NCT05701332

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

Effect of Intravesical B.C.G and Gemcitabine on Semen Quality and Testicular Volume in Patients With Non-muscle Invasive Bladder Cancer Patients

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: Assiut University · Academic / Other
• Sex: Male
• Age: 20 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the effects of local intravesical B.C.G and gemcitabine on semen quality and testicular volume.

Detailed description

Local chemotherapy has become one of the alternative strategies in treatment of cancer as many side effects on organs in human body. Despite this, also local chemotherapy has adverse effects too. One of these cancers in which local chemotherapy is used and one of the most five prevalent cancers in Egyptian men and the 3rd highest incidence numbers for specific cancer cases in Egypt in 2020,also It represents the 3rd highest mortality number from cancer in Egypt by 19% of men's mortality is bladder cancer. It is divided according to the staging system into 2 main types: the non-muscle invasive (T1) and muscle invasive (T2).The most common method used to treat T1 baldder cancer are TURT followed by local intravesical immunotherapy (like Bacillus Calmette Guerin) and chemotherapy (Gemcitabine and Mitomycin C). These drugs systemically can cause side effects like urgency, frequency, low grade fever, malaise, effect on high proliferative tissues like bone marrow, skin, hair, and seminiferous tubules….etc. Some rare side effects are acute respiratory distress syndrome and hepatic toxicity. The effect of these drugs on seminiferous tubules is still a controversy as most of the research field is focusing on systemic use, also the lack of researches focusing on local intravesical use. It can cause infertility especially in young patients with cancer who seek fertility and they are not married or not having children. The problem of fertility and urogenital cancer is multifactorial and there is a gap of knowledge as low incidence number of bladder cancer in young patients and the lack of he studies focusing on fertility in cancer patients. This study is going to unmask the mystery of one of local immunotherapy and immunotherapy and there effect on semen and testicles.

Conditions

• Urothelial Carcinoma Bladder
• Sperm Count, Low
• Testis; Fibrosis

Interventions

Type	Name	Description
BIOLOGICAL	Bacillus Calmette Guerin	effect of local B.C.G and Gemcitabine on semen parametes and testicular volume

Timeline

• Start date: 2023-04-01
• Primary completion: 2025-12-01
• Completion: 2025-12-31
• First posted: 2023-01-27
• Last updated: 2023-01-27