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 syndrome Male infertility with infection and inflammation -MIBIE- - MIBIE

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-000624-16-DE

Enrollment

Registered

2011-09-05

Start date

2011-11-28

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

infertility and inflammatory urogenital diseases as a result of the metabolic syndrome MedDRA version: 14.0 Level: PT Classification code 10046694 Term: Urogenital disorder System Organ Class: 10038359 - Renal and urinary disorders MedDRA version: 14.0 Level: PT Classification code 10052066 Term: Metabolic syndrome System Organ Class: 10027433 - Metabolism and nutrition disorders MedDRA version: 14.0 Level: PT Classification code 10021926 Term: Infertility System Organ Class: 10038604 - Repro

Interventions

Product Name: Atorvastatin Pharmaceutical Form: Tablet INN or Proposed INN: ATORVASTATIN CAS Number: 134523-00-5 Concentration unit: mg milligram(s) Concentration type: range Concentration number: 10-

Eligibility

Sex/Gender

Male

Inclusion 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 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

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

Design outcomes

Primary

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

Measure

Time frame

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

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

Measure

Time frame

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

—

Countries

Germany

Contacts

Public ContactProf. Dr. med. Thomas Linn

Klinische Forschungseinheit Med. Klinik und Poliklinik 3

Thomas.Linn@innere.med.uni-giessen.de0049641985 42841

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026