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

University of Wisconsin (UW)

Status: Terminated

Conditions: Inflammatory Bowel Disease (IBD)

Treatments: Procedure: Semen & Data Collection

Study type: Observational

Funder types: Other

Identifiers

NCT02461784

MTX/Sperm in IBD (Other Identifier)

SMPH\MEDICINE\GASTROENT (Other Identifier)

2015-0487

A534250 (Other Identifier)

Protocol Version 8/24/2015 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: Male

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

30 participants in 2 patient groups

Case

Description:

Male subjects with IBD diagnosis currently taking methotrexate (MTX) as treatment for their disease.

Treatment:

Procedure: Semen & Data Collection

Control

Description:

Male subjects with IBD diagnosis not exposed to methotrexate (MTX) as treatment for their disease.

Treatment:

Procedure: Semen & Data Collection