The Effect of Methotrexate on Sperm Quality in Men With Inflammatory Bowel Disease
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- STATUS
- Recruiting
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- End date
- Dec 20, 2023
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- participants needed
- 150
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- sponsor
- University of Wisconsin, Madison
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.
Details
| Condition | Inflammatory Bowel Disease (IBD) |
|---|---|
| Treatment | Semen & Data Collection |
| Clinical Study Identifier | NCT02461784 |
| Sponsor | University of Wisconsin, Madison |
| Last Modified on | 4 October 2022 |
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