UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023333 |
|---|---|
| Receipt number | R000026886 |
| Scientific Title | Effect of intrauterine microbial colonization on reproductive outcome in infertile women undergoing assisted reproductive technology |
| Date of disclosure of the study information | 2016/07/27 |
| Last modified on | 2017/07/27 22:31:39 |
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Basic information
Public title
Effect of intrauterine microbial colonization on reproductive outcome in infertile women undergoing assisted reproductive technology
Acronym
Effect of intrauterine microbial colonization on reproductive outcome
Scientific Title
Effect of intrauterine microbial colonization on reproductive outcome in infertile women undergoing assisted reproductive technology
Scientific Title:Acronym
Effect of intrauterine microbial colonization on reproductive outcome
Region
| Japan |
Condition
Condition
Infertility
Classification by specialty
| Obstetrics 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
| 1st name | |
| Middle name | |
| Last name | Khaleque Khan |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of obstetrics and gynecology
Zip code
Address
Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, JAPAN.
TEL
075-251-5560
nemokhan@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Okimura |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of obstetrics and gynecology
Zip code
Address
Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, JAPAN.
TEL
070-251-5560
Homepage URL
h-okim@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
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
| 2016 | Year | 07 | Month | 26 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026886
