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NCT07453069ClinicalTrials.gov

Effect of FB301 on Vaginal Bacterial Profile in Women With Asymptomatic Vaginal Dysbiosis Undergoing a Mock Frozen Embryo Transfer Cycle

A Randomized, Double-blind, Three Arm, Multi-center Phase 2 Study to Investigate the Molecular Efficacy and Safety of FB301/Chlorhexidine Compared With FB301/Sham and Placebo/Sham in a Mock FET Cycle in Female Participants 18-40 Years of Age With Asymptomatic Vaginal Molecular Dysbiosis Planning to Undergo a Frozen Embryo Transfer (FET) Cycle

En recrutementAccepte des participants actuellement, selon la fiche du registre.
Contacter cette étude

En bref

The goal of this clinical trial is to evaluate FB301 during a mock frozen embryo transfer (FET) cycle in pre-menopausal women aged 18 to 40 years with a prior failed FET and a defined vaginal bacterial imbalance (dysbiosis). The main…

Phase 230 participants recherchés4 sites1 pays

Catégories

Obstétrique et gynécologie73%Maladies infectieuses22%Endocrinien et métabolique4%

Enregistré dans 1 registre

Une même étude peut être enregistrée dans plusieurs registres. Nous l'affichons une seule fois et renvoyons vers chaque fiche que nous détenons.

Les informations de l'essai sont affichées telles que publiées par le registre, dans leur langue d'origine.

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How this study is set up

The points below are drawn from the public registry record for this study. Each one cites the field or sentence it came from. A dash (—) means the record does not state something — not that it is missing or wrong. Many well-run studies, especially small ones, leave some of these blank.

  • Registered before enrolment beganFirst posted 2026-03-05; recorded start 2026-07-22
  • Has a defined primary outcomeA primary outcome measure is listed in the record
  • The primary outcome states a time frameThe primary outcome measure records a time frame
  • Participants are randomly assignedAllocation is recorded as randomised
  • Has a comparison groupThe record lists a placebo or comparator arm, or more than one study arm
  • Uses blinding (masking)A masking level is recorded in the record
  • An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
  • Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
  • A data monitoring committee is not stated in the registry recordThis registry's ingested record has no data-monitoring-committee fieldA data monitoring committee is not required for many smaller studies, and its absence here is not unusual.
  • No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
  • Sponsor has 3 other studies in this databaseCounted from the lead sponsor named in the record (Freya Biosciences ApS)
  • No posted results from this sponsor are in this database yetBased on the sponsor’s studies in this database
  • The record lists 1 condition.
  • Lead sponsor type recorded as: industry.
  • Intervention regulatory context: investigational, within a phased regulatory pathway.

These are facts from the public registry record, not a judgement about the study. Discuss any trial with your own doctor before taking part.

What these facts mean, and what to ask · ruleset v1

Trial stature

Three independent measures of this study, described from its registry record — not a recommendation about it. A rigorous study by investigators nobody has heard of is better evidence than a weak study led by a famous one. How these are scored.

Methodological rigourSTRONG

A strong methodological design for a phase 2 study, judged from its ClinicalTrials.gov record.

How this score is built
  • Randomised allocation20/20

    Participants are randomly allocated between arms

  • Blinding16/20

    Triple-blind

  • Control arm13/15

    Placebo / sham control arm

  • Primary-outcome specificity10/10

    Named primary outcome with a defined time frame

  • Endpoint type3/10

    Surrogate or intermediate endpoint (conservative default)

  • Multi-centre0/8

    Single site, or site count not stated

  • Data monitoring committee7/7

    A data monitoring committee is in place

  • Prospective registration5/5

    Registered before the study start date

  • Protocol / SAP posted0/5

    No protocol or SAP posted to the registry

ScaleSMALL

A small study: 30 participants (target), run at 4 sites.

How this score is built
  • Enrolment12/40

    30 participants (target)

  • Site count0/25

    1 sites

  • Country count0/15

    Single country

  • Planned duration6/10

    Planned over about 18 months

  • Sponsor scale2/10

    Freya Biosciences ApS has led 4 trials in our corpus

Investigator standingUNKNOWN

We have no verifiable track record for the investigator named on this trial. That is common for early-career investigators and for records held outside ClinicalTrials.gov — it is not a negative signal.

How this score is built
  • Investigator standing0/100

    No investigator recorded in the registry for this trial

These describe the registry record only, and today we hold ClinicalTrials.gov data. Absent fields lower a score, and absence often reflects registration practice rather than study quality. A high-stature trial is not necessarily safer or a better choice for you — enrolling in a large definitive trial can mean a higher chance of receiving placebo, while a small early-phase study may be the only route to a new therapy.

