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Efficacy of endometrial microbiome metagenomic analysis (EMMA)and analysis of infectious chronic endometritis (ALICE)

Efficacy of endometrial microbiome metagenomic analysis and analysis of infectious chronic endometritis - Efficacy of EMMA/ALICE

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000045730
Enrollment
150
Registered
2022-02-01
Start date
2022-04-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Repeated implantation failure, repeated pregnancy loss, chronic endometritis

Interventions

Suggest EMMA/ALICE test and perform the same for patients who requested the tests Explain the results to the study participants based on the test result reports, and validate subsequent tests and add

Sponsors

Kamiya ladies clinic
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1,Repeated implantation failure with no clinical pregnancy after two or more implantations. 2,Repeated miscarriages (two or more previous miscarriages) 3,Patients with difficult-to-treat cases of bacterial vaginosis 4, Patients suspected of having chronic endometritis by the hysteroscopy

Exclusion criteria

Exclusion criteria: Untreated Fallopian Tube Hydrops. Intrauterine lesions (endometrial polyps, submucosal fibroids, etc.) The patient has received antibiotics 3 months prior to the test. Have a serious medical condition.

Design outcomes

Primary

MeasureTime frame
Ongoing pregnancy rate; Comparison of ongoing pregnancy rates between the normal uterine microbiota group and the treatment intervention group (after treatment intervention for Lactobacillus <90%)

Secondary

MeasureTime frame
1,Detection of the percentage of patients with recurrent implantation failure, recurrent miscarriages, and patients suspected of CE by other tests whose intrauterine flora is actually dominated by pathogenic bacteria other than Lactobacillus species. 2,Impact on implantation rate and clinical pregnancy rate in patients with recurrent implantation failure and recurrent miscarriage after this test 3,Verify the concordance rate with vaginal culture and hysteroscopy. 4,Frequency of complications from the test such as pain, infection, uterine perforation, and vagus reflex

Countries

Japan

Contacts

Public ContactNanako Iwami

Kaimiya ladies clinic Reproductive health

nanakoiwami@gmail.com011-231-2722

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026