Efficacy evaluation study for EMMA and ALICE test in multi-centers. A joint research with Japanese Institution for Standardizing Assisted Reproductive Technology (JISART)

Phase 2

Completed

• Conditions: Infectious Chronic Endometritis

• Registration Number: JPRN-UMIN000036917
• Lead Sponsor: The Japanese Institution for Standardizing Assisted Reproductive Technology (JISART)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-06-01
• Study Completion: 2022-12-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up continuing
• Sex: Female
• Target Recruitment: 1148

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
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.