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 |
Efficacy evaluation study for EMMA and ALICE test in multi-centers.
A joint research with Japanese Institution for Standardizing Assisted Reproductive Technology (JISART)
EMMA/ALICE efficacy evaluation
Efficacy evaluation study for EMMA and ALICE test in multi-centers.
A joint research with Japanese Institution for Standardizing Assisted Reproductive Technology (JISART)
EMMA/ALICE efficacy evaluation
Japan |
Infectious Chronic Endometritis
Obstetrics and Gynecology |
Others
NO
To improve pregnancy rate and ongoing pregnancy rate and decrease miscarriage rate of IVF treatments using EMMA/ALICE.
Efficacy
Confirmatory
Pragmatic
Phase II,III
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.
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.
Interventional
Parallel
Non-randomized
Open -no one is blinded
No treatment
2
Prevention
Device,equipment |
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).
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.
20 | years-old | <= |
40 | years-old | >= |
Female
1, Patients undergoing ART treatments in JISART registered institutions, with scheduled embryo implantation
2, Patients who can perform re-examination if necessary
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.
500
1st name | Hirobumi |
Middle name | |
Last name | Kamiya |
Kamiya Ladies Clinic
Reproductive Center
060003
Nittsu-Sapporo Bldg 2F 2-1 Nishi 2-chome Kita 3-Jo Chuo-ku, Sapporo 060-0003 Japan
0112312722
kamiya@fine.ocn.ne.jp
1st name | Rie |
Middle name | |
Last name | HIrokawa |
The Japanese Institution for Standardizing Assisted Reproductive Technology (JISART)
Reproductive Health
5300002
MF Sakurabashi Bldg 5F 2-6-23 Shinchi Sonesaki Kita-Ku Osaka 5300002 Japan
0661319741
hirokawa@jisart.jp
The Japanese Institution for Standardizing Assisted Reproductive Technology (JISART)
Igenomix Japan K.K.
Profit organization
IRB at the Japanese Institution for Standardizing Assisted Reproductive Technology (JISART)
MF Sakurabashi Bldg 5F 2-6-23 Shinchi Sonesaki Kita-Ku Osaka 5300002 Japan
0661319741
mail@jisart.jp
NO
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)
2019 | Year | 06 | Month | 01 | Day |
Partially published
1148
No longer recruiting
2019 | Year | 01 | Month | 10 | Day |
2019 | Year | 01 | Month | 08 | Day |
2019 | Year | 06 | Month | 01 | Day |
2022 | Year | 12 | Month | 31 | Day |
2023 | Year | 01 | Month | 31 | Day |
2022 | Year | 12 | Month | 31 | Day |
2019 | Year | 06 | Month | 01 | Day |
2023 | Year | 06 | Month | 06 | Day |
Value
https://center6.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 |