UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045730 |
|---|---|
| Receipt number | R000051962 |
| Scientific Title | Efficacy of endometrial microbiome metagenomic analysis and analysis of infectious chronic endometritis |
| Date of disclosure of the study information | 2022/02/01 |
| Last modified on | 2025/04/16 02:41:11 |
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Basic information
Public title
Efficacy of endometrial microbiome metagenomic analysis (EMMA)and analysis of infectious chronic endometritis (ALICE)
Acronym
Efficacy of EMMA/ALICE
Scientific Title
Efficacy of endometrial microbiome metagenomic analysis and analysis of infectious chronic endometritis
Scientific Title:Acronym
Efficacy of EMMA/ALICE
Region
| Japan |
Condition
Condition
Repeated implantation failure, repeated pregnancy loss, chronic endometritis
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
By analyzing the 16S ribosomal RNA of bacteria in the uterine endometrium fluid using a new generation sequencer (NGS), the percentage of Lactobacillus species and the distribution of other bacterial flora will be clarified. Based on the results, the groups that need antibiotics to optimize the intrauterine environment and those that do not need antibiotics will be divided to avoid unnecessary administration of antibiotics. If antibiotics are necessary, we will use optimal antibiotics according to the detected bacteria to avoid future risks of antibiotic overuse, such as the emergence of resistant bacteria in patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase IV
Assessment
Primary outcomes
Ongoing pregnancy rate; Comparison of ongoing pregnancy rates between the normal uterine microbiota group and the treatment intervention group (after treatment intervention for Lactobacillus <90%)
Key secondary outcomes
1,Detection of the percentage of patients with recurrent implantation failure, recurrent miscarriages, and patients suspected of CE by other tests whose intrauterine flora is actually dominated by pathogenic bacteria other than Lactobacillus species.
2,Impact on implantation rate and clinical pregnancy rate in patients with recurrent implantation failure and recurrent miscarriage after this test
3,Verify the concordance rate with vaginal culture and hysteroscopy.
4,Frequency of complications from the test such as pain, infection, uterine perforation, and vagus reflex
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Suggest EMMA/ALICE test and perform the same for patients who requested the tests
Interventions/Control_2
Explain the results to the study participants based on the test result reports, and
validate subsequent tests and additional treatments.
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
| 18 | years-old | <= |
Age-upper limit
| 42 | years-old | >= |
Gender
Female
Key inclusion criteria
1,Repeated implantation failure with no clinical pregnancy after two or more implantations.
2,Repeated miscarriages (two or more previous miscarriages)
3,Patients with difficult-to-treat cases of bacterial vaginosis
4, Patients suspected of having chronic endometritis by the hysteroscopy
Key exclusion criteria
Untreated Fallopian Tube Hydrops.
Intrauterine lesions (endometrial polyps, submucosal fibroids, etc.)
The patient has received antibiotics 3 months prior to the test.
Have a serious medical condition.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Hirobumi |
| Middle name | |
| Last name | Kamiya |
Organization
Kaimiya ladies clinic
Division name
Reproductive health
Zip code
0600003
Address
Nittsu-Sapporo Bldg 2F 2-1 Nishi 2-chome Kita 3-Jo Chuo-ku, Sapporo 060-0003 Japan
TEL
011-231-2722
kamiya@fine.ocn.ne.jp
Public contact
Name of contact person
| 1st name | Nanako |
| Middle name | |
| Last name | Iwami |
Organization
Kaimiya ladies clinic
Division name
Reproductive health
Zip code
060063
Address
Nittsu-Sapporo Bldg 2F 2-1 Nishi 2-chome Kita 3-Jo Chuo-ku, Sapporo 060-0003 Japan
TEL
011-231-2722
Homepage URL
nanakoiwami@gmail.com
Sponsor or person
Institute
Kamiya ladies clinic
Institute
Department
Personal name
Funding Source
Organization
Kamiya ladies clinic
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
Kamiya ladies clinic
Address
Nittsu-Sapporo Bldg 2F 2-1 Nishi 2-chome Kita 3-Jo Chuo-ku, Sapporo 060-0003 Japan
Tel
011-231-2722
tozawa@kamiyaclinic.com
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
神谷レディースクリニック（北海道）、蔵本ウイメンズクリニック（福岡県）、岡山二人クリニック（岡山県）、クリニックママ（岐阜県）、セキールレディースクリニック（群馬県）、仙台ARTクリニック（宮城県）、セントマザー産婦人科医院（福岡県）、醍醐渡辺クリニック（京都府）、英ウィメンズクリニック（兵庫県）、ミオ・ファティリティ・クリニック（鳥取県）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 02 | Month | 01 | 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
| 2021 | Year | 09 | Month | 07 | Day |
Date of IRB
| 2021 | Year | 09 | Month | 10 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2025 | 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
| 2021 | Year | 10 | Month | 12 | Day |
Last modified on
| 2025 | Year | 04 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051962
