Recruiting
Phase 2

FB301

Sponsor:

Freya Biosciences ApS

Code:

NCT07453069

Conditions

Vaginal Dysbiosis

Eligibility Criteria

Sex: Female

Age: 18 - 40

Healthy Volunteers: Not accepted

Interventions

FB-301

Placebo

Chlorhexidine (0.5%) Vaginal Cleanse

Sham vaginal cleanse (saline)

Study Details

Brief 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

Study ID

NCT07453069

Start date

Jul 22, 2026

Status verified date

Sep, 2026

Completion date

Sep 30, 2027

Anticipated

Primary completion date

Oct 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 40

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: FB301 / Chlorhexidine

experimental: FB301 / Sham

placebo comparator: Placebo / Sham

Interventions

FB-301

FB301 capsule

Placebo

FB301 Placebo capsule

Chlorhexidine (0.5%) Vaginal Cleanse

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

Sham vaginal cleanse (saline)

Vaginal cleanse with saline solution prior to first IP administration.

Primary outcome measure

  • 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. [ Time Frame: Baseline to Day 16 (Mock FET cycle) ]

Central Contacts and Locations

Locations

Cypress Medical Research Centre

Recruiting

Wichita, Kansas, United States, 67226

Contacts

Bryan S Baker, RN, MSM, CCRC

312 214 3690bryan@cypressmrc.com

Delta Hy Research LLC / Advanced Fertility Texas

Recruiting

Houston, Texas, United States, 77079

Contacts

More Information

Sponsor

Freya Biosciences ApS

Last update posted

Sep 3, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Freya Biosciences ApS on 2026-09-03.