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

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05701332
Collaborator
(none)
25
Enrollment
1
Arm
33
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Biological: Bacillus Calmette Guerin
 Phase 4

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
25 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
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
Anticipated Study Start Date :
Apr 1, 2023
Anticipated Primary Completion Date :
Dec 1, 2025
Anticipated Study Completion Date :
Dec 31, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: BCG

6 doses of intravesical BCG

Biological: Bacillus Calmette Guerin
effect of local B.C.G and Gemcitabine on semen parametes and testicular volume
Other Names:
  • Gemcitabine

    		•

    Outcome Measures

    Primary Outcome Measures

    1. decrease of one or more semen parameters [after 3 month of the 1st semen analysis]

      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.

    Secondary Outcome Measures

    1. testicular volume [after 3 month of the 1st scrotal Ultrasound]

      change in testicular volume less than 2 SD

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 60 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    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:
    1. 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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Assiut University

    Investigators

    • Study Director: Ahmed M Eltaher, professor, Professor . Dr
    • Study Director: Hosny A Behnsawy, associate professor, Professor . Dr
    • Study Director: Mohammed H Zarzour, lecturer, Dr

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Ahmed Abdelhafeez Elsayed, Resident, Assiut University
    ClinicalTrials.gov Identifier:
    NCT05701332
    Other Study ID Numbers:
    • local drugs on semen
    First Posted:
    Jan 27, 2023
    Last Update Posted:
    Jan 27, 2023
    Last Verified:
    Jan 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Urinary Bladder Neoplasms
    Oligospermia
    Gemcitabine
    BCG Vaccine

    Study Results

    No Results Posted as of Jan 27, 2023