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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000038582
Receipt No. 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 2019/11/14

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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
Obsterics 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 09014417520
Email 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 09014417520
Homepage URL
Email kadogami515@ivfjapan.com

Sponsor
Institute IVF Namba Clinic
Institute
Department

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
Email 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
2019 Year 11 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043939

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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