UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026104 |
|---|---|
| Receipt number | R000029997 |
| Scientific Title | Pilot study for ART-PGS of Japan Society of Obstetrics and Gynecology |
| Date of disclosure of the study information | 2017/06/30 |
| Last modified on | 2019/09/01 19:09:14 |
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Basic information
Public title
Pilot study for ART-PGS of Japan Society of Obstetrics and Gynecology
Acronym
Pilot study for ART-PGS of Japan Society of Obstetrics and Gynecology
Scientific Title
Pilot study for ART-PGS of Japan Society of Obstetrics and Gynecology
Scientific Title:Acronym
Pilot study for ART-PGS of Japan Society of Obstetrics and Gynecology
Region
| Japan |
Condition
Condition
repeated ART failure or repeated miscarriage during ART
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
Efficacy of PGS for repeated ART failure or repeated miscarriage during ART
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
pregnancy rate at 22th week-age of pregnancy
Key secondary outcomes
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
| 35 | years-old | <= |
Age-upper limit
| 42 | years-old | >= |
Gender
Female
Key inclusion criteria
cases during ART
Key exclusion criteria
chromosomal anomaly
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Minoru |
| Middle name | |
| Last name | Irahara |
Organization
Japan Society of Obstetrics and Gynecology
Division name
Commity for ART control
Zip code
104-0031
Address
Tokyo
TEL
03-5524-6900
rinri@jsog.or.jp
Public contact
Name of contact person
| 1st name | Rika |
| Middle name | |
| Last name | Kagoshima |
Organization
Japan Society of Obstetrics and Gynecology
Division name
Commity for ART control
Zip code
104-0031
Address
Tokyo
TEL
03-5524-6900
Homepage URL
rinri@jsog.or.jp
Sponsor or person
Institute
Japan Society of Obstetrics and Gynecology
Institute
Department
Personal name
Funding Source
Organization
self funding
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
Nagoya City University
Address
Nagoya
Tel
052-851-5511
rinri@jsog.or.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 | 06 | Month | 30 | 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
83
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
Main results already published
Date of protocol fixation
| 2016 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 12 | Month | 20 | Day |
Anticipated trial start date
| 2017 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2019 | Year | 12 | Month | 12 | Day |
Date trial data considered complete
| 2019 | Year | 12 | Month | 12 | Day |
Date analysis concluded
| 2020 | Year | 02 | Month | 01 | Day |
Other
Other related information
No
Management information
Registered date
| 2017 | Year | 02 | Month | 12 | Day |
Last modified on
| 2019 | Year | 09 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029997
| 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 |
