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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000036917
Receipt No. R000042039
Scientific Title Efficacy evaluation study for EMMA and ALICE test in multi-centers. A joint research with Japanese Institution for Standardizing Assisted Reproductive Technology (JISART)
Date of disclosure of the study information 2019/06/01
Last modified on 2019/06/01

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Basic information
Public title Efficacy evaluation study for EMMA and ALICE test in multi-centers.
A joint research with Japanese Institution for Standardizing Assisted Reproductive Technology (JISART)
Acronym EMMA/ALICE efficacy evaluation
Scientific Title Efficacy evaluation study for EMMA and ALICE test in multi-centers.
A joint research with Japanese Institution for Standardizing Assisted Reproductive Technology (JISART)
Scientific Title:Acronym EMMA/ALICE efficacy evaluation
Region
Japan

Condition
Condition Infectious Chronic Endometritis
Classification by specialty
Obsterics and gynecology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To improve pregnancy rate and ongoing pregnancy rate and decrease miscarriage rate of IVF treatments using EMMA/ALICE.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II,III

Assessment
Primary outcomes Ongoing pregnancy rate.
Participant centers should treat the patients following the descriptions specified in EMMA/ALICE reports, antibiotic treatments, probiotic treatments, re-analysis, and embryo transfer after re-analysis. All patients participating in this study should obtain re-analysis if necessary. Data of ongoing pregnancy rates should be collected by participant centers after embryo implantation for analysis.
Key secondary outcomes 1.One variable per each microorganism identified in endometrial biopsy.
2.Microbiome found in endometrial biopsy (LD/NLD)
Presence of bacterial microbiome; Identified bacteria are classified into the following two groups:
Group 1 (LD): Lactobacillus dominated microbiome (>90% Lactobacillus spp.), composed of different species of the genus Lactobacillus: L. crispatus, L. gasseri, L. iners, L.jensenii, among others.
Group 2 (NLD): non-Lactobacillus dominated microbiome (<90% Lactobacillus spp. with at least 10% of dysbiotic bacteria), formed by species that modify the physiological endometrial conditions, therefore decreasing the prevalence of Lactobacillus
Analysis implantation rate, Live Birth rates and Miscarriage rate after embryo implantation.

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 Endometrial tissue will be obtained from patients by aspiration using a Pipelle catheter (or similar) on 15-25 day of menstrual cycle and will be used for the diagnosis of the microbiome by Next-generation sequencing(NGS).
Interventions/Control_2 EMMA Reports with [Normal] result, which indicate the patients with endometrial microbiome dominated by genus Lactobacillus, will continue their ART treatments according to the standard protocol of the clinic. Patients with [Abnormalresult], which their endometrial microbiome dominated by non-Lactobacillus genus, will follow the recommended therapy and will undergo a second endometrium sampling and testing. Embryo transfer for these patients should be performed after their microbiome have been corrected.
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
40 years-old >=
Gender Female
Key inclusion criteria 1, Patients undergoing ART treatments in JISART registered institutions, with scheduled embryo implantation
2, Patients who can perform re-examination if necessary
Key exclusion criteria 1, Patients with intrauterine lesions (surgically-adapted uterine submucosal myomas and endometrial polyps, Asherman syndrome, cesarean section scarring syndrome, etc.)
2, Patients with metabolic abnormality (thyroid disease of poor control etc.) and medical complication
3, Couples, or their parents, with abnormal chromosomes, including translocation
4, Patients with fallopian cysts without medical treatments
5, Patients with allergy to antibiotics, or patients who cannot follow antibiotic treatments
6, Patients who have taken prescribed antibiotics at least 3 months before the sample collection. (Cases where the patient has received previous prophylactic antibiotics to ovarian puncture in the stimulation cycle, according to the standard clinical practice of the clinic, may be accepted if the administration of the antibiotic was made at least 1 month before the sample collection).
7, Patients who have taken antibiotics other than those recommended by EMMA/ALICE between sample collection and embryo transfer.
8, Any illness or medical condition that is unstable or can put patient safety at risk and compromise the compliance of the study.
Target sample size 500

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 060003
Address Nittsu-Sapporo Bldg 2F 2-1 Nishi 2-chome Kita 3-Jo Chuo-ku, Sapporo 060-0003 Japan
TEL 0112312722
Email kamiya@fine.ocn.ne.jp

Public contact
Name of contact person
1st name Rie
Middle name
Last name HIrokawa
Organization The Japanese Institution for Standardizing Assisted Reproductive Technology (JISART)
Division name Reproductive Health
Zip code 5300002
Address MF Sakurabashi Bldg 5F 2-6-23 Shinchi Sonesaki Kita-Ku Osaka 5300002 Japan
TEL 0661319741
Homepage URL
Email jimukyoku@jisart.jp

Sponsor
Institute The Japanese Institution for Standardizing Assisted Reproductive Technology (JISART)
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 IRB at the Japanese Institution for Standardizing Assisted Reproductive Technology (JISART)
Address MF Sakurabashi Bldg 5F 2-6-23 Shinchi Sonesaki Kita-Ku Osaka 5300002 Japan
Tel 0661319741
Email jimukyoku@jisart.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 ART Women’s Clinic(Kumamoto), IVF Osaka Clinic(Osaka), IVF Nagata Clinic(Osaka), IVF Namba Clinic(Osaka), Asada Ladies Clinic(Aichi), Asada Ladies Nagoya Clinic(Aichi), Umegaoka Women’s Clinic(Tokyo), Okayama Couple's Clinic(Okayama), Kamiya Ladies Clinic(Hokkaido), Kinutani Women’s Clinic (HIroshima), Kiba Park Clinic(Tokyo), Kyono ART Clinic (Tokyo), Kuramoto Women’s Clinic (Fukuoka), Clinic Mama (Gihu), Sekiel Ladies Clinic (Gunma), St. Mother Hospital (Fukuoka), Daigo Watanabe Clinic (Kyoto), Sendai ART Clinic (Miyagi), Takeuchi Ladies Clinic (Kagoshima), Hanabusa Women’s Clinic (Hyogo), Hiroshima HART Clinic (Hiroshima), Fertility Clinic Tokyo (Tokyo), Horac IVF Grand Front Osaka (Osaka) Clinic, Mio Fertility Clinic (Tottori)

Other administrative information
Date of disclosure of the study information
2019 Year 06 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 01 Month 10 Day
Date of IRB
2019 Year 01 Month 08 Day
Anticipated trial start date
2019 Year 06 Month 01 Day
Last follow-up date
2020 Year 05 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
2019 Year 06 Month 01 Day
Last modified on
2019 Year 06 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042039

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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