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

Email

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


Email

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


Email



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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name