UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047385 |
|---|---|
| Receipt number | R000054035 |
| Scientific Title | Archival hysteroscopic image-based prediction for histopathologic chronic endometritis in infertile women using deep learning model |
| Date of disclosure of the study information | 2022/04/04 |
| Last modified on | 2024/01/04 15:48:06 |
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Basic information
Public title
Archival hysteroscopic image-based prediction for histopathologic chronic endometritis in infertile women using deep learning model
Acronym
ARChival Hysteroscopic Image-based Prediction for histopathologic chronic Endometritis in infertile women using deep LeArninG mOdel (ARCHIPELAGO Study)
Scientific Title
Archival hysteroscopic image-based prediction for histopathologic chronic endometritis in infertile women using deep learning model
Scientific Title:Acronym
ARChival Hysteroscopic Image-based Prediction for histopathologic chronic Endometritis in infertile women using deep LeArninG mOdel (ARCHIPELAGO Study)
Region
| Japan |
Condition
Condition
Chronic endometritis
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the feasibility of the archival hysteroscopic image-based deep learning model to predict histopathologic chronic endometritis in infertile women.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To train the originally developed deep learning model using archival hysteroscopic and histopathologic images of infertile women and evaluate the feasibility to clinical diagnosis of chronic endometritis.
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
| 50 | years-old | > |
Gender
Female
Key inclusion criteria
Infertile women undergoing hysteroscopy and endometrial biopsy/histopathologic examinations in search of chronic endometritis.
Key exclusion criteria
Other women.
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | Kotaro |
| Middle name | |
| Last name | Kitaya |
Organization
Kouseikai Mihara Hospital
Division name
Infertility Center
Zip code
615-8227
Address
6-8 Kamikatsura Miyanogo-cho, Nishikyo-ku, Kyoto
TEL
+81-75-392-3111
kitaya@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | Kotaro |
| Middle name | |
| Last name | Kitaya |
Organization
Kouseikai Mihara Hospital
Division name
Infertility Center
Zip code
615-8227
Address
6-8 Kamikatsura Miyanogo-cho, Nishikyo-ku, Kyoto
TEL
+81-75-392-3111
Homepage URL
kitaya@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kouseikai Mihara Hospital
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
Kouseikai Mihara Hospital
Address
6-8 Kamikatsura Miyanogo-cho, Nishikyo-ku, Kyoto, Japan
Tel
+81-75-392-3111
kitaya@mihara.com
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
| 2022 | Year | 04 | Month | 04 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000054035
Publication of results
Unpublished
Result
URL related to results and publications
Analysis Ongoing
Number of participants that the trial has enrolled
1270
Results
Analaysis Ongoing
Results date posted
| 2023 | Year | 12 | Month | 23 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Analaysis Ongoing
Participant flow
Analaysis Ongoing
Adverse events
Analaysis Ongoing
Outcome measures
Analaysis Ongoing
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2022 | Year | 02 | Month | 12 | Day |
Date of IRB
| 2022 | Year | 02 | Month | 28 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 04 | Day |
Last follow-up date
| 2022 | Year | 05 | Month | 09 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2022 | Year | 04 | Month | 04 | Day |
Last modified on
| 2024 | Year | 01 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054035
