UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057365 |
|---|---|
| Receipt number | R000065466 |
| Scientific Title | Retrospective Analysis of Adenomyomectomy for Uterine Adenomyosis |
| Date of disclosure of the study information | 2025/03/22 |
| Last modified on | 2025/03/23 12:26:14 |
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Basic information
Public title
Retrospective Collection and Analysis of Clinical Data on Adenomyomectomy
Acronym
Retrospective Collection and Analysis of Clinical Data on Adenomyomectomy
Scientific Title
Retrospective Analysis of Adenomyomectomy for Uterine Adenomyosis
Scientific Title:Acronym
Retrospective Analysis of Adenomyomectomy for Uterine Adenomyosis
Region
| Japan |
Condition
Condition
Adenomyosis
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to investigate the current status of adenomyomectomy in Japan and to retrospectively evaluate its safety and efficacy.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comprehensive data will be systematically collected from patients who have undergone adenomyomectomy in Japan, including obstetric history, presenting symptoms, prior treatments, imaging findings, clinical outcomes, and perinatal outcomes following postoperative pregnancies.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Patients who underwent adenomyomectomy for uterine adenomyosis at one of the 1,158 facilities registered with the Japan Society of Obstetrics and Gynecology (JSOG) as of February 1, 2023.
Patients who underwent adenomyomectomy for uterine adenomyosis during the 3-year period from January 1, 2020, to December 31, 2022.
Key exclusion criteria
Patients deemed inappropriate for inclusion by the attending physician's judgment.
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Yasushi |
| Middle name | |
| Last name | Hirota |
Organization
Graduate School of Medicine, The University of Tokyo
Division name
Department of Obstetrics and Gynecology
Zip code
113-8655
Address
7-3-1 Hongo Bunkyo Tokyo
TEL
0338155411
hirotay-gyn@h.u-tokyo.ac.jp
Public contact
Name of contact person
| 1st name | Mitsunori |
| Middle name | |
| Last name | Matsuo |
Organization
The University of Tokyo Hospital
Division name
Department of Obstetrics and Gynecology
Zip code
113-8655
Address
7-3-1 Hongo Bunkyo Tokyo
TEL
0338155411
Homepage URL
matsuom-gyn@h.u-tokyo.ac.jp
Sponsor or person
Institute
The University of Tokyo
Institute
Department
Personal name
Mitsunori Matsuo
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Research Ethics Committee, Faculty of Medicine, The University of Tokyo
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo 113-0033, Japan
Tel
03-5841-1069
med-ethics@umin.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
| 2025 | Year | 03 | Month | 22 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 07 | Month | 17 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 02 | Day |
Anticipated trial start date
| 2024 | Year | 08 | Month | 06 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2025 | Year | 03 | Month | 22 | Day |
Last modified on
| 2025 | Year | 03 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065466
