UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058688 |
|---|---|
| Receipt number | R000066907 |
| Scientific Title | 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 |
| Date of disclosure of the study information | 2025/08/15 |
| Last modified on | 2025/08/13 15:29:55 |
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Basic information
Public title
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
Acronym
Screening for the Endometrial microbiome in Early Diagnosis of Infertility (SEED) study
Scientific Title
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
Scientific Title:Acronym
Screening for the Endometrial microbiome in Early Diagnosis of Infertility (SEED) study
Region
| Japan |
Condition
Condition
Infertility
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
YES
Objectives
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
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
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.
Key secondary outcomes
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)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
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.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 40 | 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 sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Yutaro |
| Middle name | |
| Last name | Mori |
Organization
Niigata University Medical and Dental Hospital
Division name
Department of Obstetrics and Gynecology
Zip code
951-8510
Address
1-757 Asahimachi-dori, Chuo-ku, Niigata City, Niigata 951-8510, Japan
TEL
0252272320
yutmori@med.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | Yutaro |
| Middle name | |
| Last name | Mori |
Organization
Niigata University Medical and Dental Hospital
Division name
Department of Obstetrics and Gynecology
Zip code
951-8520
Address
1-757 Asahimachi-dori, Chuo-ku, Niigata City, Niigata 951-8510, Japan
TEL
0252272320
Homepage URL
yutmori@med.niigata-u.ac.jp
Sponsor or person
Institute
Niigata University
Institute
Department
Personal name
Funding Source
Organization
Niigata University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Niigata University Medical and Dental Hospital
Address
1-757 Asahimachi-dori, Chuo-ku, Niigata City, Niigata 951-8510, Japan
Tel
0252272625
ethics@adm.niigata-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 08 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
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 |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 08 | Month | 04 | Day |
Last modified on
| 2025 | Year | 08 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066907
