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NCT02461784 · ClinicalTrials.gov registry record
The Effect of Methotrexate on Sperm Quality in Men With Inflammatory Bowel Disease
A clinical trial, sponsored by University of Wisconsin, Madison.
- Terminated
- Registry status
- 30
- Enrollment target
NCT02461784 is a clinical trial that was terminated before completion, run by University of Wisconsin, Madison. The registered enrollment target is 30 participants.
The verdict
NCT02461784 was terminated before completion, sponsored by University of Wisconsin, Madison.
- TERMINATED
- Registry status
- 30 participants
- Enrollment target
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.
Interventions
- PROCEDURE Semen & Data Collection
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2016-01-21 |
| Est. Completion | 2020-03-10 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02461784
The ClinicalTrials.gov registry entry for NCT02461784 describes a study currently listed as terminated, categorized as an unspecified phase. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Wisconsin, Madison, which has 1,039 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Semen & Data Collection is the first listed.
NCT02461784 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02461784 about?
NCT02461784 is a clinical study titled "The Effect of Methotrexate on Sperm Quality in Men With Inflammatory Bowel Disease". 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 deci...
What is the current status of trial NCT02461784?
This trial is currently terminated. The enrollment target is 30 participants. The study started on 2016-01-21. Estimated completion is 2020-03-10.
What interventions are being tested in trial NCT02461784?
The interventions under investigation include: Semen & Data Collection (PROCEDURE).
Who is sponsoring clinical trial NCT02461784?
This trial is sponsored by University of Wisconsin, Madison, which has 1,039 total clinical trials registered on ClinicalTrials.gov.
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