Role of Nutritional Support in Idiopathic Male Infertility

NATURAmedicatrix

Status: Unknown

Conditions: Infertility, Male

Treatments: Dietary Supplement: Dietary Supplement with L-carnitine (FertilHom); Dietary Supplement: Control Dietary Supplement

Study type: Interventional

Funder types: Industry

Identifiers

NCT03588949

NATURAmedicatrix-FE-0001-M

Details and patient eligibility

About

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

Enrollment: 100 estimated patients

Sex: Male

Ages: 21 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups, including a placebo group

Active Dietary Supplement

Experimental group

Description:

Dietary Supplement with L-carnitine (FertilHom)

Treatment:

Dietary Supplement: Dietary Supplement with L-carnitine (FertilHom)

Control Dietary Supplement

Placebo Comparator group

Description:

Dietary Supplement with 50% RDA of beta-carotene

Treatment:

Dietary Supplement: Control Dietary Supplement