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NCT00745329 Clinical Trial

The Effect of Infliximab on Sperm Quality

Ulcerative Colitis Clinical Trial

Official title:
The Effect of Infliximab,Adalimumab, Azathioprines and 5-Aminosalicylate on Semen Quality in Men With Inflammatory Bowel Disease

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT00745329
Other study ID # TASMC-08-SF-182-CTIL
Secondary ID
Status Not yet recruiting
Phase N/A
First received September 1, 2008
Last updated September 2, 2008
Start date October 2008

Study information
Verified date September 2008
Source Tel-Aviv Sourasky Medical Center
Contact n/a
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Observational

Clinical Trial Summary

Background: The treatment of inflammatory bowel diseases (IBD) is based mainly on 3 compounds: 1- 5 aminosalysilates . 2- immunomodulators (Azathioprines). 3- Biologic therapies (Infliximab, Adalimumab) . There are no established data in the literature whether these therapies effects sperm quality. Given that a large number of the patients are young men in the reproductive stage of their lives , It of importance to investigate these effect.

Aim: To investigate the effect of chronic treatment of any of the three therapy mentioned above, on sperm quality .

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 100
Est. completion date
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Male above the age of 18

- Capable of giving informed consent

- Diagnosed with IBD at least 3 months

- Patients that are going to start a treatment with on of the following groups: 5ASA, Azathioprines, infliximab or ADAlimumab

- Patients that are treated with therapies mentioned in article 4 for at least 3 months

Exclusion Criteria:

- Male younger than 18

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Other:
• sperm quality test
All participants will undergo sequential sperm quality tests and blood tests

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Tel-Aviv Sourasky Medical Center
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