Résumé

The goal of this clinical trial is to evaluate FB301 during a mock frozen embryo transfer (FET) cycle in pre-menopausal women aged 18 to 40 years with a prior failed FET and a defined vaginal bacterial imbalance (dysbiosis). The main question it aims to answer is: • Does treatment with FB301 during a mock FET cycle change the proportion of participants who meet the predefined vaginal bacterial threshold compared with placebo? Researchers will compare: * FB301 given after an initial vaginal cleansing with chlorhexidine (an antiseptic solution), * FB301 given after an initial vaginal cleansing with saline (saltwater), and * A placebo capsule given after an initial vaginal cleansing with saline to determine whether these approaches affect vaginal bacterial composition and pregnancy outcomes. Participants will take study treatment for 15 days during a "mock" FET cycle. In a mock cycle, participants receive the hormones needed to prepare the uterus for embryo transfer, but no embryo is transferred. After completing the mock cycle, participants will proceed with their planned frozen embryo transfer and will be followed during pregnancy until birth. Participants will: * Undergo a vaginal cleansing before receiving the first dose of FB301 or placebo * Provide vaginal swab samples at up to 5 study visits * Attend the study centre for up to 8 visits and participate in up to 4 follow-up phone calls * Complete a mock FET cycle before proceeding with their planned frozen embryo transfer cycle Participants who become pregnant will be followed until birth.

Vaginal dysbiosis characterized by reduced relative abundance of Lactobacillus species has been associated with reproductive outcomes in women undergoing frozen embryo transfer (FET). This study evaluates the safety, tolerability, and molecular effects of FB301 in women undergoing FET who have no known underlying clinical gynecological conditions but are identified as having molecular dysbiosis by metagenomic sequencing of a vaginal swab collected at screening. Participants will be randomized to one of three arms: (1) FB301 following a single initial vaginal cleansing with chlorhexidine (an antiseptic solution), (2) FB301 following a single sham cleansing with saline, or (3) placebo following sham cleansing. Cleansing occurs once prior to initiation of study treatment. Participants will then receive 15 days of study treatment during a mock frozen embryo transfer (FET) cycle in which participants receive hormonal preparation of the endometrium but no embryo is transferred. Following completion of the mock cycle, participants will proceed with their planned frozen embryo transfer during the subsequent menstrual cycle, in accordance with standard clinical practice. Participants who become pregnant will be followed until birth. The primary objective is to evaluate whether treatment increases the proportion of participants achieving a predefined Lactobacillus-dominant vaginal bacterial profile following therapy. Secondary objectives include evaluation of biochemical pregnancy (confirmed by serum beta-hCG testing) and clinical pregnancy (confirmed by transvaginal ultrasound) following the subsequent planned FET cycle.

Affections

  • Vaginal Dysbiosis

Éligibilité

SexeFemme
Âges18 Years – 40 Years
Volontaires sainsNon

Éligibilité telle qu'elle figure dans le registre

Inclusion Criteria: 1. Able to understand the study and sign a consent form. 2. Is a woman aged 18 to 40 years. 3. Still has regular menstrual periods (pre-menopausal). 4. Has had at least one previous frozen embryo transfer (FET) that did not result in pregnancy within the past 3 years, and this was not due to either male infertility or blocked /damaged fallopian tubes. 5. Planning to have a frozen embryo transfer (FET) using one good-quality embryo (grade 3BB or higher) and are considered medically suitable to proceed. 6. Willing to have only one embryo transferred during the study cycle. 7. A vaginal swab taken at the first study visit shows a specific vaginal microbiome imbalance required for this study (vaginal molecular dysbiosis). 8. An ultrasound scan shows no problems with uterus or pelvis that would prevent pregnancy or greatly reduce the chance of pregnancy. 9. Recent fertility blood tests (within the last 6 months) show: * FSH less than 12 IU/L * AMH greater than 1 ng/mL 10. Body mass index (BMI) is between 18 and 38 kg/m². 11. From the first study treatment until the mock FET cycle, agrees to: * Avoid vaginal intercourse or use condoms (without spermicide or lubricant), * Avoid swimming or hot tubs, * Avoid using tampons, menstrual cups, sex toys, vaginal cleansers, lubricants, or other vaginal products unless approved by the study team. 12. Willing to answer questions about sexual and reproductive activity during the study. 13. Willing to provide vaginal swab samples at the clinic. 14. Willing to receive the first study treatment in the clinic and use the study treatment at home as instructed. 15. Screening blood tests are negative for hepatitis B, hepatitis C, HIV, and syphilis. 16. Willing to attend all study visits and follow-up assessments and provide information about pregnancy and newborn health outcomes. Exclusion Criteria: 1. History of three or more failed frozen embryo transfers (FET) in the past 3 years. 2. Have a condition that weakens the immune system (such as uncontrolled diabetes, active cancer, or an organ transplant). 3. Currently taking medications that suppress the immune system (such as systemic steroids, biologics, chemotherapy, or transplant medications). 4. Is already pregnant before completing the mock FET cycle. 5. Test positive for a sexually transmitted infection (such as chlamydia, gonorrhea, Mycoplasma genitalium, or Trichomonas vaginalis). 6. Current vaginal yeast infection that requires treatment. 7. YCannot safely take the hormone medications required for a frozen embryo transfer (such as estradiol or progesterone). 8. Use of intravaginal progesterone gels or solutions. 9. Needs regular antibiotics or are likely to require antibiotics during the study. 10. Has taken oral, injectable, or vaginal antibiotics within 30 days before screening. 11. History of gynecological cancer or other significant gynecological condition that would make participation unsafe. 12. Has a medical condition that would make participation unsafe or difficult. 13. Has an unstable medical or psychiatric condition that could make it difficult to follow study requirements. 14. Has any other condition that could interfere with participation.

