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

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

NCT ID: NCT05701332

Condition: Urothelial Carcinoma Bladder
Sperm Count, Low
Testis; Fibrosis

Conditions: Official terms:
Urinary Bladder Neoplasms
Oligospermia
Gemcitabine
BCG Vaccine

Study type: Interventional

Study phase: Phase 4

Overall status: Not yet recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Supportive Care

Masking: None (Open Label)

Intervention:

Intervention type: Biological
Intervention name: Bacillus Calmette Guerin
Description: effect of local B.C.G and Gemcitabine on semen parametes and testicular volume
Arm group label: BCG

Other name: Gemcitabine

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.

Criteria for 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

Gender: Male

Gender based: Yes

Minimum age: 20 Years

Maximum age: 60 Years

Healthy volunteers: No

Start date: April 1, 2023

Completion date: December 31, 2025

Lead sponsor:
Agency: Assiut University
Agency class: Other

Source: Assiut University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05701332