Tokyo, Aug. 15 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058688) titled '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' on Aug. 15.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Non-randomized Blinding - Open -no one is blinded Control - No treatment

Primary Sponsor: Institute - Niigata University

Condition: Condition - Infertility Classification by malignancy - Others Genomic information - YES

Objective: Narrative objectives1 - The objective of this study is to evaluate whether the introduction of intrauterine microbiome testing (EMMA/ALICE) at an early stage of infertility treatment can improve pregnancy and live birth rates in patients undergoing timed intercourse or intrauterine insemination, by enabling early detection of uterine microbial abnormalities and appropriate therapeutic interventions. In addition, multi-omics analysis of surplus endometrial samples obtained during testing will be conducted to identify novel molecular markers associated with implantation and pregnancy maintenance. Basic objectives2 - Safety

Intervention: Interventions/Control_1 - 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 subjected to EMMA/ALICE testing (Real-Time PCR-based endometrial microbiome analysis). If abnormalities are detected, treatment is provided using recommended antibiotics or high-concentration Lactobacillus crispatus probiotics. Patients then proceed with timed intercourse or intrauterine insemination (IUI). Primary and secondary outcomes include clinical pregnancy rate, miscarriage rate, live birth rate, and time to pregnancy (TTP).

Duration/Frequency: Testing is conducted once. Treatment, if indicated, lasts approximately 2-4 weeks (antibiotics) or 15-30 days (probiotics). Retesting is optional upon patient request. Patients are followed for up to 2 years or until pregnancy is achieved. Interventions/Control_2 - Name: Standard infertility treatment (timed intercourse or intrauterine insemination)

Details: EMMA/ALICE testing is not performed as part of the initial infertility evaluation. Patients undergo standard fertility treatment based on clinical judgment, including timed intercourse or intrauterine insemination (IUI). No antibiotic or probiotic treatment based on endometrial microbiome testing is administered. Observational outcomes include clinical pregnancy rate, miscarriage rate, live birth rate, and time to pregnancy (TTP).

Duration/Frequency: Patients are followed until pregnancy is achieved or treatment is completed, up to a maximum of 2 years. Fertility treatment is conducted according to standard treatment cycles.

Eligibility: Age-lower limit - 20 years-old

Gender - Female Key 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 Key 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 Target Size - 200

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 06 Month 03 Day Date of IRB - 2025 Year 06 Month 04 Day Anticipated trial start date - 2025 Year 08 Month 18 Day Last follow-up date - 2028 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066907

Disclaimer: Curated by HT Syndication.