UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055467 |
|---|---|
| Receipt number | R000063374 |
| Scientific Title | Analysis of diagnostic criteria for chronic endometritis and endometrial dysbiosis affecting pregnancy outcomes in assisted reproductive technology |
| Date of disclosure of the study information | 2024/10/15 |
| Last modified on | 2025/03/11 09:29:26 |
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Basic information
Public title
Analysis of diagnostic criteria for chronic endometritis and endometrial dysbiosis affecting pregnancy outcomes in assisted reproductive technology
Acronym
Analysis of diagnostic criteria for chronic endometritis and abnormality of endometrial microbiota affecting pregnancy outcomes in IVF treatment
Scientific Title
Analysis of diagnostic criteria for chronic endometritis and endometrial dysbiosis affecting pregnancy outcomes in assisted reproductive technology
Scientific Title:Acronym
Diagnostic criteria for chronic endometritis and endometrial dysbiosis affecting pregnancy outcomes
Region
| Japan |
Condition
Condition
Infertility
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to investigate the diagnostic criteria for chronic endometritis and endometrial dysbiosis through comparison between the number of endometrial CD138 positive cells or the results of microbiome analysis and pregnancy outcomes after blastocyst transfer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The number of endometrial CD138 positive cells or the results of microbiome analysis for therapeutic targets
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
| 40 | years-old | > |
Gender
Female
Key inclusion criteria
Infertile women who have undergone assisted reproductive technology and meet the following conditions
(1) Under 40 years old
(2) History of one or more implantation failure after embryo transfer (including biochemical pregnancy)
(3) No intrauterine disorders after hysteroscopy or hysteroscopic surgery within 1 year
(4) hCG <5.0 mIU/mL at the day of pregnancy test
(5) No history of treatment for chronic endometritis
(6) No use of probiotics or lactoferrin supplements
(7) Women who have frozen morphologically good blastocysts (blastocysts without grade C of Gardner's classification) and will perform embryo transfer with their blastocysts in the next cycle
Key exclusion criteria
Women without the above diagnostic criteria
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Keiji |
| Middle name | |
| Last name | Kuroda |
Organization
Sugiyama Clinic Marunouchi
Division name
Center for Reproductive Medicine and Endoscopy
Zip code
100-0005
Address
1-6-2, Marunouchi, Chiyoda-ku, Tokyo
TEL
+81-(0)3-5222-1500
kuroda@sugiyama.or.jp
Public contact
Name of contact person
| 1st name | Sayaka |
| Middle name | |
| Last name | Kitagawa |
Organization
Sugiyama Clinic Marunouchi
Division name
Center for Reproductive Medicine and Endoscopy
Zip code
100-0005
Address
1-6-2, Marunouchi, Chiyoda-ku, Tokyo
TEL
+81-(0)3-5222-1500
Homepage URL
kuroda@sugiyama.or.jp
Sponsor or person
Institute
Sugiyama Clinic Marunouchi
Institute
Department
Personal name
Funding Source
Organization
Japan society for the promotion of science
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Sugiyama Clinic
Address
Nishi-shinjuku, 1-19-6, Shinjuku-ku, Tokyo
Tel
+81-(0)3-5381-3000
kuroda@sugiyama.or.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
| 2024 | Year | 10 | Month | 15 | 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 | 09 | Month | 08 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 18 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective observational study
Management information
Registered date
| 2024 | Year | 09 | Month | 09 | Day |
Last modified on
| 2025 | Year | 03 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063374
