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The Effect of Methotrexate on Sperm Quality in Men With Inflammatory Bowel Disease

NCT02461784 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2023-03-09

No results posted yet for this study

Summary

Inflammatory bowel disease (IBD) is a chronic inflammatory disorder of the gastrointestinal tract which includes Crohn's disease (CD) and ulcerative colitis (UC) which peak in incidence (rate or frequency) during the reproductive years. An increasing number of young people will face challenging decisions regarding medical management of this chronic disease during a period of time when they are still completing schooling, establishing their career, and/or are building a family.

Treatment options for IBD consist of immunosuppressive therapy, such as immunomodulators (azathioprine and methotrexate). Methotrexate (MTX) is a folic acid antagonist (a substance that interferes with or inhibits the action of another). It is thought that MTX works by decreasing the inflammation in the gastrointestinal tract. MTX has been studied for many years and in used as treatment in not only IBD, but also in conditions such as rheumatoid arthritis and lupus. However, due to concerns about the safety of MTX, particularly in regards to fertility and pregnancy has limited its current use.

Participants are invited to take part in this research project to determine whether the treatment of IBD patients with MTX is associated with an increased risk for infertility. Investigators will recruit 75 male IBD patients under MTX treatment for their IBD as well as 75 healthy male controls for a total of 150 patients at the University of Wisconsin Hospital \& Clinics.

Conditions

  • Inflammatory Bowel Disease (IBD)

Interventions

PROCEDURE

Semen & Data Collection

If participants decide to participate in this research they will be asked to complete the informed consent process as well as asked a few questions such as age and race/ethnicity. If participants volunteered for this study because tehy have IBD, investigators will also collect some information from the participants medical record. Completing this portion of participation will take less than 1 hour. Participants will then be scheduled to complete the semen collection at the UW Health Generations Fertility Clinic located at 2365 Deming Way in Middleton, WI. This collection visit will take less than 1 hour to complete. Once participants have finished the collection visit they will have completed their participation in this research project.

Sponsors & Collaborators

  • University of Wisconsin, Madison

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-21
Primary Completion
2020-03-10
Completion
2020-03-10

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02461784 on ClinicalTrials.gov