NCT05701332

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Apr 2023

Typical duration for phase_4

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 18, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 27, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2023

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

January 27, 2023

Status Verified

January 1, 2023

Enrollment Period

2.7 years

First QC Date

January 18, 2023

Last Update Submit

January 18, 2023

Conditions

Urothelial Carcinoma BladderSperm Count, LowTestis; Fibrosis

Outcome Measures

Primary Outcomes (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.

    after 3 month of the 1st semen analysis

Secondary Outcomes (1)

  • testicular volume

    after 3 month of the 1st scrotal Ultrasound

Study Arms (1)

BCG

EXPERIMENTAL

6 doses of intravesical BCG

Biological: Bacillus Calmette Guerin

Interventions

Bacillus Calmette GuerinBIOLOGICAL

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

Also known as: Gemcitabine
BCG

Eligibility Criteria

Age20 Years - 60 Years
Sexmale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (13)

  • 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.

    PMID: 24411194BACKGROUND

  • 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

    BACKGROUND

  • 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.

    PMID: 15833524BACKGROUND

  • 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.

    PMID: 28073432BACKGROUND

  • 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.

    PMID: 32135513BACKGROUND

  • 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.

    PMID: 34125951BACKGROUND

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

    PMID: 26537427BACKGROUND

  • 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.

    PMID: 18497337BACKGROUND

  • 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.

    PMID: 6629684BACKGROUND

  • 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.

    PMID: 27283219BACKGROUND

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

    BACKGROUND

  • 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.

    PMID: 34947899BACKGROUND

  • 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.

    PMID: 28326513BACKGROUND

MeSH Terms

Conditions

OligospermiaFibrosis

Interventions

BCG VaccineGemcitabine

Condition Hierarchy (Ancestors)

Infertility, MaleGenital Diseases, MaleGenital DiseasesUrogenital DiseasesInfertilityMale Urogenital DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tuberculosis VaccinesBacterial VaccinesVaccinesBiological ProductsComplex MixturesHeterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Ahmed M Eltaher, professor

    Professor . Dr

    STUDY DIRECTOR

  • Hosny A Behnsawy, associate professor

    Professor . Dr

    STUDY DIRECTOR

  • Mohammed H Zarzour, lecturer

    Dr

    STUDY DIRECTOR

Central Study Contacts

Ahmed A Elsayed, resident

CONTACT

+2 01065973921ahmed.14223921@med.aun.edu.eg

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident

Study Record Dates

First Submitted

January 18, 2023

First Posted

January 27, 2023

Study Start

April 1, 2023

Primary Completion

December 1, 2025

Study Completion

December 31, 2025

Last Updated

January 27, 2023

Record last verified: 2023-01