Screening for the Endometrial microbiome in Early Diagnosis of Infertility (SEED) study: A multicenter interventional trial to evaluate the efficacy of EMMA/ALICE as an initial screening test in infertility treatment

Screening for the Endometrial microbiome in Early Diagnosis of Infertility (SEED) study: A multicenter interventional trial to evaluate the efficacy of EMMA/ALICE as an initial screening test in infertility treatment - Screening for the Endometrial microbiome in Early Diagnosis of Infertility (SEED) study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000058688

Enrollment

200

Registered

2025-08-15

Start date

2025-08-18

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

Infertility

Interventions

Name: EMMA/ALICE testing + treatment based on test results (antibiotics or probiotics) Details: As an initial screening during infertility treatment, an endometrial biopsy is performed and subjec

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: Patients diagnosed with infertility and planning to undergo timed intercourse or intrauterine insemination (IUI) Female patients aged 20 years or older and younger than 40 years Patients who provide written informed consent

Exclusion criteria

Exclusion criteria: Patients with a history of in vitro fertilization (IVF) treatment at another institution Patients diagnosed with recurrent implantation failure or recurrent miscarriage Patients with severe uterine anomalies Couples with infertility primarily due to male factors Patients with uterine conditions requiring surgical treatment (e.g., submucosal fibroids, endometrial polyps, Asherman's syndrome, cesarean scar syndrome) Patients with untreated hydrosalpinx Patients with antibiotic allergies that preclude standard treatment Patients requiring ongoing antibiotic treatment for other medical conditions Patients with unstable medical conditions or those deemed unable to comply with the study protocol Patients deemed inappropriate for participation by the principal investigator or attending physician

Design outcomes

Primary

Measure	Time frame
Clinical pregnancy rate up to gestational sac confirmation To evaluate the efficacy of EMMA/ALICE testing by comparing the clinical pregnancy rate (confirmation of gestational sac) between the tested and non-tested groups.	—

Secondary

Measure	Time frame
1. Miscarriage rate (rate of clinical miscarriage after conception) 2. Preterm birth rate (rate of delivery before 37 weeks of gestation) 3. Live birth rate (rate of confirmed live births) 4. Time to Pregnancy (TTP): duration from initiation of treatment to confirmed pregnancy 5. Safety of EMMA/ALICE testing and treatment (incidence and severity of adverse events)	—

Countries

Japan

Contacts

Public ContactYutaro Mori

Niigata University Medical and Dental Hospital Department of Obstetrics and Gynecology

yutmori@med.niigata-u.ac.jp0252272320

Outcome results

None listed

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