UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025735 |
|---|---|
| Receipt number | 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 11:10:13 |
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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
| Obstetrics 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
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
obgyn@med.u-toyama.ac.jp
Sponsor or person
Institute
Division of Obstetrics and Gynecolgy, The University of Toyama
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029603
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
