UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060678 |
|---|---|
| Receipt number | R000069405 |
| Scientific Title | Cryopreservation of Testicular Tissue in Pediatric Cancer Patients |
| Date of disclosure of the study information | 2026/02/20 |
| Last modified on | 2026/02/15 17:29:27 |
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Basic information
Public title
Cryopreservation of Testicular Tissue in Pediatric Cancer Patients
Acronym
Cryopreservation of Testicular Tissue in Pediatric Cancer Patients
Scientific Title
Cryopreservation of Testicular Tissue in Pediatric Cancer Patients
Scientific Title:Acronym
Cryopreservation of Testicular Tissue in Pediatric Cancer Patients
Region
| Japan |
Condition
Condition
Pediatric Cancer
Classification by specialty
| Pediatrics | Urology | Child |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to harvest and cryopreserve testicular tissue prior to cancer treatment in pediatric cancer patients who are expected to receive gonadotoxic therapies that may result in male infertility.
Basic objectives2
Others
Basic objectives -Others
Cancer treatments such as chemotherapy and radiotherapy can impair spermatogenesis and lead to future male infertility. While postpubertal male patients can preserve fertility through sperm cryopreservation prior to treatment, no established method currently exists for prepubertal boys because mature spermatozoa are absent. Recent advances in reproductive research have demonstrated in animal models that sperm can be derived from immature testicular tissue. This study aims to harvest and cryopreserve testicular tissue from pediatric male cancer patients prior to treatment in order to preserve the potential for future fertility and to contribute to the advancement of basic reproductive research necessary for future clinical application.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Success rate of testicular tissue harvesting and cryopreservation
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Orchiectomy or partial orchiectomy will be performed under general anesthesia.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male
Key inclusion criteria
Male patients scheduled to undergo cancer treatment that may impair spermatogenesis.
Male patients from birth to prepubertal stage with bilaterally descended testes.
Male patients with sufficient testicular volume to allow tissue harvesting.
Male patients deemed fit to undergo general anesthesia and orchiectomy or partial orchiectomy, as determined by the Department of Anesthesiology.
Male patients for whom the primary treating department has reviewed the potential impact of study participation on treatment of the underlying disease and has approved participation in this study.
Male patients for whom written informed consent has been obtained.
Male patients considered appropriate for participation by the principal investigator or sub-investigators.
Key exclusion criteria
Male patients without bilaterally descended testes.
Male patients with known testicular abnormalities.
Male patients with insufficient testicular volume for tissue harvesting.
Male patients capable of ejaculation.
Male patients in whom spermatozoa are present in the testes.
Male patients deemed unfit to undergo general anesthesia and orchiectomy or partial orchiectomy.
Male patients considered inappropriate for anesthesia by the Department of Anesthesiology.
Male patients for whom participation in this study is considered to have a significant negative impact on treatment of the underlying disease and is not approved by the primary treating department.
Male patients for whom written informed consent cannot be obtained.
Male patients considered inappropriate for participation by the principal investigator or sub-investigators.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yasuji |
| Middle name | |
| Last name | Kitabatake |
Organization
The University of Osaka Graduate School of Medicine
Division name
Department of Pediatrics
Zip code
565-0871
Address
2-15 Yamadaoka, Suita, Osaka, Japan
TEL
06-6879-5111
ykitaba@ped.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Kentaro |
| Middle name | |
| Last name | Takezawa |
Organization
The University of Osaka Graduate School of Medicine
Division name
Department of Urology
Zip code
565-0871
Address
2-2 Yamadaoka, Suita, Osaka, Japan
TEL
06-6879-3531
Homepage URL
takezawa@uro.med.osaka-u.ac.jp
Sponsor or person
Institute
The University of Osaka
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Reserch and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Review Committee, The University of Osaka Graduate School of Medicine / Osaka University Hospital
Address
2-2 Yamadaoka, Suita, Osaka, Japan
Tel
06-6210-8296
rin-sokatu@dmi.med.osaka-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 02 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2026 | Year | 02 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 03 | Month | 20 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 02 | Month | 15 | Day |
Last modified on
| 2026 | Year | 02 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069405
