UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Analysis of vaginal and uterine microbiota of infertile and recurrent miscarriage patients
Title of the study (Brief title)	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	Takuhiko Ichiyama
Organization	St.Mother Hospital
Division name	Department of obstetrics and gynecology
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	Takuhiko Ichiyama
Organization	St.Mother Hospital
Division name	Department of obstetrics and gynecology
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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2017 Year 10 Month 12 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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