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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000010828
Receipt No. R000012674
Scientific Title Ovarian tissue freezing followed by auto-transplantation for improvement of quality of life in patients with primary ovarian insufficiency
Date of disclosure of the study information 2013/05/30
Last modified on 2014/06/03

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Basic information
Public title Ovarian tissue freezing followed by auto-transplantation for improvement of quality of life in patients with primary ovarian insufficiency
Acronym Ovarian tissue freezing followed by auto-transplantation in patients with primary ovarian insufficiency
Scientific Title Ovarian tissue freezing followed by auto-transplantation for improvement of quality of life in patients with primary ovarian insufficiency
Scientific Title:Acronym Ovarian tissue freezing followed by auto-transplantation in patients with primary ovarian insufficiency
Region
Japan

Condition
Condition primary ovarian insufficiency
Classification by specialty
Obsterics and gynecology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 1)Establishment of the safe and effective methods for ovarian tissue freezing and thawing to improve quality of life as a female in patients with primary ovarian insufficiency.

2)Establishment of effective infertility treatment by stimulating follicle growth using the methods of ovarian tissue freezing and thawing in patients with primary ovarian insufficiency.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase III

Assessment
Primary outcomes Safety and Efficacy of the ovarian tissue freezing and thawing followed by auto-transplantation into patients to improve their quality of life and infertility.
Key secondary outcomes

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Excise ovaries from the patients and freeze-thaw the ovaries. Culture thawed ovarian fragments to activate remaining follicles for 2 days and perform auto-transplantation. After grafting, monitor follicle growth for 1 year. When follicles are grown, perform in vitro fertilization and embryo transfer.
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
46 years-old >
Gender Female
Key inclusion criteria Individuals who have the ability to provide written informed consent.
Key exclusion criteria 1) Patients who can not obtain written informed consent.
2) Patients who exceed reproductive age at the time of auto-transplantation (more than or equal to 47 years)
3) Patients judged to be inappropriate for the study by the physicians.
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuhiro Kawamura
Organization St. Marianna University School of Medicine
Division name Obstetrics and Gynecology
Zip code
Address 2-16-1 Sugao Miyamaeku, Kawasaki-shi, Kanagawa, Japan
TEL 044-977-8111(ext.3332)
Email kazuhironanami@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Kazuhiro Kawamura
Organization St. Marianna University School of Medicine
Division name Obstetrics and Gynecology
Zip code
Address 2-16-1 Sugao Miyamaeku, Kawasaki-shi, Kawagawa
TEL 044-977-8111
Homepage URL
Email kazuhironanami@gmail.com

Sponsor
Institute Divison of Obstetrics and Gynecology, St. Marianna University School of Medicine
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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病院(神奈川)

Other administrative information
Date of disclosure of the study information
2013 Year 05 Month 30 Day

Related information
URL releasing protocol
Publication of results Partially published

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 Enrolling by invitation
Date of protocol fixation
2013 Year 05 Month 20 Day
Date of IRB
Anticipated trial start date
2013 Year 05 Month 20 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 05 Month 29 Day
Last modified on
2014 Year 06 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012674

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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