UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of intrauterine microbial colonization on reproductive outcome in infertile women undergoing assisted reproductive technology
Title of the study (Brief title)	Effect of intrauterine microbial colonization on reproductive outcome
Region	Japan

Condition
Condition	Infertility
Classification by specialty	Obsterics and gynecology
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	We plan to detect bacteria in endometrial samples using metagenomic analysis and clarify the effect on reproductive outcome in women undergoing ART.
Basic objectives2	Others
Basic objectives -Others	To detect bacteria in endometrial samples by metagenomic analysis.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The association between intrauterine microbial colonization and implantation rate.
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	Not applicable
Age-upper limit	Not applicable
Gender	Female
Key inclusion criteria	Infertile women undergoing her first embryo or blastocyst transfer.
Key exclusion criteria	No
Target sample size	100

Research contact person
Name of lead principal investigator	Khaleque Khan
Organization	Kyoto Prefectural University of Medicine
Division name	Department of obstetrics and gynecology
Address	Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, JAPAN.
TEL	075-251-5560
Email	nemokhan@koto.kpu-m.ac.jp

Public contact
Name of contact person	Hiroyuki Okimura
Organization	Kyoto Prefectural University of Medicine
Division name	Department of obstetrics and gynecology
Address	Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, JAPAN.
TEL	070-251-5560
Homepage URL
Email	h-okim@koto.kpu-m.ac.jp

Sponsor
Institute	Kyoto Prefectural University of Medicine
Institute
Department

Funding Source
Organization	Kyoto Prefectural University of Medicine
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	Oak Clinic
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	2016 Year 07 Month 27 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2016 Year 07 Month 26 Day
Anticipated trial start date	2016 Year 07 Month 27 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	Results of metagenomic analysis

Management information
Registered date	2016 Year 07 Month 26 Day
Last modified on	2017 Year 07 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000026886