The Effect of Infliximab on Sperm Quality

Tel Aviv Sourasky Medical Center

Status: Unknown

Conditions: Ulcerative Colitis; Crohn's Disease

Treatments: Other: sperm quality test

Study type: Observational

Funder types: Other

Identifiers

NCT00745329

TASMC-08-SF-182-CTIL

Details and patient eligibility

About

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 .

Enrollment: 100 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

100 participants in 1 patient group

2

Description:

1. patients 2. healthy volunteers

Treatment:

Other: sperm quality test