Study Results
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Basic Information
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COMPLETED
NA
15 participants
INTERVENTIONAL
2025-04-01
2025-11-30
Brief Summary
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Detailed Description
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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
1. Compare differences in vaginal microbiota before and after using postbiotic intervention.
2. Compare differences in taxonomic abundance before and after using postbiotic intervention.
3. Check pregnancy rate of IVF-FET cycle after postbiotic intervention use
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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postbiotics
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* (2) body mass index 18-30 kg/m²;
* (3) history of ≥2 prior IVF treatment failures despite transfer of good-quality embryos;
* (4) planned FET cycle;
* (5) willingness to comply with the eight-week postbiotic intervention protocol
Exclusion Criteria
* (2) antibiotic or probiotic use within the preceding three months;
* (3) congenital uterine anomalies including septate, bicornuate, or unicornuate uterus;
* (4) severe intrauterine adhesions (Asherman syndrome grade III-IV);
* (5) history of gynecologic malignancy;
* (6) known allergy or hypersensitivity to Lactobacillus-derived products;
* (7) current ongoing pregnancy
30 Years
45 Years
FEMALE
No
Sponsors
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Kaohsiung Veterans General Hospital.
OTHER
Responsible Party
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Li-Te Lin
Attending doctor, Department of Obstetrics and Gynecology
Locations
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Department of Obstetrics and Gynecology, Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan
Kaohsiung City, , Taiwan
Countries
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References
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Kumar A, Green KM, Rawat M. A Comprehensive Overview of Postbiotics with a Special Focus on Discovery Techniques and Clinical Applications. Foods. 2024 Sep 17;13(18):2937. doi: 10.3390/foods13182937.
Vinderola G, Sanders ME, Salminen S. The Concept of Postbiotics. Foods. 2022 Apr 8;11(8):1077. doi: 10.3390/foods11081077.
Salminen S, Collado MC, Endo A, Hill C, Lebeer S, Quigley EMM, Sanders ME, Shamir R, Swann JR, Szajewska H, Vinderola G. The International Scientific Association of Probiotics and Prebiotics (ISAPP) consensus statement on the definition and scope of postbiotics. Nat Rev Gastroenterol Hepatol. 2021 Sep;18(9):649-667. doi: 10.1038/s41575-021-00440-6. Epub 2021 May 4.
Moreno I, Garcia-Grau I, Perez-Villaroya D, Gonzalez-Monfort M, Bahceci M, Barrionuevo MJ, Taguchi S, Puente E, Dimattina M, Lim MW, Meneghini G, Aubuchon M, Leondires M, Izquierdo A, Perez-Olgiati M, Chavez A, Seethram K, Bau D, Gomez C, Valbuena D, Vilella F, Simon C. Endometrial microbiota composition is associated with reproductive outcome in infertile patients. Microbiome. 2022 Jan 4;10(1):1. doi: 10.1186/s40168-021-01184-w.
Zhao H, Wang C, Narsing Rao MP, Rafiq M, Luo G, Li S, Kang Y-Q. Effects of vaginal microbiota on in vitro fertilization outcomes in women with different infertility causes. Microbiol Spectr. 2025 Mar 4;13(3):e0125524. doi: 10.1128/spectrum.01255-24. Epub 2025 Jan 27.
Karaer A, Dogan B, Gunal S, Tuncay G, Arda Duz S, Unver T, Tecellioglu N. The vaginal microbiota composition of women undergoing assisted reproduction: a prospective cohort study. BJOG. 2021 Dec;128(13):2101-2109. doi: 10.1111/1471-0528.16782. Epub 2021 Jun 20.
Tian Q, Jin S, Zhang G, Liu Y, Liu J, Tang X, Li Y, Liu J, Liu Y, Wang Z. Assessing vaginal microbiome through Vaginal Microecology Evaluation System as a predictor for in vitro fertilization outcomes: a retrospective study. Front Endocrinol (Lausanne). 2024 Jul 9;15:1380187. doi: 10.3389/fendo.2024.1380187. eCollection 2024.
Su W, Gong C, Zhong H, Yang H, Chen Y, Wu X, Jin J, Xi H, Zhao J. Vaginal and endometrial microbiome dysbiosis associated with adverse embryo transfer outcomes. Reprod Biol Endocrinol. 2024 Aug 28;22(1):111. doi: 10.1186/s12958-024-01274-y.
Vainamo S, Saqib S, Kalliala I, Kervinen K, Luiro K, Niinimaki M, Halttunen-Nieminen M, Virtanen S, Nieminen P, Salonen A, Holster T. Longitudinal analysis of vaginal microbiota during IVF fresh embryo transfer and in early pregnancy. Microbiol Spectr. 2023 Dec 12;11(6):e0165023. doi: 10.1128/spectrum.01650-23. Epub 2023 Oct 26.
Onderdonk AB, Delaney ML, Fichorova RN. The Human Microbiome during Bacterial Vaginosis. Clin Microbiol Rev. 2016 Apr;29(2):223-38. doi: 10.1128/CMR.00075-15.
Gao X, Louwers YV, Laven JSE, Schoenmakers S. Clinical Relevance of Vaginal and Endometrial Microbiome Investigation in Women with Repeated Implantation Failure and Recurrent Pregnancy Loss. Int J Mol Sci. 2024 Jan 3;25(1):622. doi: 10.3390/ijms25010622.
Koedooder R, Singer M, Schoenmakers S, Savelkoul PHM, Morre SA, de Jonge JD, Poort L, Cuypers WJSS, Beckers NGM, Broekmans FJM, Cohlen BJ, den Hartog JE, Fleischer K, Lambalk CB, Smeenk JMJS, Budding AE, Laven JSE. The vaginal microbiome as a predictor for outcome of in vitro fertilization with or without intracytoplasmic sperm injection: a prospective study. Hum Reprod. 2019 Jun 4;34(6):1042-1054. doi: 10.1093/humrep/dez065.
Moreno I, Codoner FM, Vilella F, Valbuena D, Martinez-Blanch JF, Jimenez-Almazan J, Alonso R, Alama P, Remohi J, Pellicer A, Ramon D, Simon C. Evidence that the endometrial microbiota has an effect on implantation success or failure. Am J Obstet Gynecol. 2016 Dec;215(6):684-703. doi: 10.1016/j.ajog.2016.09.075. Epub 2016 Oct 4.
Other Identifiers
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KSVGH25-CT1-18
Identifier Type: -
Identifier Source: org_study_id
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