UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036050 |
|---|---|
| Receipt number | R000041006 |
| Scientific Title | The analysis of endometrial microbiota using the test named EMMA/ALICE to improve reproductive outcomes in infertile patients |
| Date of disclosure of the study information | 2019/03/01 |
| Last modified on | 2023/01/06 09:56:18 |
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Basic information
Public title
The analysis of endometrial microbiota using the test named EMMA/ALICE to improve reproductive outcomes in infertile patients
Acronym
EMMA/ALICE for RIF or RPL in Japan 2019
Scientific Title
The analysis of endometrial microbiota using the test named EMMA/ALICE to improve reproductive outcomes in infertile patients
Scientific Title:Acronym
EMMA/ALICE for RIF or RPL in Japan 2019
Region
| Japan |
Condition
Condition
Chronic endometritis
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the uterine microbiota and bacteria cause of chronic endometritis
Basic objectives2
Others
Basic objectives -Others
To evaluate the effect of the antibiotic therapy for chronic endometritis (CE) on IVF outcome
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase IV
Assessment
Primary outcomes
The clinical pregnancy rate of the patients whose results are abnormal in EMMA/ALICE and after that who have treated with probiotics therapy
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Endometrial tissue will be obtained by aspiration from these patients on the day of endometrial biopsy in day 15-25 of menstrual cycle. Samples of these patients will ill be used for the non-invasive diagnosis of the endometrial factor and microbiome by NGS.
Interventions/Control_2
Those patients dominated by bacteria of the genus Lactobacillus will continue their ART according to the standard protocol of the clinic. Those patients without dominated by bacteria of the genus Lactobacillus will follow the recommendation therapy, after a second endometrium sample will be obtained, in which the collection of endometrium sample will be repeated as previously described. Finally, the endometrial factor will be correlated with that on the endometrial tissue and the microbiome according to the reproductive outcomes of these patients following the first embryo transfer performed after the sample collection
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
| 46 | years-old | > |
Gender
Female
Key inclusion criteria
1, The patients who has IVF-ET therapy
2, The duration of infertility over 3 years
3,Infertile women with history of recurrent implantation failure, defined as three or more failed ETs, undergoing one or more IVF cycle(s).t
4, Infertile women with history of recurrent pregnancy loss, defined as two ore more
5, Infertile women with history of recurrent chemical pregnancy, defined as two ore more
6,The patients suspected CE by hysteroscope
7,The patients who detected CD138 positive plasma cells in historical tissues
8, The patients who had bacterial vaginosis
9,BMI: 18.5 - 30 kg / m2 (both inclusive)
10,HIV, HBV, HCV, RPR negative
Key exclusion criteria
1, The patients who has endometrial polyp, submucosal myopia, Asherman syndrome, scar of C/S in uterus.
2,Any social, medical, or psychiatric condition
3, The couple or their parents who has chromosomal aberration or carrier of translocation
4, The patients with untreated hydrosalpinx
5, Known allergy to any component of antibiotic therapy
6,,Vaginal or systemic antibiotic therapy within 3 months
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Hirobumi |
| Middle name | |
| Last name | Kamiya |
Organization
Kamiya Ladies Clinic
Division name
Reproductive Center
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
Kamiya Ladies Clinic
Division name
Reproductive Center
Zip code
060003
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
Self funding
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
Tel
011-231-2722
kamiya@fine.ocn.ne.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
| 2019 | Year | 03 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
200
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
Main results already published
Date of protocol fixation
| 2019 | Year | 02 | Month | 04 | Day |
Date of IRB
| 2019 | Year | 02 | Month | 23 | Day |
Anticipated trial start date
| 2019 | Year | 02 | Month | 24 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2022 | Year | 09 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 02 | Month | 28 | Day |
Last modified on
| 2023 | Year | 01 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041006
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
| 2022/10/19 | Data sets updates2.xlsx |
