The Effect of Methotrexate on Sperm Quality in Men With Inflammatory Bowel Disease
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Compare semen characteristics between male IBD patients on Methotrexate and non-methotrexate exposed males.
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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.
- •Individual able and willing to consent to donate their sperm to research.
排除标准
- •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)
- •Current use of alkylating agents, ketoconazole, sulfalsalazine, H2-receptor antagonists or spironolactone
- •Men who have undergone ileal pouch anal anastomosis within 3 months of study entry
结局指标
主要结局
Compare semen characteristics between male IBD patients on Methotrexate and non-methotrexate exposed males.
时间窗: 12 month study
The purpose of this study is to determine whether the treatment of IBD patients with MTX is associated with an increased risk for infertility using two different criteria for assessing male fertility: the WHO criteria for basic semen analysis and Fourier Harmonic Amplitudes. The latter will be used to describe nuclear shapes and sperm DNA staining intensity as this has been shown in animal models to correlate with male fertility. MTX-exposed male IBD patients (cases) will be compared with age-matched, non-MTX exposed patients (controls).
次要结局
未报告次要终点