UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031923 |
|---|---|
| Receipt number | R000036462 |
| Scientific Title | Study on the effects of dietary guidance on the thinning of the endometrium |
| Date of disclosure of the study information | 2018/03/27 |
| Last modified on | 2023/03/30 14:52:00 |
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Basic information
Public title
Study on the effects of dietary guidance on the thinning of the endometrium
Acronym
Study on the effects of dietary guidance on the thinning of the endometrium
Scientific Title
Study on the effects of dietary guidance on the thinning of the endometrium
Scientific Title:Acronym
Study on the effects of dietary guidance on the thinning of the endometrium
Region
| Japan |
Condition
Condition
Healthy Adults
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Study the effects of dietary guidance on the thinning of the endometrium.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Endometrial thickness
Key secondary outcomes
Presence / absence of pregnancy, equol production ability, subject background
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
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Dietary guidance
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
| Not applicable |
Gender
Female
Key inclusion criteria
1.Persons who received a sufficient explanation of the purpose and contents of the exam, have the capacity to consent, applied with free will with sufficient understanding, and agreed to participate with a written document
2.Healthy Japanese who is 20 years old or more
3.Persons who' s endometrial in the implantation stage should is less than 10 mm
4.For those with normal luteal body function (blood estradiol > 100 pg / ml, progesterone > 10 mg / ml)
Key exclusion criteria
1.Persons who have chronic illness and are receiving medication
2.Persons who have participated in other tests within the first month before the start of the test, or those who intend to participate in another exam after consenting to this exam
3.Persons who were judged as inappropriate for subjects by the principal investigator
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akihiro Sakurai |
Organization
Medical Corporation Obstetrics and gynecology clinic SACRA
Division name
President
Zip code
Address
2-9-3 Shin-ishikawa, Aoba-ku, Yokohama-shi, Kanagawa, JAPAN
TEL
045-911-9936
ceo@cl-sacra.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akihiro Sakurai |
Organization
Medical Corporation Obstetrics and gynecology clinic SACRA
Division name
President
Zip code
Address
2-9-3 Shin-ishikawa, Aoba-ku, Yokohama-shi, Kanagawa, JAPAN
TEL
045-911-9936
Homepage URL
ceo@cl-sacra.com
Sponsor or person
Institute
Healthcare Systems Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Healthcare Systems Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
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
| 2018 | Year | 03 | Month | 27 | 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
Terminated
Date of protocol fixation
| 2018 | Year | 03 | Month | 26 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 26 | Day |
Anticipated trial start date
| 2018 | Year | 03 | Month | 28 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 03 | Month | 27 | Day |
Last modified on
| 2023 | Year | 03 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036462
