UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038582 |
|---|---|
| Receipt number | R000043939 |
| Scientific Title | Examination of therapeutic effects of intrauterine microbiota by antibiotics, Probiotics and Prebiotics |
| Date of disclosure of the study information | 2019/11/14 |
| Last modified on | 2021/08/03 11:59:56 |
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Basic information
Public title
Establishment of treatment method for intrauterine microbiota
Acronym
Establishment of treatment method for intrauterine microbiota
Scientific Title
Examination of therapeutic effects of intrauterine microbiota by antibiotics, Probiotics and Prebiotics
Scientific Title:Acronym
Examination of therapeutic effects of intrauterine microbiota by antibiotics, Probiotics and Prebiotics
Region
| Japan |
Condition
Condition
Intrauterine microbiota abnormalities
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Establishment of treatment for Intrauterine microbiota abnormalities
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Percentage of Lactobacillus and Bifidobacterium in Intrauterine microbiota
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
NO
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
6
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Probiotics(oral medicine 3g/day)30days
Prebiotics(oral medicine 300mg/day)30days
Interventions/Control_2
antibiotics(oral medicine 750mg/day)7days
antibiotics(Vaginal tablet 250mg)1 time
Interventions/Control_3
Probiotics(oral medicine 3g/day)30days
Prebiotics(oral medicine 300mg/day)30days
antibiotics(oral medicine 750mg/day)7days
antibiotics(Vaginal tablet 250mg)1 time
Interventions/Control_4
Probiotics(oral medicine 3g/day)30days
Prebiotics(oral medicine 600mg/day)30days
antibiotics(oral medicine 750mg/day)7days
antibiotics(Vaginal tablet 250mg/day)7days
Interventions/Control_5
Probiotics(Vaginal tablet 1cap/day)7days
Interventions/Control_6
Probiotics(Vaginal tablet 1cap/day)7days
antibiotics(oral medicine 750mg/day)7days
antibiotics(Vaginal tablet 250mg/day)7days
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
Repeated implantation failure
Less than 90% of Lactobacillus or Bifidobacterium in the uterine microbiota
Key exclusion criteria
History of uterine surgery
Target sample size
95
Research contact person
Name of lead principal investigator
| 1st name | DAISUKE |
| Middle name | |
| Last name | KADOGAMI |
Organization
IVF Namba Clinic
Division name
Doctor
Zip code
5500015
Address
Osaka-shi,Nishi-Ku,Minamihorie,1-17-28
TEL
0665348824
kadogami515@ivfjapan.com
Public contact
Name of contact person
| 1st name | DAISUKE |
| Middle name | |
| Last name | KADOGAMI |
Organization
IVF Namba Clinic
Division name
Doctor
Zip code
5500015
Address
Osaka-shi,Nishi-Ku,Minamihorie,1-17-28
TEL
0665348824
Homepage URL
kadogami515@ivfjapan.com
Sponsor or person
Institute
IVF Namba Clinic
Institute
Department
Personal name
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
IVF Japan
Address
Higashioosaka-shi,Nagatahigasi,1-1-14
Tel
0643088824
hirota@ivfoosaka.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
| 2019 | Year | 11 | Month | 14 | 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
| 2019 | Year | 11 | Month | 14 | Day |
Date of IRB
| 2018 | Year | 11 | Month | 19 | Day |
Anticipated trial start date
| 2019 | Year | 11 | Month | 14 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 11 | Month | 14 | Day |
Last modified on
| 2021 | Year | 08 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043939
