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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000025735
Receipt No. R000029603
Scientific Title Cryo-preservation and auto-transplantation of ovarin tissues in primary ovarian insufficient patients.
Date of disclosure of the study information 2017/01/19
Last modified on 2019/07/29

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Basic information
Public title Cryo-preservation and auto-transplantation of ovarin tissues in primary ovarian insufficient patients.
Acronym in vitro activaton of ovarian follicle
Scientific Title Cryo-preservation and auto-transplantation of ovarin tissues in primary ovarian insufficient patients.
Scientific Title:Acronym in vitro activaton of ovarian follicle
Region
Japan

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

Objectives
Narrative objectives1 Establishment of the safety and effective methods for ovarian cryo-preservation and thawing to improve quality of life in POI patients.

Establishment of effective infertility treatment by stimulating ovarian follicle growth.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Safety and efficacy of the ovarian tissue cryo-preservation 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 Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Excise ovary from the patients and freeze-thaw the ovary. Culture thawed ovarian fragments to activate follicles for 2 days and perform auto-transplantation. After grafting, follicle growth will be monitored for 1 year. When ovarian 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
20 years-old <=
Age-upper limit

Not applicable
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 informe consent.
2. Patients who exceed reproductive age at the time of auto-transplantation. (more than or equal to 47 years old.)
3. Patients judged to be inappropriate for the study by the physicians.
Target sample size 150

Research contact person
Name of lead principal investigator
1st name Akitoshi
Middle name
Last name Nakashima
Organization The University of Toyama
Division name Obstetrics and Gynecology
Zip code 930-0194
Address 2630 Sugitani Toyama-shi Toyama, Japan
TEL 076-434-7357
Email akinaka@med.u-toyama.ac.jp

Public contact
Name of contact person
1st name Masami
Middle name
Last name Ito
Organization The University of Toyama
Division name Obstetrics and Gynecology
Zip code 930-0194
Address 2630 Sugitani Toyama-shi Toyama, Japan
TEL 076-434-7357
Homepage URL http://www.hosp.u-toyama.ac.jp/guide/news/news170131.html
Email obgyn@med.u-toyama.ac.jp

Sponsor
Institute Division of Obstetrics and Gynecolgy, The University of Toyama
Institute
Department

Funding Source
Organization self-procuranc
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor St. Mother Hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization Clinical research management center of Toyama University
Address 2630 Sugitani Toyama-shi Toyama, Japan
Tel 076-434-7154
Email y07125@med.u-toyama.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
2017 Year 01 Month 19 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
2017 Year 01 Month 01 Day
Date of IRB
2019 Year 07 Month 10 Day
Anticipated trial start date
2017 Year 02 Month 01 Day
Last follow-up date
2021 Year 07 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
2017 Year 01 Month 19 Day
Last modified on
2019 Year 07 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029603

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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