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The Effect of Infliximab on Sperm Quality

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2008 by Tel-Aviv Sourasky Medical Center.
Recruitment status was:  Not yet recruiting
Information provided by:
Tel-Aviv Sourasky Medical Center Identifier:
First received: September 1, 2008
Last updated: September 2, 2008
Last verified: September 2008

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 Intervention
Crohn's Disease Ulcerative Colitis Other: sperm quality test

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Tel-Aviv Sourasky Medical Center:

Estimated Enrollment: 100
Study Start Date: October 2008
Groups/Cohorts Assigned Interventions
  1. patients
  2. healthy volunteers
Other: sperm quality test
All participants will undergo sequential sperm quality tests and blood tests


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
  Contacts and Locations
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No Contacts or Locations Provided
  More Information

Responsible Party: Dr Sigal Fishman Gastroenterology institution Tel Aviv Sourasky Medical Center, Tel Aviv Sourasky Medical Center Identifier: NCT00745329     History of Changes
Other Study ID Numbers: TASMC-08-SF-182-CTIL
Study First Received: September 1, 2008
Last Updated: September 2, 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 processed this record on August 16, 2017