Infertility and inflammatory diseases of the urinary- and sex organs as a result of diabetes, hypertony, dislepidaemia and overweight (metabolic syndrome)

• Conditions: infertility and inflammatory urogenital diseases as a result of the metabolic syndrome; MedDRA version: 14.0Level: PTClassification code 10046694Term: Urogenital disorderSystem Organ Class: 10038359 - Renal and urinary disorders; MedDRA version: 14.0Level: PTClassification code 10052066Term: Metabolic syndromeSystem Organ Class: 10027433 - Metabolism and nutrition disorders; MedDRA version: 14.0Level: PTClassification code 10021926Term: InfertilitySystem Organ Class: 10038604 - Reproductive system and breast disorders; Therapeutic area: Diseases [C] - Male diseases of the urinary and reproductive systems [C12]

• Registration Number: EUCTR2011-000624-16-DE
• Lead Sponsor: Justus Liebig Universität Gießen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09-05
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Male
• Target Recruitment: 60

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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

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 clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Primary objective<br>Difference of spermatozoa concentration in the ejaculate between baseline and 12 months follow-up visit [millions/ml]<br>;Secondary Objective: Secondary objectives<br>•Pregnancy rate primary/ secondary<br>•Spermatozoa mobility (%)<br>•Normal formed Spermatozoa (%)<br>•Inflammation scores of ejaculate, consisting of cellular and humoral parameters<br>•Change of the hormone levels of FSH, LH and testosterone in blood serum in the course of the study<br>•Effects on the sonographic investigations of prostate gland and testicles<br>•Influence of the age of the manifestation of the metabolic syndrome on fertility<br>•Complaint scores, as Prostatitis questionnaire NIH-CPSI<br>•Change of blood pressure, blood glucose, blood fat, body weight, sCRP<br><br> <br>;Primary end point(s): Difference of spermatozoa concentration in the ejaculate between baseline and 12 months follow-up visit [millions/ml];Timepoint(s) of evaluation of this end point: end of study

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): •Pregnancy rate primary/ secondary<br>•Spermatozoa mobility (%)<br>•Normal formed Spermatozoa (%)<br>•Inflammation scores of ejaculate, consisting of cellular and humoral parameters<br>•Change of the hormone levels of FSH, LH and testosterone in blood serum in the course of the study<br>•Effects on the sonographic investigations of prostate gland and testicles<br>•Influence of the age of the manifestation of the metabolic syndrome on fertility<br>•Complaint scores, as Prostatitis questionnaire NIH-CPSI<br>•Change of blood pressure, blood glucose, blood fat, body weight, sCRP<br><br>;Timepoint(s) of evaluation of this end point: end of study