Project B4: Infertility and inflammatory urogenital diseases as a result of the metabolic syndrome - male infertility due to infection and inflammatio

Not Applicable

• Conditions: Metabolic Syndrom; E88.9; N46; E66; Metabolic disorder, unspecified; Male infertility; Obesity

• Registration Number: DRKS00003407
• Lead Sponsor: Justus Liebig Universität Gießen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12-22
• Study Completion: 2014-06-03
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting stopped after recruiting started
• Sex: Male
• Target Recruitment: 6

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Increase of the spermatozoa concentration in the ejaculate between baseline and 12 months follow-up visit <br>to get the required information ejaculate testing will be performed at baseline and at the 12 months follow-up visit

Secondary Outcome Measures

Name	Time	Method
pregnancy rate primary/secondary; spermatozoa motility (%); normal formed spermatozoa (%); inflammation parameters in the ejaculate (cellular and humoral parameters); serum level alteration of FSH, LH and testosterone; results of the 2-Gläser-Probe; impact on sonographic investigations of prostate and testicle; Impact of the manifestation age of the metabolic syndrom on fertility; discomfort scores as NIH-CPSI; <br>Prostatitis-questionnaire; Alteration of: bloodpressure, blood suger level, blood lipid level; weight; sCRP; <br>To get the required information blood testing, urine tests, ejaculate tests, sonographic tests and patient questioning will be performed at the planned study visits<br><br>