The hypothesis is that patients with thiopurine therapy will not be at risk of impaired semen quality.
ID
Bron
Verkorte titel
Aandoening
Inflammatory bowel diseases
Crohn's disease
Ulcerative colitis
Thiopurines
Fertility
Paternal exposure
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Differences in semen quality defined as sperm density, motility, morphology, ejaculation volume and total sperm count, prior to and during thiopurine exposure
Achtergrond van het onderzoek
Thiopurines are widely used immunosuppressive agents. In high dosages, they inhibit the purine synthesis and are considered to be possibly harmful to spermatogenesis, and subsequently to men’s fertility and their offspring. However, the clear association between thiopurine exposure and male fertility and reproduction safety, if any, is still poorly understood.
Appropriate counselling with regard to fertility, conception, and the possible effects of paternal thiopurine use, is essential in the management of IBD in potential fathers. Therefore the main objective of this study is to assess the effects of thiopurine exposure on the quality of semen in IBD-patients.
Doel van het onderzoek
The hypothesis is that patients with thiopurine therapy will not be at risk of impaired semen quality.
Onderzoeksopzet
Sperm quality before and during at least 3 months thiopurine therapy will be assessed.
Onderzoeksproduct en/of interventie
None
Patients will start thopurines regarding treatment of inflammatory bowel diseases
Algemeen / deelnemers
M. Simsek
Amsterdam
The Netherlands
+31 (0)20 444 07 99
m.simsek@vumc.nl
Wetenschappers
M. Simsek
Amsterdam
The Netherlands
+31 (0)20 444 07 99
m.simsek@vumc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
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Andere (mogelijk minder actuele) registraties in dit register
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL7197 |
| NTR-old | NTR7396 |
| Ander register | METC VUmc : 2017.041 |