The effects of THIOpurine therapy on SEMEN quality in IBD patients: a prospective cohort study

Recruiting

• Conditions: Inflammatory bowel diseases Crohn's disease Ulcerative colitisThiopurinesFertilityPaternal exposure

• Registration Number: NL-OMON23373
• Lead Sponsor: TEVA Pharmaceuticals B.V.

Brief Summary

The Association between Thiopurines and Male Fertility: a systematic review and meta-analysis

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 30

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.

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Differences in semen quality defined as sperm density, motility, morphology, ejaculation volume and total sperm count, prior to and during thiopurine exposure

Secondary Outcome Measures

Name	Time	Method
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).