Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000153718
Ethics application status
Approved
Date submitted
6/02/2013
Date registered
8/02/2013
Date last updated
8/02/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Association between chronic prostatitis and sperm disorders.
Scientific title
Correlation between sperm DNA fragmentation and sperm abnormalities in chronic prostatitis patients.
Secondary ID [1] 281805 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic prostatitis-Chronic pelvic pain syndrome (CPPS) 288140 0
Condition category
Condition code
Reproductive Health and Childbirth 288512 288512 0 0
Fertility including in vitro fertilisation

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Chronic prostatitis-Chronic pelvic pain syndrome (CPPS)patients in II, IIIa and IIIb categories according to NIDDK (NIH) classification, investigated for sperm abnormalities and correlation of these abnormalities with DNA Fragmentation Index (DFI) determinated by TUNEL technique
TUNEL is a common method for detecting DNA fragmentation that results from apoptotic signaling cascades. The assay relies on the presence of nicks in the DNA which can be identified by terminal deoxynucleotidyl transferase or TdT, an enzyme that will catalyze the addition of dUTPs that are secondarily labeled with a marker. It may also label cells that have suffered severe DNA damage. This examination is going to be performed the 3-5 days after the first clinical examination
Every patient is going to be observed for 7-10 days, time necessary to have the final results of the sperm culture, urine analysis and culture, spermogram, and estimation of DNA fragmantation Index.
Intervention code [1] 286352 0
Not applicable
Comparator / control treatment
Single group trial
Control group
Uncontrolled

Outcomes
Primary outcome [1] 288668 0
Evaluate DFI determinated by TUNEL technique in CPPS patients
Timepoint [1] 288668 0
Immediately after diagnosis of CPPS (between 5th and 7th day from the first clinical examination)
Secondary outcome [1] 300733 0
Categorization of the patients in the various categories of chronic prostatitis
(Categories II, IIIA and IIIB by NIH (NIDDK)).
Category II: Chronic bacterial prostatitis
Category III: Chronic abacterial prostatitis
- IIIA infiammatory
- IIIB non infiammatory
(with the present or not of infiammatory cells in
the prostatic fluid)

These parameters are going to be assessed by:
Urine analysis and urine culture before and after massage of the prostate in assotiation with semen culture.
Timepoint [1] 300733 0
Urine analysis and urine culture before and after prostate massage are going to be examined during the first examination.
Semen culture are going to be examined the day after the first clinical examination.
Secondary outcome [2] 300739 0
The level of the patients fertility.
This is going to be assessed by Spermogram
Timepoint [2] 300739 0
Sperm for Spermogram are going to be selected after 3 days absence of sexual activity.
This exam is going to be done once.
Secondary outcome [3] 300740 0
Correlation of the symptoms duration and the level of the fertility
Timepoint [3] 300740 0
The last day (5th or 7th day) after the evaluation of all the laboratory exams

Eligibility
Key inclusion criteria
- History of chronic pelvic pain for three or more months
- Rating Questionnaire «NIH Chronic Prostatitis Symptom Index», over 3
(this Questionnaire is composed by 9 questions relative with the modality of pain, the sense of urine and the quality of life)
- Physical and mental condition of the patient such that they can cooperate with the physician-researcher.
Minimum age
18 Years
Maximum age
45 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
- Suffering from an acute infection of the genitourinary
- Undergoing Chemotherapy
- Suffering from varicocele
- Have been treated for in less than three months for varicocele, torsion or testicular injury
- History of cryptorchidism
- Hisrory of testicular cancer
- Subjected to some systemic medication the last 3 months
- Smoking more than 10 cigarettes a day
- Clinical signs of epididymitis

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/05/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment outside Australia
Country [1] 4810 0
Greece
State/province [1] 4810 0

Funding & Sponsors
Funding source category [1] 286596 0
Self funded/Unfunded
Name [1] 286596 0
Country [1] 286596 0
Primary sponsor type
Hospital
Name
General Hospital of Thessaloniki “G. Gennimatas”
Address
41 Ethnikis Aminis
54643 Thessaloniki
Country
Greece
Secondary sponsor category [1] 285379 0
None
Name [1] 285379 0
Address [1] 285379 0
Country [1] 285379 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
The aim of our study is to identify each of the three categories of CPPS II, IIIA and IIIB patients according to NIDDK (NIH) classification, to investigate their sperm DFI and to correlate it with potential abnormalities in their sperm, with the DFI of general and infertile men population, thus to provide useful informations for potential association of CPPS and male infertlity.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 37186 0
Mr KOPTSIS MICHAIL
Address 37186 0
7 Thermopylon,
56122 Menemeni,
Thessaloniki
Country 37186 0
Greece
Phone 37186 0
+302310963105
Fax 37186 0
Email 37186 0
mkoptsis@libero.it
Contact person for public queries
Name 37187 0
Mr KOPTSIS MICHAIL
Address 37187 0
7 Thermopylon,
56122 Menemeni,
Thessaloniki
Country 37187 0
Greece
Phone 37187 0
+306936758482
Fax 37187 0
Email 37187 0
mkoptsis@libero.it
Contact person for scientific queries
Name 37188 0
Mr KOPTSIS MICHAIL
Address 37188 0
7 Thermopylon,
56122 Menemeni,
Thessaloniki
Country 37188 0
Greece
Phone 37188 0
+306936758482
Fax 37188 0
Email 37188 0
mkoptsis@libero.it

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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Documents added automatically
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