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The Effect of Infliximab on Sperm Quality

NCT ID: NCT00745329

Last Updated: 2008-09-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-10-31

Brief Summary

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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 .

Detailed Description

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Conditions

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Crohn's Disease Ulcerative Colitis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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2

1. patients
2. healthy volunteers

sperm quality test

Intervention Type OTHER

All participants will undergo sequential sperm quality tests and blood tests

Interventions

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sperm quality test

All participants will undergo sequential sperm quality tests and blood tests

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Tel-Aviv Sourasky Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Tel Aviv Sourasky Medical Center

Other Identifiers

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TASMC-08-SF-182-CTIL

Identifier Type: -

Identifier Source: org_study_id