UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012324 |
|---|---|
| Receipt number | R000014408 |
| Scientific Title | Genetic analysis of recurrent miscarriage |
| Date of disclosure of the study information | 2013/11/18 |
| Last modified on | 2013/11/18 10:29:58 |
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Basic information
Public title
Genetic analysis of recurrent miscarriage
Acronym
Cause of recurrent miscarriage
Scientific Title
Genetic analysis of recurrent miscarriage
Scientific Title:Acronym
Cause of recurrent miscarriage
Region
| Japan |
Condition
Condition
recurrent miscarriage, recurrent pregnancy loss
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
Clinical significance of mutation of SYCP3, ANXA5, FV, FXII, PS and assay for antiphospholipid antibodies in patients with recurrent pregmamcy loss.
Basic objectives2
Others
Basic objectives -Others
significance, not treatment, but mutation or kinds of assays
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
live birth rate
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
| 20 | years-old | <= |
Age-upper limit
| 45 | years-old | >= |
Gender
Female
Key inclusion criteria
2 or more recurrent pregnancy losses
Key exclusion criteria
uterine anomaly, translocasion
Target sample size
560
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mayumi Sugiura |
Organization
Nagoya City University
Division name
Obstetrics and Gynecology
Zip code
Address
Kawasumi 1, Mizuho-ku, Nagoya
TEL
052-851-5511
og.mym@med.nagoya-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mayumi Sugiura |
Organization
Nagoya City University
Division name
Obstetrics and Gynecology
Zip code
Address
Kawasumi1, Mizuho-ku, Nagoya
TEL
052-851-5511
Homepage URL
og.mym@med.nagoya-cu.ac.jp
Sponsor or person
Institute
Nagoya City University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Hokkaido University Graduate School of Medicine
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
| 2013 | Year | 11 | Month | 18 | 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
Completed
Date of protocol fixation
| 2005 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2005 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
LA-aPTT by StaClot and aPS/PT IgG assays, but not assays for anticardiolipin IgG and M, were found to have obstetric significance.
Management information
Registered date
| 2013 | Year | 11 | Month | 18 | Day |
Last modified on
| 2013 | 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=R000014408
