UMIN-CTR Clinical Trial

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/icdr_e/ctr_view.cgi?recptno=R000029603