Postbiotic Intervention on Vaginal Microbiota

NCT07278024 | Completed

• 1 other identifier: KSVGH25-CT1-18
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Infertile Women Undergoing IVF or ICSI

Keywords

vaginal microbiome; postbiotics; antimicrobial peptides; infertility; assisted reproductive technology; in vitro fertilization

Outcome Measures

Primary Outcomes (1)

• 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)

  Baseline (Week 0) and post-intervention (Week 8)

Secondary Outcomes (1)

• Taxonomic abundance (%)

  Baseline (Week 0) and post-intervention (Week 8)

Other Outcomes (1)

• Pregnancy rate (%)

  through study completion, an average of 8 months

Study Arms (1)

postbiotics

EXPERIMENTAL

Other: postbiotics

Interventions

postbiotics OTHER

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.

postbiotics

Eligibility Criteria

• Age: 30 Years - 45 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• (1) age 30-45 years;
• (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

You may not qualify if:

• (1) active acute vaginal infection with symptomatic presentation;
• (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

Sponsors & Collaborators

• Kaohsiung Veterans General Hospital.: lead

Study Sites (1)

Department of Obstetrics and Gynecology, Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan

Kaohsiung City, Taiwan

Location

Related Publications (13)

• 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.

  PMID: 39335866 BACKGROUND

• Vinderola G, Sanders ME, Salminen S. The Concept of Postbiotics. Foods. 2022 Apr 8;11(8):1077. doi: 10.3390/foods11081077.

  PMID: 35454664 BACKGROUND

• 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.

  PMID: 33948025 BACKGROUND

• 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.

  PMID: 34980280 BACKGROUND

• 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.

  PMID: 39868783 BACKGROUND

• 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.

  PMID: 34053157 BACKGROUND

• 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.

  PMID: 39045277 BACKGROUND

• 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.

  PMID: 39198832 BACKGROUND

• 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.

  PMID: 37882794 BACKGROUND

• 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.

  PMID: 26864580 BACKGROUND

• 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.

  PMID: 38203793 BACKGROUND

• 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.

  PMID: 31119299 BACKGROUND

• 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.

  PMID: 27717732 BACKGROUND

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending doctor, Department of Obstetrics and Gynecology

Study Record Dates

• First Submitted: November 30, 2025
• First Posted: December 11, 2025
• Study Start: April 1, 2025
• Primary Completion: July 31, 2025
• Study Completion: November 30, 2025
• Last Updated: December 11, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)