The Effect of Infliximab on Sperm Quality

NCT00745329 | Unknown

• 1 other identifier: TASMC-08-SF-182-CTIL
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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 .

Conditions

Crohn's Disease; Ulcerative Colitis

Study Arms (1)

2

1. patients 2. healthy volunteers

Other: sperm quality test

Interventions

sperm quality test OTHER

All participants will undergo sequential sperm quality tests and blood tests

2

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with inflammatory bowel disease (IBD) and healthy volunteers

You may qualify if:

• 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

You may not qualify if:

• Male younger than 18

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead

MeSH Terms

Conditions

Crohn Disease; Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: September 1, 2008
• First Posted: September 3, 2008
• Study Start: October 1, 2008
• Last Updated: September 3, 2008

Record last verified: 2008-09