Tokyo, May 24 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061668) titled 'A clinical study aiming to improve fertility treatment outcomes by restoring the vaginal microbiome' on May 23.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -but assessor(s) are blinded Control - Active

Primary Sponsor: Institute - HORAC Grand Front Osaka Clinic (Sankeikai Medical Corporation)

Condition: Condition - Unexplained infertility with vaginal microbiome dysbiosis Classification by malignancy - Others Genomic information - NO

Objective: 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 = 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 Size - 60

Recruitment Status: 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

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070561

Disclaimer: Curated by HT Syndication.