A Phase 4 interventional study of Bacillus Calmette Guerin and Gemcitabine HCL (Gemzar) in Urothelial Carcinoma Bladder, Sperm Count, Low and Testis; Fibrosis, sponsored by Assiut University. Completed at 1 site in Egypt. Open to male participants aged 20 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-10-29.
Sponsored by Assiut University · Phase 4, Interventional, and Supportive care
Sahin S, Ulus I, Canitez IO, Yentur S, Temiz MZ, Semercioz A. The effect of intravesical Bacillus Calmette-Guerin (BCG) treatment on sperm parameters in non-mu…PubMed 40375148 ↗
To evaluate the effects of local intravesical B.C.G and gemcitabine on semen quality and testicular volume.
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.
64 studies on the registry are indexed under Oligospermia; 17 are open to participants now.
This study's enrollment of 86 is above the median of 65 across 46 interventional studies indexed under Oligospermia.
Browse Oligospermia studies →Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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The criteria were revised on the registry on Oct 29, 2026. See what changed
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Exclusion Criteria:
i. T1 carcinomas of bladder in which intravesical immunotherapy and chemotherapy is 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
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
6 doses of intravesical BCG
Biological: Bacillus Calmette Guerin
1 dose of Gemicitabine
Drug: Gemcitabine HCL (Gemzar)
effect of local B.C.G and Gemcitabine on semen parametes and testicular volume
Pt will receive 1dose of intravesical Gemzar
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.
Time frame: after 3 month of the 1st semen analysis
testicular volume
change in testicular volume less than 2 SD
Time frame: after 3 month of the 1st scrotal Ultrasound
Sahin S, Ulus I, Canitez IO, Yentur S, Temiz MZ, Semercioz A. The effect of intravesical Bacillus Calmette-Guerin (BCG) treatment on sperm parameters in non-mu…PubMed 40375148 ↗
Sahin S, Ulus I, Canitez IO, Yentur S, Temiz MZ, Semercioz A. The effect of intravesical Bacillus Calmette-Guerin (BCG) treatment on sperm parameters in non-mu…PubMed 40375148 ↗
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: BCG Vaccine · Gemcitabine