UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051792 |
|---|---|
| Receipt number | R000059104 |
| Scientific Title | Examining the effectiveness of a check sheet-style method where early disease detection and diagnostic is made possible for infertility prevention |
| Date of disclosure of the study information | 2023/08/02 |
| Last modified on | 2023/08/02 12:35:57 |
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Basic information
Public title
Examining the effectiveness of a check sheet-style method where early disease detection and diagnostic is made possible for infertility prevention
Acronym
Examining the effectiveness of a check sheet-style method where early disease detection and diagnostic is made possible for infertility prevention
Scientific Title
Examining the effectiveness of a check sheet-style method where early disease detection and diagnostic is made possible for infertility prevention
Scientific Title:Acronym
Examining the effectiveness of a check sheet-style method where early disease detection and diagnostic is made possible for infertility prevention
Region
| Japan |
Condition
Condition
menstrual disorder ( dysmenorrhea, endometriosis, pcos), POI
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Providing a simple check sheet where an average woman can detect/diagnose menstrual disorders and/or POI at an early stage.
Basic objectives2
Others
Basic objectives -Others
To verify the effectiveness of the self check sheet itself in detecting and providing an early diagnosis for infertility causing diseases.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Diagnostic rate of menstrual disorders and POI
Key secondary outcomes
1. Transvaginal Ultrasound
2. Hemoglobin, AMH
3. TSH, T3, T4, PRL, LH, FSH, E2, Testosterone
Additional answers provided by the check sheet
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Subjects which exceed the threshold of "needs medical attention" on the check sheet will be examined and tested.
Interventions/Control_2
Subjects who remain as "healthy" on the check sheet will also be examined and tested for control.
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
| 42 | years-old | >= |
Gender
Female
Key inclusion criteria
Ages over 20 and under 43
Have signed the consent form.
Equal numbers of subjects selected from the "needs medical attention" group and "healthy" group determined through the check sheet.
Key exclusion criteria
Subjects deemed ineligible as study participants by the research director
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Kawamura |
Organization
Juntendo University Faculty of Medicine
Division name
Departments of Obstetrics and Gynecology
Zip code
113-8421
Address
2-1-1, Hongo, Bunkyo-ku, Tokyo, 113-8421, Japan
TEL
03-3813-3111
kazuhironanami@gmail.com
Public contact
Name of contact person
| 1st name | Yoko |
| Middle name | |
| Last name | Nishimura |
Organization
Juntendo University Faculty of Medicine
Division name
Departments of Obstetrics and Gynecology
Zip code
113-8421
Address
2-1-1, Hongo, Bunkyo-ku, Tokyo, 113-8421, Japan
TEL
03-3813-3111
Homepage URL
y-fujiura@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
Poppins Corporation Inc.
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
Research Ethics Committee, Faculty of Medicine, Juntendo University
Address
3-1-3, Hongo, Bunkyo-ku, Tokyo, Japan
Tel
03-5802-1584
hongo-rinri@juntendo.ac.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
| 2023 | Year | 08 | Month | 02 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 07 | Month | 06 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 06 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 06 | Day |
Last follow-up date
| 2024 | 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
| 2023 | Year | 08 | Month | 02 | Day |
Last modified on
| 2023 | Year | 08 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059104
