UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037701 |
|---|---|
| Receipt number | R000042996 |
| Scientific Title | Establishment of in vitro testicular tissue cultuure |
| Date of disclosure of the study information | 2019/08/16 |
| Last modified on | 2019/08/16 11:45:17 |
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Basic information
Public title
Establishment of in vitro testicular tissue cultuure
Acronym
In vitro testicular tissue culture
Scientific Title
Establishment of in vitro testicular tissue cultuure
Scientific Title:Acronym
In vitro testicular tissue culture
Region
| Japan |
Condition
Condition
azoospermia
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, we attempt to develop a new method to be able to induce differentiation of gem cells into sperm by in vitro culture of human testicular tissue in patients with non-obstructive azoospermia (NOA).
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
We perform different methods of in vitro culture of human testicular tissue up to 75 days. After culture, we examine the formation of sperm by histological and molecular analyses.
Key secondary outcomes
We evaluate the normality of different developmental stages of germ line cells by morphological and molecular analyses. Also, we explore the causes of spermatogenesis dysfunction using molecular approaches.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
We perform in vitro culture of human testicular tissue up to 75 days.
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
1. Azoospermia
2. Severe oligospermia
Above 1 or 2 patients who receive testicular sperm extraction (TESE) treatment.
Key exclusion criteria
1. Patients who can not obtain agreement to participate this study.
2. Patients who judged to be inappropriate for this study by attending doctors.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Kawamura |
Organization
International University Health and Welfare School of Medicine
Division name
Department of Obstetrics and Gynecology
Zip code
286-0048
Address
4-3 Koudunomori,Narita-shi,Chiba
TEL
0476-20-7701
kazuhironanami@gmail.com
Public contact
Name of contact person
| 1st name | Kazhuhiro |
| Middle name | |
| Last name | Kawamura |
Organization
International University Health and Welfare School of Medicine
Division name
Department of Obstetrics and Gynecology
Zip code
286-0048
Address
4-3 Koudunomori,Narita-shi,Chiba
TEL
0476-20-7701
Homepage URL
kazuhironanami@gmail.com
Sponsor or person
Institute
International University of Health and Welfare School of Medicine
Department of Obstetrics and Gynecology
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japam
Other related organizations
Co-sponsor
Sanno Hospital, St. Mother Obstetrics and gynecology clinic
Name of secondary funder(s)
IRB Contact (For public release)
Organization
International University Health and Welfare School of Medicine
Address
4-3 Koudunomori,Narita-shi,Chiba
Tel
0476-20-7701
rinri_md@iuhw.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
| 2019 | Year | 08 | Month | 16 | 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
Open public recruiting
Date of protocol fixation
| 2018 | Year | 10 | Month | 29 | Day |
Date of IRB
| 2018 | Year | 10 | Month | 29 | Day |
Anticipated trial start date
| 2019 | Year | 08 | Month | 16 | Day |
Last follow-up date
| 2021 | 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
| 2019 | Year | 08 | Month | 16 | Day |
Last modified on
| 2019 | Year | 08 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042996
