Clinical trial · Interventional
Effect of Intravesical B.C.G and Gemcitabine on Semen Quality and Testicular Volume
Effect of Intravesical B.C.G and Gemcitabine on Semen Quality and Testicular Volume in Patients With Non-muscle Invasive Bladder Cancer Patients
NCT05701332CI-TRIAL-00063504unknownPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To evaluate the effects of local intravesical B.C.G and gemcitabine on semen quality and testicular volume.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Sperm Count, Low | — | UNRESOLVED | — |
| Testis; Fibrosis | — | UNRESOLVED | — |
| Urothelial Carcinoma Bladder | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bacillus Calmette Guerin | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- BCG
- description
- 6 doses of intravesical BCG
- interventionNames
- Biological: Bacillus Calmette Guerin
Primary outcomes (1)
- measure
- decrease of one or more semen parameters
- timeFrame
- after 3 month of the 1st semen analysis
- description
- 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 outcomes (1)
- measure
- testicular volume
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 20 Years
- Maximum age
- 60 Years
Show eligibility criteria text
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
References
Publications (13)
- BACKGROUNDGarg M, Sankhwar SN, Goel A, Kumar M, Singh BP, Singh V, Dalela D, Kumar A, Paul S. Effect of intravesical immunotherapy on sperm parameters in young patients with non--muscle-invasive bladder carcinoma: prospective analysis. Clin Genitourin Cancer. 2014 Jun;12(3):e83-6. doi: 10.1016/j.clgc.2013.11.012. Epub 2013 Nov 15. PMID 24411194
- BACKGROUND1. Humaid O. Al-Shamsi, Ibrahim H. Abu-Gheida, Faryal Iqbal, Aydah Al-Awadhi. Cancer in the Arab World.2022.SpringerNature. ISBN : 978-981-16-7944-5
- BACKGROUNDRaviv G, Pinthus JH, Shefi S, Mor Y, Kaufman-Francis K, Levron J, Weissenberg R, Ramon J, Madgar I. Effects of intravesical chemotherapy and immunotherapy on semen analysis. Urology. 2005 Apr;65(4):765-7. doi: 10.1016/j.urology.2004.10.049. PMID 15833524
- BACKGROUNDAvellino G, Theva D, Oates RD. Common urologic diseases in older men and their treatment: how they impact fertility. Fertil Steril. 2017 Feb;107(2):305-311. doi: 10.1016/j.fertnstert.2016.12.008. Epub 2017 Jan 7. PMID 28073432
- BACKGROUNDFlaig TW, Spiess PE, Agarwal N, Bangs R, Boorjian SA, Buyyounouski MK, Chang S, Downs TM, Efstathiou JA, Friedlander T, Greenberg RE, Guru KA, Guzzo T, Herr HW, Hoffman-Censits J, Hoimes C, Inman BA, Jimbo M, Kader AK, Lele SM, Michalski J, Montgomery JS, Nandagopal L, Pagliaro LC, Pal SK, Patterson A, Plimack ER, Pohar KS, Preston MA, Sexton WJ, Siefker-Radtke AO, Tward J, Wright JL, Gurski LA, Johnson-Chilla A. Bladder Cancer, Version 3.2020, NCCN Clinical Practice Guidelines in Oncology. J Natl Compr Canc Netw. 2020 Mar;18(3):329-354. doi: 10.6004/jnccn.2020.0011. PMID 32135513
- BACKGROUNDHan MA, Maisch P, Jung JH, Hwang JE, Narayan V, Cleves A, Hwang EC, Dahm P. Intravesical gemcitabine for non-muscle invasive bladder cancer. Cochrane Database Syst Rev. 2021 Jun 14;6(6):CD009294. doi: 10.1002/14651858.CD009294.pub3. PMID 34125951
- BACKGROUNDGriswold MD. Spermatogenesis: The Commitment to Meiosis. Physiol Rev. 2016 Jan;96(1):1-17. doi: 10.1152/physrev.00013.2015.