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

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ClinicalTrials.gov Identifier: NCT02461784
Recruitment Status : Recruiting
First Posted : June 3, 2015
Last Update Posted : November 1, 2016
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison

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.


Condition or disease Intervention/treatment
Inflammatory Bowel Disease (IBD) Procedure: Semen & Data Collection

Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: The Effect of Methotrexate on Sperm Quality in Men With Inflammatory Bowel Disease
Study Start Date : June 2015
Estimated Primary Completion Date : July 2017
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Case
Male subjects with IBD diagnosis currently taking methotrexate (MTX) as treatment for their disease.
Procedure: Semen & Data Collection

If participants decide to participate in this research they will be asked to complete the informed consent process as well as asked a few questions such as age and race/ethnicity. If participants volunteered for this study because tehy have IBD, investigators will also collect some information from the participants medical record. Completing this portion of participation will take less than 1 hour.

Participants will then be scheduled to complete the semen collection at the UW Health Generations Fertility Clinic located at 2365 Deming Way in Middleton, WI. This collection visit will take less than 1 hour to complete. Once participants have finished the collection visit they will have completed their participation in this research project.


Control
Male subjects with IBD diagnosis not exposed to methotrexate (MTX) as treatment for their disease.
Procedure: Semen & Data Collection

If participants decide to participate in this research they will be asked to complete the informed consent process as well as asked a few questions such as age and race/ethnicity. If participants volunteered for this study because tehy have IBD, investigators will also collect some information from the participants medical record. Completing this portion of participation will take less than 1 hour.

Participants will then be scheduled to complete the semen collection at the UW Health Generations Fertility Clinic located at 2365 Deming Way in Middleton, WI. This collection visit will take less than 1 hour to complete. Once participants have finished the collection visit they will have completed their participation in this research project.





Primary Outcome Measures :
  1. Compare semen characteristics between male IBD patients on Methotrexate and non-methotrexate exposed males. [ Time Frame: 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).



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The subject population will consist of individuals with inflammatory bowel disease
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02461784


Contacts
Contact: Jenny Vue 608-263-4185 jxvue@medicine.wisc.edu
Contact: Sumona Saha 608-263-4185 ssaha@medicine.wisc.edu

Locations
United States, Wisconsin
University of Wisconsin Hospital & Clinics Recruiting
Madison, Wisconsin, United States, 53792
Contact: Jenny Vue    608-263-4185    jxvue@medicine.wisc.edu   
Contact: Sumona Saha    608-263-4185    ssaha@medicine.wisc.edu   
Sponsors and Collaborators
University of Wisconsin, Madison

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT02461784     History of Changes
Other Study ID Numbers: 2015-0487
MTX/Sperm in IBD ( Other Identifier: UW-Madison Study Staff )
First Posted: June 3, 2015    Key Record Dates
Last Update Posted: November 1, 2016
Last Verified: October 2016

Additional relevant MeSH terms:
Intestinal Diseases
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Methotrexate
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors