The Effect of Infliximab on Sperm Quality

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2008 by Tel-Aviv Sourasky Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT00745329
First received: September 1, 2008
Last updated: September 2, 2008
Last verified: September 2008
  Purpose

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
2
  1. patients
  2. healthy volunteers
Other: sperm quality test
All participants will undergo sequential sperm quality tests and blood tests

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Patients with inflammatory bowel disease (IBD) and healthy volunteers

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

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
Study First Received: September 1, 2008
Last Updated: September 2, 2008
Health Authority: Israel: Ministry of Health

Additional relevant MeSH terms:
Colitis
Colitis, Ulcerative
Crohn Disease
Inflammatory Bowel Diseases
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Infliximab
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
Gastrointestinal Agents
Antirheumatic Agents
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on July 28, 2014