UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010828 |
|---|---|
| Receipt number | 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 18:15:03 |
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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
| Obstetrics 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)
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
kazuhironanami@gmail.com
Sponsor or person
Institute
Divison of Obstetrics and Gynecology, St. Marianna University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012674
| 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 |