Éligibilité en énoncés simples

Les critères de cette fiche n'ont pas encore été décomposés en énoncés distincts. Le texte du registre ci-dessus est complet et fait foi.

Conception de l'étude

Type d'étudeInterventionnelle
PhasePhase 2
RépartitionRandomisée
Modèle d'interventionPARALLEL
Objectif principalTREATMENT
InsuTRIPLE (3)
Recrutement30 participants recherchés

Promoteur et collaborateurs

  • Freya Biosciences ApS Promoteur
  • Premier Research Collaborateurs

Groupes et interventions

  • FB301 / ChlorhexidineEXPERIMENTAL
  • FB301 / ShamEXPERIMENTAL
  • Placebo / ShamPLACEBO_COMPARATOR

Interventions

  • Autre Chlorhexidine (0.5%) Vaginal Cleanse

    Vaginal cleanse with 0.5% Chlorhexidine solution prior to first IP administration

  • Médicament FB-301

    FB301 capsule

  • Médicament Placebo

    FB301 Placebo capsule

  • Autre Sham vaginal cleanse (saline)

    Vaginal cleanse with saline solution prior to first IP administration.

Critères de jugement

  1. Critère de jugement principal

    Proportion of participants with ≥90% combined relative abundance of Lactobacillus crispatus, L. jensenii, L. mulieris, L. gasseri, and L. paragasseri as measured by metagenomic sequencing.

    Metagenomic sequencing is performed on cervical vaginal swab samples. Relative abundance is expressed as a percentage of bacterial sequencing reads that are assigned to a specific bacterial species.

    Délai Baseline to Day 16 (Mock FET cycle)

  2. Critère de jugement secondaire

    Percentage change from baseline in relative abundance of Lactobacillus crispatus, L. jensenii, L. mulieris, L. gasseri, and L. paragasseri as measured by metagenomic sequencing.

    Metagenomic sequencing is performed on cervical vaginal swab samples. Relative abundance is expressed as a percentage of bacterial sequencing reads that are assigned to a specific bacterial species.

    Délai Baseline to Day 16 (Mock FET cycle)

  3. Critère de jugement secondaire

    Biochemical pregnancy rate following frozen embryo transfer (FET), defined as a positive serum beta-human chorionic gonadotropin (hCG) test.

    Délai 12-14 days after frozen embryo transfer (FET)

  4. Critère de jugement secondaire

    Clinical pregnancy rate following frozen embryo transfer (FET), defined as the presence of a fetal heartbeat confirmed by transvaginal ultrasound.

    Délai 5-6 weeks after frozen embryo transfer (FET)

  5. Critère de jugement secondaire

    Frequency and intensity of all treatment-emergent adverse events (TEAEs), adverse events (AEs), serious adverse events (SAEs), and adverse events of special interest) AESI

    Délai Baseline to End of Study (up to neonatal follow-up assessment (Visit 11), approximately 10 months after FET)

  6. Critère de jugement secondaire

    The incidence of early pregnancy loss, defined as a positive beta-hCG test (biochemical pregnancy) at 12-14 days after FET but no transvaginal ultrasound-confirmed fetal heartbeat at 5-6 weeks after FET (Visit 7)

    Délai 5-6 weeks after FET

Dates

Date de début22 juillet 2026 (réelle)
Achèvement principal31 octobre 2026 (estimée)
Achèvement30 septembre 2027 (estimée)
Première publication5 mars 2026 (réelle)
Dernière mise à jour3 septembre 2026
Résultats publiésNon précisé dans la fiche du registre
Statut vérifié pour la dernière foisseptembre 2026

Réelle signifie que l'événement a eu lieu. Estimée signifie que le promoteur s'y attend. Les deux ont un sens différent.

Lieux

2 sites sont en recrutement

United States

ÉtablissementVilleÉtat ou régionStatut
REACH FertilityCharlotteNorth CarolinaPas encore en recrutement
Delta Hy Research LLC / Advanced Fertility TexasHoustonTexasEn recrutement
Boston IVFWalthamMassachusettsPas encore en recrutement
Cypress Medical Research CentreWichitaKansasEn recrutement

Documents de l'étude

Aucun document n'est lié dans cette fiche du registre.

Évolution au fil du temps

  1. 3 septembre 2026

    Statut modifié

    Status changed from Not yet recruiting to Recruiting

    NOT_YET_RECRUITINGRECRUITING

  2. 3 septembre 2026

    Recrutement ouvert

    Recruitment opened

    NOT_YET_RECRUITINGRECRUITING

  3. 3 septembre 2026

    Site ajouté

    3 sites added (4 total)

    14

Registre: ClinicalTrials.gov · NCT########

https://xmedica.io/trials/ctgov/NCT07453069