UMIN-CTR Clinical Trial

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	0665348824
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	0665348824
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	2021 Year 08 Month 03 Day

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