UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041473 |
|---|---|
| Receipt number | R000039022 |
| Scientific Title | Sperm cryopreservation for fertility-preservation in young male cancer patients, hematopoietic cell transplantation recipients and immune disease patients |
| Date of disclosure of the study information | 2020/08/20 |
| Last modified on | 2020/08/20 13:18:14 |
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Basic information
Public title
Sperm cryopreservation for fertility-preservation in young male cancer patients, hematopoietic cell transplantation recipients and immune disease patients
Acronym
Sperm cryopreservation for fertility-preservation
Scientific Title
Sperm cryopreservation for fertility-preservation in young male cancer patients, hematopoietic cell transplantation recipients and immune disease patients
Scientific Title:Acronym
Sperm cryopreservation for fertility-preservation
Region
| Japan |
Condition
Condition
Cancer patient including hematological malignancy, autoimmune disease such as SLE
Classification by specialty
| Medicine in general | Gastroenterology | Hepato-biliary-pancreatic medicine |
| Pneumology | Endocrinology and Metabolism | Hematology and clinical oncology |
| Nephrology | Clinical immunology | Gastrointestinal surgery |
| Hepato-biliary-pancreatic surgery | Chest surgery | Endocrine surgery |
| Breast surgery | Obstetrics and Gynecology | Pediatrics |
| Orthopedics | Urology | Neurosurgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Verification of the effectiveness and safety in sperm cryopreservation as a clinical study for a fertility-preservation
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sperm count and motility (before and after cryopreservation)
Key secondary outcomes
Fertilization rate, Live birth rate
Influence of primary disease, treatment, patient's age and complications on sperm reserve and endocrine function after treatment
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
sperm collection (ejaculated sperm) for cryopreservation
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
Patients at risk of impairment of spermatogenesis due to treatment for cancer or immune disease.
Expected long-term survival
After puberty
Key exclusion criteria
Patients who do not agree to participate in this study
Patients whom the start of therapy delays due to this study
Patients who are judged to be ineligible for this study
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Masaki |
| Middle name | |
| Last name | Mandai |
Organization
Graduate school of medicine, Kyoto University
Division name
Department of obstetrics and gynecology
Zip code
606-8507
Address
Kawaharacho 54, Sho-goin, Sakyo-ku, Kyoto
TEL
075-751-3269
mandai@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Akihito |
| Middle name | |
| Last name | Horie |
Organization
Graduate school of medicine, Kyoto University
Division name
Department of obstetrics and gynecology
Zip code
606-8507
Address
Kawaharacho 54, Sho-goin, Sakyo-ku, Kyoto
TEL
075-751-3269
Homepage URL
a_horie@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
Yoshida-Konoe-cho, Sakyo-ku, Kyoto
Tel
075-753-4680
ethcom@kuhp.kyoto-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
| 2020 | Year | 08 | 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
Enrolling by invitation
Date of protocol fixation
| 2018 | Year | 09 | Month | 21 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 18 | Day |
Anticipated trial start date
| 2019 | Year | 03 | Month | 18 | Day |
Last follow-up date
| 2034 | Year | 03 | Month | 18 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 08 | Month | 20 | Day |
Last modified on
| 2020 | Year | 08 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039022
