AzTrials
AzTrials

Urothelial Carcinoma BladderPhase 4NCT05701332

Effect of Intravesical B.C.G and Gemcitabine on Semen Analysis and Testicular Volume in NMIBC

A Phase 4 study testing Bacillus Calmette Guerin and Gemcitabine HCL (Gemzar) in people with Urothelial Carcinoma Bladder and Sperm Count, Low, run by Assiut University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

To evaluate the effects of local intravesical B.C.G and gemcitabine on semen quality and testicular volume. Read more about this study

Who is it for?
Ages 20 to 70 years, men only
What is being tested?
Bacillus Calmette Guerin and Gemcitabine HCL (Gemzar)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
86 participants
Where
1 siteEgypt
Study dates
1 Apr 2023to 18 Jan 2025
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 70 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male patients from 20 to 70'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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • Faculty of Medicine Assiut University

    Asyut

Other trials in Egypt

About this study

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

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

Read the 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.

Being tested
Bacillus Calmette Guerin, Gemcitabine HCL (Gemzar)
Medical subject headings
Oligospermia, Fibrosis, Non-Muscle Invasive Bladder Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bacillus Calmette GuerinBiological

    effect of local B.C.G and Gemcitabine on semen parametes and testicular volume

  • Gemcitabine HCL (Gemzar)Drug

    Pt will receive 1dose of intravesical Gemzar

Study groups in NCT05701332
Study groupRoleWhat they receive
BCGActive comparator6 doses of intravesical BCG
Receives: Biological: Bacillus Calmette Guerin
GemcitabineActive comparator1 dose of Gemicitabine
Receives: Drug: Gemcitabine HCL (Gemzar)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: after 3 month of the 1st semen analysis

Secondary outcomes (1)

  1. testicular volume

    change in testicular volume less than 2 SD

    Measured: after 3 month of the 1st scrotal Ultrasound

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2023
  2. Study start1 Apr 2023
  3. Primary completion18 Jan 2025
  4. Study completion18 Jan 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Supportive care
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
86 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05701332
Sponsor's protocol ID
local drugs on semen&testes
Status last verified
Jan 2023
First submitted
18 Jan 2023
Last updated
29 Oct 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Garg 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.

    PubMed 24411194

  • 1. 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

  • Raviv 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.

    PubMed 15833524

  • Avellino 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.

    PubMed 28073432

  • Flaig 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.

    PubMed 32135513

  • Han 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.

    PubMed 34125951

  • Griswold MD. Spermatogenesis: The Commitment to Meiosis. Physiol Rev. 2016 Jan;96(1):1-17. doi: 10.1152/physrev.00013.2015.

    PubMed 26537427

  • Amann RP. The cycle of the seminiferous epithelium in humans: a need to revisit? J Androl. 2008 Sep-Oct;29(5):469-87. doi: 10.2164/jandrol.107.004655. Epub 2008 May 22.

    PubMed 18497337

  • Frick J, Kunit G, Joos H, Rovan E, Talwar GP. Effect of intratesticular administration of BCG on testicular function (preliminary report). Int Urol Nephrol. 1983;15(1):71-81. doi: 10.1007/BF02082110.

    PubMed 6629684

  • Polland A, Berookhim BM. Fertility concerns in men with genitourinary malignancies: Treatment dilemmas, fertility options, and medicolegal considerations. Urol Oncol. 2016 Sep;34(9):399-406. doi: 10.1016/j.urolonc.2016.05.007. Epub 2016 Jun 6.

    PubMed 27283219

  • Mulhall JP, Applegarth LD, Oates RD, Schlegel PN. Fertility Preservation in Male Cancer Patients: Cambridge University Press; 2013.

  • Boitrelle F, Shah R, Saleh R, Henkel R, Kandil H, Chung E, Vogiatzi P, Zini A, Arafa M, Agarwal A. The Sixth Edition of the WHO Manual for Human Semen Analysis: A Critical Review and SWOT Analysis. Life (Basel). 2021 Dec 9;11(12):1368. doi: 10.3390/life11121368.

    PubMed 34947899

  • Talarczyk-Desole J, Berger A, Taszarek-Hauke G, Hauke J, Pawelczyk L, Jedrzejczak P. Manual vs. computer-assisted sperm analysis: can CASA replace manual assessment of human semen in clinical practice? Ginekol Pol. 2017;88(2):56-60. doi: 10.5603/GP.a2017.0012.

    PubMed 28326513

  • 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-muscle-invasive bladder cancer patients. Basic Clin Androl. 2025 May 15;35(1):17. doi: 10.1186/s12610-025-00259-0.

    PubMed 40375148

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Bacillus Calmette Guerin and Gemcitabine HCL (Gemzar) in people with Urothelial Carcinoma Bladder and Sperm Count, Low, run by Assiut University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

decrease of one or more semen parameters (time frame: after 3 month of the 1st semen analysis). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05701332, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in