UMIN-CTR Clinical Trial

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	Obsterics 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
Email	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
Email	kazuhironanami@gmail.com

Sponsor
Institute	International University of Health and Welfare School of Medicine Department of Obstetrics and Gynecology
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042996