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).
Conditions
Interventions
Not applicable.
Sponsors
Erasmus MC
Eligibility
Inclusion criteria
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
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 outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine whether methotrexate (solely or as polyglutamate) can be quantified in seminal fluid and spermatozoa of users. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Contacts
Public ContactLuis Perez
Erasmus MC
Outcome results
None listed