UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018955 |
|---|---|
| Receipt number | R000021895 |
| Scientific Title | Clinical study on preimplantation genetic diagnosis |
| Date of disclosure of the study information | 2015/10/01 |
| Last modified on | 2015/09/09 18:13:00 |
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Basic information
Public title
Clinical study on preimplantation genetic diagnosis
Acronym
Clinical study on PGD
Scientific Title
Clinical study on preimplantation genetic diagnosis
Scientific Title:Acronym
Clinical study on PGD
Region
| Japan |
Condition
Condition
Serious inherited diseases and recurrent pregnancy loss due to structural chromosomal abnormalities
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To validate the diagnostic accuracy of PGD and to accumulate the results including the prognosis of the newborn baby
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
diagnostic accuracy
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
Diagnosis
Type of intervention
| Gene | Maneuver |
Interventions/Control_1
preimplantation genetic diagnosis
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
It is applied as a general rule only when the client carry the mutatation in the responsible gene that may lead a delivery of a child affected by serious hereditary diseases and chromosomal aberration
Key exclusion criteria
nothing paticulary
Target sample size
1
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kou Sueoka |
Organization
Keio University School of Medicine
Division name
Department of Obstetrics and Gynecology
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-3353-1211
ksueoka@keio.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Suguru Sato |
Organization
Keio University School of Medicine
Division name
Department of Obstetrics and Gynecology
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-3353-1211
Homepage URL
sugurusato@keio.jp
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 10 | 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
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
Open public recruiting
Date of protocol fixation
| 2015 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 09 | Month | 07 | 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
| 2015 | Year | 09 | Month | 09 | Day |
Last modified on
| 2015 | Year | 09 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021895
