Effect of FB301 on Vaginal Bacterial Profile in Women With Asymptomatic Vaginal Dysbiosis Undergoing a Mock Frozen Embryo Transfer Cycle
Public ClinicalTrials.gov record NCT07453069. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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 18-45 Years of Age With Asymptomatic Vaginal Molecular Dysbiosis Planning to Undergo a Frozen Embryo Transfer (FET) Cycle
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 45 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 may 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 * Subsequently complete a mock FET cycle before proceeding with their planned frozen embryo transfer cycle Participants who become pregnant will be followed-up until birth.
Study identification
- NCT ID
- NCT07453069
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 30 participants
Conditions and interventions
Conditions
Interventions
- FB-301 Drug
- Placebo Drug
- Chlorhexidine (0.5%) Vaginal Cleanse Other
- Sham vaginal cleanse (saline) Other
Drug · Other
Eligibility (public fields only)
- Age range
- 18 Years to 45 Years
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 22, 2026 (Actual)
- Primary completion
- Oct 31, 2026 (Estimated)
- Completion
- Sep 30, 2027 (Estimated)
- Last update posted
- Oct 15, 2026
2026 – 2027
United States locations
- U.S. sites
- 4
- U.S. states
- 4
- U.S. cities
- 4
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Cypress Medical Research Centre | Wichita | Kansas | 67226 | Recruiting |
| Boston IVF | Waltham | Massachusetts | 02451 | Not yet recruiting |
| REACH Fertility | Charlotte | North Carolina | 28207 | Recruiting |
| Delta Hy Research LLC / Advanced Fertility Texas | Houston | Texas | 77079 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07453069, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 15, 2026 · Synced Oct 26, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT07453069 live on ClinicalTrials.gov.