MedTrace Logo

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

NCT07453069 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-03-05

No results posted yet for this study

Summary

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.

Conditions

  • Vaginal Dysbiosis

Interventions

DRUG

FB-301

FB301 capsule

DRUG

Placebo

FB301 Placebo capsule

OTHER

Chlorhexidine (0.5%) Vaginal Cleanse

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

OTHER

Sham vaginal cleanse (saline)

Vaginal cleanse with saline solution prior to first IP administration.

Sponsors & Collaborators

  • Premier Research

    collaborator OTHER

  • Freya Biosciences ApS

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-15
Primary Completion
2026-10-31
Completion
2027-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07453069 on ClinicalTrials.gov