UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057283 |
|---|---|
| Receipt number | R000065481 |
| Scientific Title | A prospective comparative study on the efficacy of endometrial shaving using a tissue removal system versus conventional antibiotic treatment in infertile patients with chronic endometritis |
| Date of disclosure of the study information | 2025/03/18 |
| Last modified on | 2025/05/21 13:51:07 |
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Basic information
Public title
A prospective comparative study on the efficacy of endometrial shaving using a tissue removal system versus conventional antibiotic treatment in infertile patients with chronic endometritis
Acronym
A prospective comparative study on the efficacy of endometrial shaving using a tissue removal system versus conventional antibiotic treatment in infertile patients with chronic endometritis
Scientific Title
A prospective comparative study on the efficacy of endometrial shaving using a tissue removal system versus conventional antibiotic treatment in infertile patients with chronic endometritis
Scientific Title:Acronym
A prospective comparative study on the efficacy of endometrial shaving using a tissue removal system versus conventional antibiotic treatment in infertile patients with chronic endometritis
Region
| Japan |
Condition
Condition
Infertility patients with chronic endometritis
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study compare reproductive outcomes between a group receiving conventional antibiotic treatment and a group receiving endometrial curettage using a tissue removal system for chronic endometritis, and examine the safety and effectiveness of endometrial curettage using a tissue removal system for chronic endometritis.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Clinical pregnancy rate per embryo transfer cycle
Key secondary outcomes
CD138 positive cell count before and after chronic endometritis treatment. Time to cure of chronic endometritis.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
A group that will undergo endometrial curettage using a tissue removal system.
Interventions/Control_2
A group that will receive conventional antibiotic treatment (two weeks administration of Vibramycin)
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
| 18 | years-old | <= |
Age-upper limit
| 50 | years-old | > |
Gender
Female
Key inclusion criteria
Patients who visited the hospital for assisted reproductive technology, had a positive chronic endometritis test, met the following eligibility criteria, and did not violate any of the exclusion criteria will be included in the study.
-Those who provided written informed consent to participate in the study.
Key exclusion criteria
-Those who have not given consent
-Those who are deemed inappropriate by the principal investigator or co-investigator
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | Tomomoto |
| Middle name | |
| Last name | Ishikawa |
Organization
Reproduction Clinic Osaka
Division name
Reproductive medicine
Zip code
530-0011
Address
4-20, Ofuka-cho, Kita-Ku, Osaka, Japan
TEL
06-6136-3344
yohara@reposaka.jp
Public contact
Name of contact person
| 1st name | Satoru |
| Middle name | |
| Last name | Sumori |
Organization
Reproduction Clinic Osaka
Division name
General Affairs Department
Zip code
530-0011
Address
4-20, Ofuka-cho, Kita-Ku, Osaka, Japan
TEL
06-6136-3344
Homepage URL
ssumori@reposaka.jp
Sponsor or person
Institute
Reproduction Clinic Osaka
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
Reproduction Clinic Osaka
Address
4-20, Ofuka-cho, Kita-Ku, Osaka, Japan
Tel
06-6136-3344
ssumori@reposaka.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 | 18 | 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
| 2025 | Year | 03 | Month | 05 | Day |
Date of IRB
| 2025 | Year | 03 | Month | 05 | Day |
Anticipated trial start date
| 2025 | Year | 03 | Month | 05 | Day |
Last follow-up date
| 2028 | Year | 12 | 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
| 2025 | Year | 03 | Month | 14 | Day |
Last modified on
| 2025 | Year | 05 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065481
