Clinical trial NCT02461784: The Effect of Methotrexate on Sperm Quality in Men With Inflammatory Bowel Disease
Official title: The Effect of Methotrexate on Sperm Quality in Men With Inflammatory Bowel Disease
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Inflammatory Bowel Disease (IBD)
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2015-06-03
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The subject population will consist of individuals with inflammatory bowel disease

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Compare semen characteristics between male IBD patients on Methotrexate and non-methotrexate exposed males.
timeFrame: 12 month study
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin Hospital & Clinics
state: Wisconsin
Study officials:
References: