Unexplained infertility with vaginal microbiome dysbiosis
Conditions
Interventions
Standard care group. Participants receive vaginal douching and intravaginal metronidazole tablets per institutional protocol for the first 4 weeks. Standard fertility treatment (timed intercourse, int
Sponsors
HORAC Grand Front Osaka Clinic (Sankeikai Medical Corporation)
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.)
Eligibility
Sex/Gender
Female
Inclusion criteria
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.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| (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. | — |
Countries
Japan
Contacts
Public ContactShinnosuke Komiya
HORAC Grand Front Osaka Clinic Department of Reproductive Medicine / Research Office
Outcome results
None listed