Clinical trial NCT05701332: Effect of Intravesical B.C.G and Gemcitabine on Semen Quality and Testicular Volume
Official title: Effect of Intravesical B.C.G and Gemcitabine on Semen Quality and Testicular Volume in Patients With Non-muscle Invasive Bladder Cancer Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Urothelial Carcinoma Bladder
Sperm Count, Low
Testis; Fibrosis
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-01-27
Enrollment: 25
Sex: MALE
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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

Primary outcomes:
measure: decrease of one or more semen parameters
timeFrame: after 3 month of the 1st semen analysis
Secondary outcomes:
measure: testicular volume
timeFrame: after 3 month of the 1st scrotal Ultrasound
Other outcomes:
Locations:
Study officials:
affiliation: Professor . Dr
name: Ahmed M Eltaher, professor
role: STUDY_DIRECTOR
affiliation: Professor . Dr
name: Hosny A Behnsawy, associate professor
role: STUDY_DIRECTOR
affiliation: Dr
name: Mohammed H Zarzour, lecturer
role: STUDY_DIRECTOR
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