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The Effect of Infliximab on Sperm Quality

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ClinicalTrials.gov Identifier: NCT00745329
Recruitment Status : Unknown
Verified September 2008 by Tel-Aviv Sourasky Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : September 3, 2008
Last Update Posted : September 3, 2008
Information provided by:
Tel-Aviv Sourasky Medical Center

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 .

Condition or disease Intervention/treatment
Crohn's Disease Ulcerative Colitis Other: sperm quality test

Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: The Effect of Infliximab,Adalimumab, Azathioprines and 5-Aminosalicylate on Semen Quality in Men With Inflammatory Bowel Disease
Study Start Date : October 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Infliximab
U.S. FDA Resources

Group/Cohort Intervention/treatment
  1. patients
  2. healthy volunteers
Other: sperm quality test
All participants will undergo sequential sperm quality tests and blood tests

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients with inflammatory bowel disease (IBD) and 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

Responsible Party: Dr Sigal Fishman Gastroenterology institution Tel Aviv Sourasky Medical Center, Tel Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT00745329     History of Changes
Other Study ID Numbers: TASMC-08-SF-182-CTIL
First Posted: September 3, 2008    Key Record Dates
Last Update Posted: September 3, 2008
Last Verified: September 2008

Additional relevant MeSH terms:
Crohn Disease
Colitis, Ulcerative
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Colonic Diseases
Dermatologic Agents
Gastrointestinal Agents
Antirheumatic Agents