UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029449 |
|---|---|
| Receipt number | R000033645 |
| Scientific Title | Uterine cavity/vagina microbiota in infertile patients with repeated implantation failure |
| Date of disclosure of the study information | 2017/10/06 |
| Last modified on | 2022/06/03 03:48:22 |
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Basic information
Public title
Uterine cavity/vagina microbiota in infertile patients with repeated implantation failure
Acronym
Uterine cavity/vagina microbiota in infertile patients with repeated implantation failure
Scientific Title
Uterine cavity/vagina microbiota in infertile patients with repeated implantation failure
Scientific Title:Acronym
Uterine cavity/vagina microbiota in infertile patients with repeated implantation failure
Region
| Japan |
Condition
Condition
repeated implantation failure
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To clarify the etiology and pathogenesis of repeated implantation failure using uterine cavity/vagina microbiota.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Microbial composition and proportion in the uterine cavity and vagina
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
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
Uterine cavity and vaginal secretion collection from infertile patients with repeated implantation failure
Interventions/Control_2
Uterine cavity and vaginal secretion collection from infertile patients undergoing first embryo transfer attempt in the following cycle
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 women requiring artificial reproductive technology
Key exclusion criteria
Infertile women lacking anatomical uterus and/or vagina
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Kotaro |
| Middle name | |
| Last name | Kitaya |
Organization
Reproduction Clinic Osaka
Division name
IVF Center
Zip code
5300011
Address
Grand Front Osaka, Tower-A 15F, 4-20 Oofuka-cho, Kita-ku, Osaka, 530-0011, Japan
TEL
0661363344
kitaya@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | Kotaro |
| Middle name | |
| Last name | Kitaya |
Organization
Reproduction Clinic Osaka
Division name
IVF Center
Zip code
530-0011
Address
Grand Front Osaka, Tower-A 15F, 4-20 Oofuka-cho, Kita-ku, Osaka, 530-0011, Japan
TEL
0661363344
Homepage URL
kitaya@koto.kpu-m.ac.jp
Sponsor or person
Institute
Reproduction Clinic Osaka
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Reproduction Clinic Osaka
Address
Grand Front Osaka, Tower-A 15F, 4-20 Oofuka-cho, Kita-ku, Osaka, 530-0011, Japan
Tel
0661363344
kitaya@koto.kpu-m.ac.jp
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
| 2017 | Year | 10 | Month | 06 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
123
Results
Differential Vaginal Microbiota Profiling in Lactic-Acid-Producing Bacteria between Infertile Women with and without Chronic Endometritis
Suguru E. Tanaka,Yoshiyuki Sakuraba,
Kotaro Kitaya,Tomomoto Ishikawa
Diagnostics 2022, 12(4), 878;
https://doi.org/10.3390/diagnostics12040878
Results date posted
| 2022 | Year | 04 | Month | 05 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2022 | Year | 03 | Month | 31 | Day |
Baseline Characteristics
Participant flow
Adverse events
None
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2007 | Year | 08 | Month | 10 | Day |
Date of IRB
| 2017 | Year | 09 | Month | 10 | Day |
Anticipated trial start date
| 2017 | Year | 10 | Month | 06 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 10 | Month | 06 | Day |
Last modified on
| 2022 | Year | 06 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033645
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
