UMIN-CTR Clinical Trial

Basic information
Public title	Relationship between intrauterine microbiota and IVF outcomes
Acronym	Relationship between intrauterine microbiota and IVF outcomes
Scientific Title	Relationship between intrauterine microbiota and IVF outcomes
Scientific Title:Acronym	Relationship between intrauterine microbiota and IVF outcomes
Region	Japan

Condition
Condition	IVF Reccurent Failure
Classification by specialty	Obsterics and gynecology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Understanding the role of the intrauterine flora in pregnancy
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Pregnancy rate, implantation rate, abortion rate
Key secondary outcomes	Concentration of Lactobacillus and Bifidobacterium

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Lactobacillus and antibiotic treatment IVF-ET enforced.
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	50 years-old >=
Gender	Female
Key inclusion criteria	IVF recurrent Failure
Key exclusion criteria	none
Target sample size	100

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	1-17-28 Minamihorie Nishi-ku Osaka JAPAN
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	1-17-28 Minamihorie Nishi-ku Osaka JAPAN
TEL	09014417520
Homepage URL
Email	kadogami515@ivfjapan.com

Sponsor
Institute	IVF Namba Clinic
Institute
Department

Funding Source
Organization	IVF Namba Clinic
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 Namba Clinic
Address	1-17-28 Minamihorie Nishi-ku Osaka JAPAN
Tel	0665348824
Email	kadogami515@ivfjapan.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	2020 Year 08 Month 22 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	2020 Year 01 Month 01 Day
Date of IRB	2018 Year 11 Month 19 Day
Anticipated trial start date	2020 Year 04 Month 01 Day
Last follow-up date	2022 Year 01 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 08 Month 21 Day
Last modified on	2020 Year 08 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047389