fertility
Conditions
Interventions
None listed
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: SEMEN VALIDATION-CONTROLS * Males 18 years or older. * Able to give informed consent. BLOOD VALIDATION-CONTROLS * Males 18 years or older. * Current MTX-users for at least 3 consecutive months. * Able to give informed consent. CASES * Males 18 years or older. * Diagnosed with an immune mediated disease, such as: - Rheumatoid Arthritis (RA). - Undifferentiated arthritis (UA). - Spondyloarthropathies (SpA): * Psoriatic Arthritis (PA) * Ankylosing Spondylitis (AS) * Reactive Arthritis (ReA) * Enteropathic Arthritis (EA) * Undifferentiated Spondylarthropathy (US) - Juvenile Idiopathic Arthritis (JIA) - Psoriasis (PsO) - Eczema (E) - Crohn*s Disease (CD) * Methotrexate-naive patients: patients who will start methotrexate therapy (oral and subcutaneous routes of administration are allowed) and who have not received MTX treatment in the 6 months before inclusion. * Chronic-MTX users: patients who are currently under treatment with MTX uninterruptedly for at least 1 year using a dose equal or higher than 15 mg/week. * 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. ENZYME-CONTROLS * Males 18 years or older. * Able to give informed consent.
Exclusion criteria
Exclusion criteria: SEMEN VALIDATION-CONTROLS * Current or past use of Methotrexate. * Vasectomy. * Language barrier. BLOOD VALIDATION-CONTROLS * Language barrier. CASES * Age above 55 years. * Known infertility (Self-report). * Current use of 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. STUDY-CONTROLS * Age above 55 years. * Known infertility (Self-report). * Current or past use of Methotrexate. * Current use of any medication. * 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. ENZYME-CONTROLS * 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 naïve and chronic users. * To compare the concentration of methotrexate in seminal fluid and spermatozoa between MTX-naïve users and MTX-chronic 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. * Determine if there is a time and dose dependent effect on traditional sperm quality measurements and the DNA Fragmentation Index. * Compare the concentration and the activity of GGH and other enzymes responsible for the intracellular metabolism of MTX in spermatozoa with those found in red and white blood cells. | — |
Countries
Netherlands
Outcome results
None listed