An interventional study of postbiotics in Infertile Women Undergoing IVF or ICSI, sponsored by Kaohsiung Veterans General Hospital.. Completed at 1 site in Taiwan. Open to female participants aged 30 Years to 45 Years. Per ClinicalTrials.gov, last updated 2025-12-11.
Sponsored by Kaohsiung Veterans General Hospital. · Not applicable, Interventional, and Treatment
This study investigates the effects of postbiotic intervention on vaginal microbiota in infertile patients. Using a pre-post test design, we will enroll 15 women aged 30-45 years with at least two IVF failures. Participants will receive postbiotic intervention for 8 weeks. Vaginal secretion samples will be collected before and after treatment for 16S rRNA sequencing analysis to assess microbial composition, dominant species distribution, α-diversity index, and Lactobacillus content. Primary outcomes include changes in vaginal microbiota composition and diversity, alterations in Lactobacillus abundance, and pregnancy rates in subsequent IVF-FET cycles.
Background The demand for infertility treatment is increasing, with approximately 10-15% of couples of reproductive age experiencing varying degrees of fertility issues. Vaginal microbiota dysbiosis may be a significant factor contributing to infertility, and a healthy vaginal microbiota environment plays a crucial role in embryo implantation. This study aims to investigate the effects of postbiotic intervention on the vaginal microbiota of infertile patients by analyzing the vaginal microbiota before and after bacteriocin treatment to evaluate its effectiveness in improving the vaginal microbial environment.
Objective This study aims to investigate changes in vaginal microbiota before and after the use of postbiotic intervention.
Methods This study employs a pre-post test design, planning to enroll 15 women aged 30-45 years diagnosed with infertility with at least two IVF treatment failure. All subjects must be free from severe gynecological diseases, not using antibiotics or probiotics, and without acute vaginal infection symptoms. The study period is 8 weeks. Before intervention, baseline data collection will include complete medical history and infertility treatment records. During the first visit, vaginal secretion samples will be collected for vaginal microbiota assessment through 16S rRNA sequencing analysis, simultaneously measuring Lactobacillus content and microbial diversity. Subjects will then use postbiotic intervention continuously for 8 weeks. After treatment, a second sampling will be conducted to re-analyze the vaginal microbiota. The primary outcome measures include changes in microbial composition before and after use, including dominant species distribution, α-diversity index, and changes in Lactobacillus content. All specimens will be collected, transported, and preserved following standard operating procedures to ensure testing quality. Research data will be analyzed using paired sample statistical methods to assess pre-post treatment differences, with significance level set at p\<0.05.
Outcome
2,506 studies on the registry are indexed under Infertility; 407 are open to participants now.
This study's enrollment of 15 is below the median of 120 across 1,698 interventional studies indexed under Infertility.
Browse Infertility studies →Kaohsiung Veterans General Hospital. is the lead sponsor of 102 studies on the registry; 12 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Other: postbiotics
Participants will self-administer postbiotic intervention via intravaginal suppositories containing purified bacteriocin peptides . The intervention consists of one suppository administered intravaginally at bedtime, once daily for 8 consecutive weeks (56 days total). Each suppository contains a standardized concentration of bacteriocins extracted from Lactobacillus strains.
Vaginal microbiome composition (genus level)
Changes in vaginal bacterial community structure assessed through 16S rRNA gene sequencing of vaginal secretion samples collected at baseline (Week 0) and post-intervention (Week 8)
Time frame: Baseline (Week 0) and post-intervention (Week 8)
Taxonomic abundance (%)
Quantitative measurement of the relative proportions of bacterial taxa at different taxonomic levels (phylum, genus, and species) in vaginal samples before and after bacteriocin treatment. Results will report the percentage abundance of major bacterial groups.
Time frame: Baseline (Week 0) and post-intervention (Week 8)
Pregnancy rate (%)
Visualization of fetal cardiac activity on transvaginal ultrasound at 6-7 weeks' gestation
Time frame: through study completion, an average of 8 months
Plan to share: No
This study is completed, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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Kaohsiung Veterans General Hospital.