UMIN-CTR Clinical Trial

Basic information
Public title	The verification of safety and efficacy of ovarian tissue and oocyte cryopreservation for child patients.
Acronym	The verification of safety and efficacy of ovarian tissue and oocyte cryopreservation for child patients.
Scientific Title	The verification of safety and efficacy of ovarian tissue and oocyte cryopreservation for child patients.
Scientific Title:Acronym	The verification of safety and efficacy of ovarian tissue and oocyte cryopreservation for child patients.
Region	Japan

Condition
Condition	Leukemia, Lymphoma, rhabdomyosarcoma, Immuno deficiency, CAEBV, hematological disease, auto immune disease, collagen disease
Classification by specialty	Endocrinology and Metabolism Hematology and clinical oncology Clinical immunology Infectious disease Obsterics and gynecology Pediatrics Orthopedics
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Investigate the safety and efficacy of ovarian tissue and oocyte cryopreservation
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	safety of surgery(operation time, blood loss, complication),the numbers of ovarian cortex, the numbers of retrieved oocyte
Key secondary outcomes	The existance of minimal residual disease

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	18 years-old >
Gender	Female
Key inclusion criteria	The consalt and permission from doctor for mrimary disease, long term survive is expected, the high risk of ovarian dysfunction due to therapy for primary disease, operable condition
Key exclusion criteria	No consult and permission from primary doctor, long term survival is not expected, no gonadal risk, very poor general condition
Target sample size	50

Research contact person
Name of lead principal investigator	1st name NAO Middle name Last name SUZUKI
Organization	St. Marianna University School of Medicine
Division name	Department of Obstetrics and Gynecology
Zip code	216-8511
Address	2-16-1 Sugao, Miyamae-ku, Kawasaki city, Kanagawa
TEL	044-977-8111
Email	nao@marianna-u.ac.jp

Public contact
Name of contact person	1st name SEIDO Middle name Last name TAKAE
Organization	St. Marianna University School of Medicine
Division name	Department of Obstetrics and Gynecology
Zip code	216-8511
Address	2-16-1 Sugao, Miyamae-ku, Kawasaki city, Kanagawa, JAPAN
TEL	044-977-8111
Homepage URL
Email	s2takae@marianna-u.ac.jp

Sponsor
Institute	St. Marianna University School of Medicine
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Institutional review board of Dt. Marianna University School of Medicine
Address	2-16-1 Sugao, Miyamae-ku, Kawasaki city, Kanagawa, JAPAN
Tel	044-977-8111
Email	k-sienbu.mail@marianna-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 05 Month 30 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	2015 Year 11 Month 05 Day
Date of IRB	2015 Year 11 Month 24 Day
Anticipated trial start date	2015 Year 11 Month 24 Day
Last follow-up date	2035 Year 11 Month 24 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Now we already started the clinical research under permission of IRB.It need to observation for long period focused on the patient's condition including reproductive health.

Management information
Registered date	2020 Year 05 Month 29 Day
Last modified on	2020 Year 08 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000046311