UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061668 |
|---|---|
| Receipt number | R000070561 |
| Scientific Title | A single-center, assessor-blinded, randomized controlled trial to evaluate the efficacy of a Lactobacillus-based oral formulation on vaginal microbiome restoration in women with unexplained infertility |
| Date of disclosure of the study information | 2026/05/23 |
| Last modified on | 2026/05/23 10:09:33 |
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Basic information
Public title
A clinical study aiming to improve fertility treatment outcomes by restoring the vaginal microbiome
Acronym
HORAC-VAGI Trial
Scientific Title
A single-center, assessor-blinded, randomized controlled trial to evaluate the efficacy of a Lactobacillus-based oral formulation on vaginal microbiome restoration in women with unexplained infertility
Scientific Title:Acronym
HORAC-VAGI Trial
Region
| Japan |
Condition
Condition
Unexplained infertility with vaginal microbiome dysbiosis
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of an orally administered probiotic formulation containing Lactobacillus crispatus, L. acidophilus, L. plantarum plus lactoferrin on vaginal microbiome restoration (Nugent score improvement and Lactobacillus proportion change) compared with standard care (vaginal douching plus intravaginal metronidazole) in women with unexplained infertility and vaginal dysbiosis (Nugent score >=7 or Lactobacillus dominance <30%). Differences between two daily doses (1 vs 2 capsules), cumulative pregnancy and miscarriage rates with assisted reproductive treatment, gut microbiome changes, and safety will also be assessed.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Vaginal microbiome improvement rate at 4 weeks after intervention initiation. Improvement is defined as either: (1) Nugent score reduction to <=6 in participants with baseline Nugent score >=7, or (2) an absolute increase of >=30% in Lactobacillus dominance from baseline as measured by vaginal microbiome sequencing.
Key secondary outcomes
(1) Recurrence rate of bacterial vaginosis (symptom-based), (2) cumulative ongoing pregnancy rate up to 6 months (confirmed at gestational week 9), (3) cumulative implantation rate up to 6 months, (4) miscarriage rate (before gestational week 22), (5) incidence and severity of adverse events (per CTCAE v5.0), (6) treatment compliance rate, (7) association between baseline characteristics (age, BMI) and treatment response, (8) gut microbiome compositional and functional changes by shotgun metagenomic sequencing, (9) changes in peripheral blood cytokine profile.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Standard care group. Participants receive vaginal douching and intravaginal metronidazole tablets per institutional protocol for the first 4 weeks. Standard fertility treatment (timed intercourse, intrauterine insemination, IVF, ICSI-ET) is continued throughout the intervention period. Observation continues for up to 6 months or until pregnancy confirmation, whichever comes first.
Interventions/Control_2
Oral 1T group. In addition to standard care, participants take one capsule per day of a probiotic formulation containing three Lactobacillus species (L. crispatus, L. acidophilus, L. plantarum) and lactoferrin, for up to 6 months or until pregnancy confirmation, whichever comes first. Standard fertility treatment is continued. Detailed strain identifiers and colony-forming unit (CFU) counts are not disclosed in this registration due to intellectual property protection and are documented in the IRB-approved protocol appendix.
Interventions/Control_3
Oral 2T group. In addition to standard care, participants take two capsules per day of the same probiotic formulation as in Intervention 2, for up to 6 months or until pregnancy confirmation, whichever comes first. Standard fertility treatment is continued.
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
| 18 | years-old | <= |
Age-upper limit
| 39 | years-old | >= |
Gender
Female
Key inclusion criteria
(1) Women aged 18-39 years; (2) failure to conceive after at least one year of regular unprotected intercourse; (3) no identifiable cause of infertility on baseline workup (uterine, ovarian, tubal, cervical, or male factor); (4) currently receiving fertility treatment at the participating institution; (5) Nugent score >7, OR Nugent score <7 with Lactobacillus dominance <30% on vaginal microbiome analysis; (6) written informed consent obtained; (7) able to attend all scheduled visits.
Key exclusion criteria
(1) Severe systemic disease (cardiac, hepatic, renal, inflammatory bowel disease, diabetes, etc.); (2) past or current malignancy; (3) past or current autoimmune disease; (4) current use of immunosuppressants or systemic corticosteroids; (5) use of antibiotics or probiotic preparations within the past month (eligible after 1-month washout); (6) known allergy to lactic acid bacteria; (7) psychiatric disorder precluding informed decision-making; (8) any other condition deemed inappropriate by the principal investigator.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Shinnosuke |
| Middle name | |
| Last name | Komiya |
Organization
HORAC Grand Front Osaka Clinic
Division name
Department of Reproductive Medicine
Zip code
530-0011
Address
Grand Front Osaka Tower B 15F, 3-1 Ofuka-cho, Kita-ku, Osaka, 530-0011, Japan
TEL
0663778824
komiya520@ivfjapan.com
Public contact
Name of contact person
| 1st name | Shinnosuke |
| Middle name | |
| Last name | Komiya |
Organization
HORAC Grand Front Osaka Clinic
Division name
Department of Reproductive Medicine / Research Office
Zip code
530-0011
Address
Grand Front Osaka Tower B 15F, 3-1 Ofuka-cho, Kita-ku, Osaka, 530-0011, Japan
TEL
08050644648
Homepage URL
komiya520@ivfjapan.com
Sponsor or person
Institute
HORAC Grand Front Osaka Clinic (Sankeikai Medical Corporation)
Institute
Department
Personal name
Funding Source
Organization
KINS Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
KINS Inc. (Provides vaginal microbiome DNA extraction kits, vaginal microbiome DNA sequencing and analysis, peripheral blood cytokine assay kits, the study product, clinical trial liability insurance, and gut microbiome analysis kits with shotgun metagenomic sequencing. KINS Inc. is not involved in the study design, data analysis, or publication processes; the scientific independence of the study is maintained.)
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Sankeikai Medical Corporation Ethics Committee
Address
Grand Front Osaka Tower B 15F, 3-1 Ofuka-cho, Kita-ku, Osaka, 530-0011, Japan
Tel
0663778824
komiya520@ivfjapan.com
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
HORACグランフロント大阪クリニック
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 05 | Month | 23 | 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
| 2026 | Year | 04 | Month | 10 | Day |
Date of IRB
| 2026 | Year | 05 | Month | 12 | Day |
Anticipated trial start date
| 2026 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 26 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a single-center pilot trial. Monthly safety monitoring is performed and a Data Safety Monitoring Committee is established. Detailed product composition (strain identifiers and CFU counts) is not disclosed in this registration under the intellectual property protection agreement with the collaborating partner; this information is documented in the IRB-approved protocol appendix (CMC information) and is accessible only to IRB members, auditors, and regulatory authorities.
Management information
Registered date
| 2026 | Year | 05 | Month | 23 | Day |
Last modified on
| 2026 | Year | 05 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070561
