UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015298 |
|---|---|
| Receipt number | R000017737 |
| Scientific Title | Evaluation of mean endometrial thickness in Japanese women |
| Date of disclosure of the study information | 2014/10/01 |
| Last modified on | 2018/10/03 20:53:38 |
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Basic information
Public title
Evaluation of mean endometrial thickness in Japanese women
Acronym
MET study
Scientific Title
Evaluation of mean endometrial thickness in Japanese women
Scientific Title:Acronym
MET study
Region
| Japan |
Condition
Condition
endometrial cancer
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the mean endometrial thickness in healthy Japanese women using transvaginal ultrasonography
Basic objectives2
Others
Basic objectives -Others
Other
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
mean endometrial thickness
Key secondary outcomes
Relationship between mean endometrial thickness and clinical factor (symptoms, risk factor of endometrial cancer, examinee's place of residence)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Measure the endometrial thickness by transvaginal ultorasonography
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
Female
Key inclusion criteria
Persons who visit the clinic of office genecology, without endometrial disease
Key exclusion criteria
1) Persons receiving the medicine which have an effect on the endometrial thickness such like hormone therapy or tamoxifen
2) Persons who have a difficulty in measuring the endometrial thickness because of clinical factor such like myoma uteri or adenomyosis
3) Persons with endometrial polyp
4) Persons with endometrial cancer or endometrial hyperplasia
5) Persons receiving medicine for sterility
6) Users of foods or supplement which might affect the endometrial thickness (placenta etc)
7) Persons who have been judged to be inappropriate for the study by a researcher
Target sample size
1250
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Tsuda |
Organization
Mizuho Women's Clinic
Division name
Obstetrics and Gynecology
Zip code
Address
2-10-9, Honcho, Kokubunji City Tokyo Japan
TEL
0423000011
htsud@mizuho-wcl.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi Tsuda |
Organization
Mizuho Women's Clinic
Division name
Obstetrics and Gynecology
Zip code
Address
2-10-9, Honcho, Kokubunji City Tokyo Japan
TEL
0423000011
Homepage URL
htsud@mizuho-wcl.com
Sponsor or person
Institute
Mizuho Women's Clinic
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
| 2014 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
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
Completed
Date of protocol fixation
| 2014 | Year | 09 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2015 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2015 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2016 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 09 | Month | 30 | Day |
Last modified on
| 2018 | Year | 10 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017737
