UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036917 |
|---|---|
| Receipt number | 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 | 2023/06/06 16:25:36 |
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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
| Obstetrics 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
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
hirokawa@jisart.jp
Sponsor or person
Institute
The Japanese Institution for Standardizing Assisted Reproductive Technology (JISART)
Institute
Department
Personal name
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
mail@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
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
1148
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
No longer 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
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 01 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
| 2022 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 06 | Month | 01 | Day |
Last modified on
| 2023 | Year | 06 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042039
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