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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000036050
Receipt No. 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 2019/05/30

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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
Obsterics 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
Email 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
Email nanakoiwami@gmail.com

Sponsor
Institute Kamiya Ladies Clinic
Institute
Department

Funding Source
Organization IGENOMIX JAPAN K.K.
Organization
Division
Category of Funding Organization Profit organization
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
Email 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 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
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
2020 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 02 Month 28 Day
Last modified on
2019 Year 05 Month 30 Day


Link to view the page
URL(English) https://upload.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


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