UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Genetical analysis of extra X in Klinefelter Syndrome: 47XXY
Title of the study (Brief title)	Cytogenetical analysis of chromosomal abnormality of Klinefelter Syndrome
Region	Japan

Condition
Condition	Klinefelter Syndrome
Classification by specialty	Obsterics and gynecology
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	To verify the actual risk of hereditary Klinefelter Syndrome (KS) or incidental aneuploidy in ICSI treatment of KS patients, which has been warned in previous cytogenetic studies using testicular cells from KS patients.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	12X-STR (short tandem repeat) in KS patients and their parents to investigate the origin of the extra X.
Key secondary outcomes	Physical and cognitive development of KS patient's babies.

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	Educational,Counseling,Training
Type of intervention	Other
Interventions/Control_1	We investigated the origin of the extra-X using X chromosome haplotype markers, 12X-STR (short tandem repeat) in 11 KS patients and their parents who had consented to participate in this study.
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	KS patients and their parents who had consented to participate in this study.
Key exclusion criteria	In the case when informed consent could not be obtained from patients or their parents.
Target sample size	30

Research contact person
Name of lead principal investigator	Atsushi Tanaka
Organization	Saint Mother Hospital
Division name	Obstetrics and Gynecology
Address	4-9-12, Orio Yahatanishi, Kitakyusyu, Fukuoka, JAPAN
TEL	093-601-2000
Email	incho@stmother.com

Public contact
Name of contact person	Atsushi Tanaka
Organization	Saint Mother Hospital
Division name	Obstetrics and Gynecology
Address	4-9-12, Orio Yahatanishi, Kitakyusyu, Fukuoka, JAPAN
TEL	093-601-2000
Homepage URL
Email	incho@stmother.com

Sponsor
Institute	Saint Mother Hospital
Institute
Department

Funding Source
Organization	Saint Mother Hospital
Organization
Division
Category of Funding Organization	Self funding
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

Other administrative information
Date of disclosure of the study information	2016 Year 10 Month 24 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2016 Year 10 Month 06 Day
Anticipated trial start date	2016 Year 10 Month 24 Day
Last follow-up date
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	2016 Year 10 Month 24 Day
Last modified on	2016 Year 10 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028136