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Search / Trial NCT05701332

Effect of Intravesical B.C.G and Gemcitabine on Semen Quality and Testicular Volume

Launched by ASSIUT UNIVERSITY · Jan 18, 2023

Trial Information

Current as of July 01, 2025

Not yet recruiting

Keywords

ClinConnect Summary

This clinical trial is looking at how two treatments, B.C.G and gemcitabine, which are given directly into the bladder, might affect men’s sperm quality and testicular size. The study focuses on men aged 20 to 60 who have been diagnosed with a type of bladder cancer that is not invasive and are planning to receive these treatments. It aims to find out if these therapies have any impact on their ability to father children.

To participate in this trial, men need to be between 20 and 60 years old and have non-invasive bladder cancer, but they should not have certain conditions that could affect their sperm count or hormone levels. Participants can expect to undergo some tests to check their semen and testicular health during the study. It's important to know that the trial is not yet recruiting participants, meaning it hasn’t started accepting volunteers yet, but it will be helpful for understanding the potential side effects of these treatments on men's reproductive health.

Gender

MALE

Eligibility criteria

  • Inclusion Criteria:
  • 1. Male patients from 20 to 60's year old (the years of reproductive active men)
  • 2. Non muscle invasive bladder (T1 or less) urothelial carcinoma who are elected to intravesical immunotherapy or chemotherapy after TURT
  • Exclusion Criteria:
  • i. T1 carcinomas of bladder in which intravesical immunotherapy and chemotherapy is contraindicated ii. Patients under conditions that may affect sperm number, e.g. Systemic chemotherapy, radiotherapy and previous history of genitourinary tuberculosis, Prostatic carcinoma,...etc iii. Abnormal semen parameters or abnormal hormonal profile (hypogonadism) that interfere with the study, especially azoospermia and aspermia

About Assiut University

Assiut University, a prominent academic institution located in Egypt, is dedicated to advancing medical research and clinical trials that enhance healthcare outcomes. With a strong emphasis on innovation and collaboration, the university engages in a wide array of clinical studies across various disciplines, aiming to contribute valuable insights into disease prevention, diagnosis, and treatment. Assiut University's commitment to ethical research practices and rigorous scientific methodology ensures the integrity and reliability of its clinical trials, ultimately benefiting both the local community and the global medical landscape.

Locations

Patients applied

0 patients applied

Trial Officials

Ahmed M Eltaher, professor

Study Director

Professor . Dr

Hosny A Behnsawy, associate professor

Study Director

Professor . Dr

Mohammed H Zarzour, lecturer

Study Director

Dr

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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