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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000031731
Receipt No. R000036121
Scientific Title Analysis of vaginal and uterine microbiota of infertile and recurrent miscarriage patients
Date of disclosure of the study information 2018/03/15
Last modified on 2018/03/17

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Basic information
Public title Analysis of vaginal and uterine microbiota of infertile and recurrent miscarriage patients
Acronym Analysis of vaginal and uterine microbiota of infertile and recurrent miscarriage patients
Scientific Title Analysis of vaginal and uterine microbiota of infertile and recurrent miscarriage patients
Scientific Title:Acronym Analysis of vaginal and uterine microbiota of infertile and recurrent miscarriage patients
Region
Japan

Condition
Condition infertility and recurrent miscarriage
Classification by specialty
Obsterics and gynecology
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 To clarify the etiology of nfertility and recurrent miscarriage using vaginal and uterine microbiota
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The association between microbiota and implantation rate and livebirth rate.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -but assessor(s) are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine Other
Interventions/Control_1 vaginal and uterine cavity secretion and endometrial tissue collection from test subjects
Interventions/Control_2 vaginal and uterine cavity secretion and endometrial tissue collection from test subjects after treatments by antibiotics and/or probiotics/prebiotics administration

<antibiotics>
1. doxycycline 200mg (100mg tablet, twice a day) for 14 days
2. ciprofloxacin 600mg(200mg tablet, three times a day) for 10 days
3. amoxicillin 1000mg(250mg capsule, four times a day) for 8 days
4. josamycin 1200mg(200mg two tablets, three times a day) for 12 days
<probiotics/prebiotics>
1. lactoferrin 700mg(100mg seven tablets, once time a day ) for more than four weeks
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
45 years-old >=
Gender Female
Key inclusion criteria Infertile patients requiring artificial reproductive technology and recurrent miscarriage patients
Key exclusion criteria None
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takuhiko Ichiyama
Organization St.Mother Hospital
Division name Department of obstetrics and gynecology
Zip code
Address 4-9-12 Orio Yahatanishi-ku Kitakyusyu city Fukuoka Japan
TEL 81-93-601-2000
Email peacety0218@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takuhiko Ichiyama
Organization St.Mother Hospital
Division name Department of obstetrics and gynecology
Zip code
Address 4-9-12 Orio Yahatanishi-ku Kitakyusyu city Fukuoka Japan
TEL 81-93-601-2000
Homepage URL
Email incho@stmother.com

Sponsor
Institute St.Mother Hospital
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
Address
Tel
Email

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
2018 Year 03 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 Open public recruiting
Date of protocol fixation
2017 Year 10 Month 12 Day
Date of IRB
Anticipated trial start date
2017 Year 10 Month 12 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 03 Month 14 Day
Last modified on
2018 Year 03 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036121

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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