DRKS00003407
Active, not recruiting
未知
Project B4: Infertility and inflammatory urogenital diseases as a result of the metabolic syndrome - male infertility due to infection and inflammation - MIBIE
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Metabolic Syndrom
- Sponsor
- Justus Liebig Universität Gießen
- Enrollment
- 6
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •age \> 18 years, male
- •metabolic syndrome according to International Diabetes Federation (IDF):
- •\- adiposity: waist circumference \> 94 cm (European), and 2 of the following criteria:
- •\- triglyceride \> 150 mg/dl (fasting)
- •\- HDL\-cholesterol \< 40 mg/dl or treated by antilipemics (fasting)
- •\- bloodpresssure \> 130/\> 85 mmHg or treated hypertonia
- •\- fasting blood sugar \> 100 mg/dl or
- •known diabetes
Exclusion Criteria
- •noncompliance to criteria of metabolic syndrome (e.g. diabetes type 1\)
- •Diseases, which might jeopardize patients safety
- •Condition after sterilisation or refertilization
- •Diseases or medicaments, which might obstruct the coduct of the trial (e.g. addiction, psychotic and tumourous diseases, systemic intake of glucocorticoids)
- •Participation in another trial according to AMG
Outcomes
Primary Outcomes
Not specified
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Infertility and inflammatory diseases of the urinary- and sex organs as a result of diabetes, hypertony, dislepidaemia and overweight (metabolic syndrome)infertility and inflammatory urogenital diseases as a result of the metabolic syndromeMedDRA version: 14.0Level: PTClassification code 10046694Term: Urogenital disorderSystem Organ Class: 10038359 - Renal and urinary disordersMedDRA version: 14.0Level: PTClassification code 10052066Term: Metabolic syndromeSystem Organ Class: 10027433 - Metabolism and nutrition disordersMedDRA version: 14.0Level: PTClassification code 10021926Term: InfertilitySystem Organ Class: 10038604 - Reproductive system and breast disordersTherapeutic area: Diseases [C] - Male diseases of the urinary and reproductive systems [C12]EUCTR2011-000624-16-DEJustus Liebig Universität Gießen60
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