UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Establishment of external culture of testicular tissue
Title of the study (Brief title)	Establishment of external culture of testicular tissue
Region	Japan

Condition
Condition	Azoospermia
Classification by specialty	Obsterics and gynecology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Establishment of new sperm acquisition method for patients who can not obtain sperm by testicular sperm collection method and have to abandon infertility therapy.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase I

Assessment
Primary outcomes	To elucidate spermatogenesis induction andits molecular mechanism.
Key secondary outcomes	Functional analysis of sperm acquired and verification of normality

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification	NO
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	1)Extra testicular tissue is collected from a patient who underwent the testicular sperm collection method for azoospermia. 2)Carry out boundary culture of gas phase liquid layer. 3)The presence or absence of spermatogenesis is examined by histological, molecular biological analysis.
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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male
Key inclusion criteria	Azoospermia
Key exclusion criteria	Patient who the doctor in charge judged inappropriate as the subject of this study
Target sample size	20

Research contact person
Name of lead principal investigator	Nobuhito Yoshioka
Organization	St Marianna university school of Medicine
Division name	Obstetrics and gynecology
Address	2-16-1 Sugao Miyamae Kawasaki Kanagawa
TEL	0449778111
Email	n3yoshioka@marianna-u.ac.jp

Public contact
Name of contact person	Nobuhito Yoshioka
Organization	St Marianna university school of Medicine
Division name	Obstetrics and gynecology
Address	2-16-1 Sugao Miyamae Kawasaki Kanagawa
TEL	0449778111
Homepage URL
Email	n3yoshioka@marianna-u.ac.jp

Sponsor
Institute	St Marianna university school of Medicine
Institute
Department

Funding Source
Organization	St Marianna university school of Medicine
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	聖マリアンナ医科大学

Other administrative information
Date of disclosure of the study information	2017 Year 04 Month 01 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2015 Year 07 Month 06 Day
Anticipated trial start date	2015 Year 07 Month 10 Day
Last follow-up date	2018 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 02 Month 20 Day
Last modified on	2017 Year 02 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030070