Inflammatory bowel diseases Crohn's disease Ulcerative colitis Thiopurines Fertility Paternal exposure
Conditions
Interventions
None
Patients will start thopurines regarding treatment of inflammatory bowel diseases
Sponsors
TEVA Pharmaceuticals B.V.
Eligibility
Inclusion criteria
Inclusion criteria: All male Crohn’s disease or ulcerative colitis patients, aged between 18 and 50 years who will be treated with thiopurines, without prior exposure to thiopurines or possible spermatotoxic drugs
Exclusion criteria
Exclusion criteria: Subject with prior treatment with thiopurines in three months before inclusion, prior treatment with possible spermatotoxic drugs (e.g. sulfasalazine, tacrolimus, busulfan, chlorambucil, cyclophosphamide, cyclosporine) or male patients with a known history of subfertility or infertility.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Differences in semen quality defined as sperm density, motility, morphology, ejaculation volume and total sperm count, prior to and during thiopurine exposure | — |
Secondary
| Measure | Time frame |
|---|---|
| The influence of thiopurines on paternally exposed offspring in terms of adverse pregnancy and birth outcomes (pre-term birth, low-birth weight, spontaneous abortions, congenital anomalies). | — |
Contacts
Public ContactM. Simsek
Department of Gastroenterology and Hepatology, VU University Medical Centre Amsterdam
Outcome results
None listed