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

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

Detailed Description
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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.

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

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

Intervention / Treatment
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* Biological: Bacillus Calmette Guerin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male patients from 20 to 60's year old (the years of reproductive active men) 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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BCG<br>6 doses of intravesical BCG | Biological: Bacillus Calmette Guerin<br>* effect of local B.C.G and Gemcitabine on semen parametes and testicular volume<br>* Other names: Gemcitabine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| decrease of one or more semen parameters | According the 6th edition of WHO criteria of semen analysis, The main outcome is any decrease of one or more semen parameters like number of sperms less than 39 million totally, decrease in normal forms less than 4%, decrease in total motility less than 40% or progressive motility less than 30%, decrease in viability less than 54%, decrease in semen volume less than 1.5 ml. | after 3 month of the 1st semen analysis | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| testicular volume | change in testicular volume less than 2 SD | after 3 month of the 1st scrotal Ultrasound |