Summary
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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

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

Conditions
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Infertility, Male

Intervention / Treatment
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* Dietary Supplement: Dietary Supplement with L-carnitine (FertilHom)
* Dietary Supplement: Control Dietary Supplement


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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