No registrations found.
ID
Source
Brief title
Health condition
Immune-mediated diseases such as Rheumatoid Arthritis (RA), Spondyloartropathies (SpA), Juvenile Idiopathic Arthritis (JIA), Undifferentiated Arthritis (UA), Psoriasis (PsO), eczema (E) and Crohn’s Disease (CD).
Sponsors and support
Intervention
Outcome measures
Primary outcome
To determine whether methotrexate (solely or as polyglutamate) can be quantified in seminal fluid and spermatozoa of users.
Secondary outcome
Determine if there is a statistically significant difference on DNA Fragmentation Index between cases and study-controls.
Evaluate the associations between MTX concentration (solely or as polyglutamate) in seminal plasma and spermatozoa with those in serum and erythrocytes and with the traditional sperm quality measurements and the DNA Fragmentation Index.
Background summary
Rationale: Methotrexate (MTX) is the cornerstone in the treatment of several immune mediated diseases, such as Inflammatory Arthritis, Psoriasis and Crohn’s Disease. Besides being teratogenic, MTX may also have a negative impact on sperm quality. Recommendations for the use of MTX in men wishing to conceive are inconclusive, mainly because of the lack of studies about the impact of MTX on semen and spermatozoa.
Objective:
To determine whether MTX can be quantified in seminal plasma and spermatozoa of users and to evaluate the effect of MTX concentration on parameters of sperm quality, including the DNA fragmentation index (DFI).
Study design:
This is a case-control study. Twenty five adult male patients with immune mediated diseases (such as: rheumatoid arthritis, undifferentiated arthritis, spondyloartropathies, juvenile idiopathic arthritis, psoriasis, eczema and Crohn’s disease) who will start treatment with MTX will be included as cases. Specialists from several hospitals in the Rotterdam area will be involved in the recruitment of the cases. Twenty five adult healthy men will be recruited as study-controls. In cases, the MTX concentration in blood, seminal plasma and spermatozoa will be measured at baseline and 12 weeks later. Cases and study-controls will go through the same andrological evaluation, consisting of a physical examination, medical history, endocrine evaluation, semen quality analysis and DFI.
Main study parameters/endpoints:
To determine whether MTX can be quantified in seminal plasma and spermatozoa of users, and whether DFI is increased in relation to MTX.
Study objective
We hypothesize that MTX can be quantified in semen and that it is associated with measures of semen quality and DNA fragmentation
Study design
Not applicable
Intervention
Not applicable.
Inclusion criteria
Cases
• Males 18 years or older.
• Diagnosed with an immune mediated disease such as:
1. Rheumatoid Arthritis (RA)
2. Spondyloarthropathies (SpA)
3. Ankylosing Spondylitis (AS)
4. Psoriasis (PsO)
5. Eczema (E)
• MTX-naive patients (i.e. no MTX treatment in the six months before inclusion) who will start MTX therapy (oral and subcutaneous routes of administration are allowed).
• Proven fertility, i.e. the man impregnated a woman (positive pregnancy test) in the past or who has biological children of his own (self-report).
• Able to give informed consent.
Study-controls
• Males 18 years or older.
• Proven fertile i.e. the man impregnated a woman (positive pregnancy test) in the past or who has biological children of his own (self-report).
• Able to give informed consent.
Exclusion criteria
Cases
• Age above 50 years.
• Known infertility (Self-report).
• Current use of the following drugs: Methadone hydrochloride, Nitrofurantoin, Dapsone, Paroxetine, Fluvoxamine maleate, Nifedipine, Colchicine, Cortisone acetate, Dexamethasone, Methylprednisone, Prednisone (>7.5 mg/day), Sulfasalazine, Triamcinolone hexacetonide, Busulfan, Chlorambucil, Cyclophosphamide, Dabrafenib, Degarelix, Fludarabine, Mercaptopurine,
Procarbazine, Triptorelin, Vinblastine, Vinorelbine, Testosterone.
• Current sexually transmitted disease (Self-report).
• Current lower urinary tract infection (Self-report).
• Active infection with Hepatitis B or C virus (Self-report).
• Human immunodeficiency virus (HIV) infection (Self-report).
• Vasectomy.
• Language barrier.
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL8674 |
| Other | METC Erasmus MC : MEC-2018-082 |