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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Dietary Supplement | Experimental | Dietary Supplement with L-carnitine (FertilHom) |
|
| Control Dietary Supplement | Placebo Comparator | Dietary Supplement with 50% RDA of beta-carotene |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dietary Supplement with L-carnitine (FertilHom) | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of normalization of spermogram | None deviation found in spermogram | 4 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sergiy V Gerasymov, MD,PhD | Contact | +380679375951 | mediana.statistics@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Marco Pietteur | NATURAmedicatrix Sarl | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MedianaStatistics | Recruiting | Lviv | 79012 | Ukraine |
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| ID | Term |
|---|---|
| D007248 | Infertility, Male |
| ID | Term |
|---|---|
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007246 | Infertility |
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| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D002331 | Carnitine |
| ID | Term |
|---|---|
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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| Control Dietary Supplement | 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 |
|
| D052801 |
| Male Urogenital Diseases |
| D050337 |
| Trimethyl Ammonium Compounds |
| D000644 | Quaternary Ammonium Compounds |
| D000588 | Amines |
| D009930 | Organic Chemicals |