No registrations found.
ID
Source
Brief title
Health condition
Inflammatory bowel diseases
Crohn's disease
Ulcerative colitis
Thiopurines
Fertility
Paternal exposure
Sponsors and support
Intervention
Outcome measures
Primary outcome
Differences in semen quality defined as sperm density, motility, morphology, ejaculation volume and total sperm count, prior to and during thiopurine exposure
Secondary outcome
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).
Background summary
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.
Study objective
The hypothesis is that patients with thiopurine therapy will not be at risk of impaired semen quality.
Study design
Sperm quality before and during at least 3 months thiopurine therapy will be assessed.
Intervention
None
Patients will start thopurines regarding treatment of inflammatory bowel diseases
M. Simsek
Amsterdam
The Netherlands
+31 (0)20 444 07 99
m.simsek@vumc.nl
M. Simsek
Amsterdam
The Netherlands
+31 (0)20 444 07 99
m.simsek@vumc.nl
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
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
Recruitment
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 | NL7197 |
| NTR-old | NTR7396 |
| Other | METC VUmc : 2017.041 |