The Effect of Methotrexate on Sperm Quality in Men With Inflammatory Bowel Disease
| Status: | Recruiting |
|---|---|
| Conditions: | Irritable Bowel Syndrome (IBS), Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - 40 |
| Updated: | 1/11/2019 |
| Start Date: | June 2015 |
| End Date: | July 2020 |
| Contact: | Lindsay Luedke |
| Email: | leluedke@medicine.wisc.edu |
| Phone: | 608-263-4185 |
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.
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.
Inclusion Criteria:
1. Cases: Men aged 18 to 40 years with a confirmed diagnosis of UC or CD based on
endoscopy, pathology, and/or radiology AND who regularly take MTX (per oral,
subcutaneous, or intramuscular) either as monotherapy or in combination with
mesalamine (any except sulfasalazine), corticosteroids, anti-TNF agents, or
anti-adhesion molecules for at least one month specifically for the treatment of IBD.
Controls: Men aged 18 to 40 years with a confirmed diagnosis of UC or CD based on
endoscopy, pathology, and/or radiology AND who do not take MTX (per oral,
subcutaneous, or intramuscular) either as monotherapy or in combination with other
IBD-specific drugs.
2. Individual able and willing to consent to donate their sperm to research.
Exclusion Criteria:
1. Men with previously documented problems with male reproductive health such as known
hypothalamic-pituitary disorders (e.g. pituitary macroadenomas, pituitary infarction),
primary hypogonadism (e.g. cryptorchidism, Klinefelter's syndrome), or disorders of
sperm transport (e.g. erectile dysfunction, history of vasectomy)
2. Current use of alkylating agents, ketoconazole, sulfalsalazine, H2-receptor
antagonists or spironolactone
3. Men who have undergone ileal pouch anal anastomosis within 3 months of study entry
We found this trial at
1
site
600 Highland Ave
Madison, Wisconsin 53792
Madison, Wisconsin 53792
(608) 263-6400
Phone: 608-263-4185
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