UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047678 |
|---|---|
| Receipt number | R000054362 |
| Scientific Title | Development of a new ART technology utilizing cytoplasmic transfer/replacement |
| Date of disclosure of the study information | 2022/06/01 |
| Last modified on | 2024/11/18 17:00:10 |
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Basic information
Public title
Development of a new ART technology utilizing cytoplasmic transfer/replacement
Acronym
Application of MRT in ART
Scientific Title
Development of a new ART technology utilizing cytoplasmic transfer/replacement
Scientific Title:Acronym
Application of MRT in ART
Region
| Japan |
Condition
Condition
Infertile couples undergoing ICSI
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study is to utilize cytoplasmic transfer/replacement techniques, in which developed to prevent transmission of inherited mitochondrial diseases, for overcoming of cytoplasmic function or for creating of a new fertilizable egg in ART. Recently, preserving of their future fertility for AYA generation of young cancer patient being standard practice. However, issues that the cryo-damage on eggs or a limit on the number of treatments is determined by the number of originally cryopreserved eggs, are unsolved. Number and quality of eggs in advanced age infertility patient is also critical. Aim of this study is to verify utilization of cytoplasmic transfer/replacement techniques for overcoming those problems of the cytoplasmic quality and a number of eggs for fertility treatment.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Feasibility of utilization of female genome in 1st polar body of freeze-thaw human eggs in ART by combination of polar body transfer/maternal spindle transfer techniques.
Key secondary outcomes
In vitro development of parthenogenetically activated embryos, ATP and respiratory measurement on developed blastocyst, Spindle morphology and expression of functional proteins.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 42 | years-old | >= |
Gender
Female
Key inclusion criteria
Infertility,Both primary and secondary.
No matter what the cause of infertility
Age between 20 to 42 is eligible
Gender: female who has immature egg
Key exclusion criteria
Patient who has infections, such as hepatitis B and C, syphilis, HIV and other virus carrier.
Patient who has been registered in other clinical trial
In case doctor in charge decided inappropriate.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Masahito |
| Middle name | |
| Last name | Tachibana |
Organization
Tohoku university graduate school of medicine
Division name
Dept of perinatology
Zip code
9808574
Address
1-1 Seiryomachi, Aoba-ward, Sendai, Miyagi, 980-8574 Japan
TEL
0227177254
masahito.tachibana.c1@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Masahito |
| Middle name | |
| Last name | Tachibana |
Organization
Tohoku university graduate school of medicine
Division name
Dept of perinatology
Zip code
9808574
Address
1-1 Seiryomachi, Aoba-ward, Sendai, Miyagi, 980-8574 Japan
TEL
0227177254
Homepage URL
masahito.tachibana.c1@tohoku.ac.jp
Sponsor or person
Institute
Tohoku university graduate school of medicine
Institute
Department
Personal name
Funding Source
Organization
JSPS KAKENHI
Grants-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee Tohoku University Graduate School of Medicine
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8575, Japan
Tel
022-717-8007
med-kenkyo@grp.tohoku.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
2022
Org. issuing International ID_1
Ethics Committee Tohoku University Graduate School of Medicine
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 06 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
45
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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 05 | Month | 06 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 13 | Day |
Anticipated trial start date
| 2022 | Year | 06 | Month | 30 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2022 | Year | 05 | Month | 08 | Day |
Last modified on
| 2024 | Year | 11 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054362
