Can a vaginal bacteria capsule boost IVF success?
NCT ID NCT07453069
First seen Jun 26, 2026 · Last updated Sep 04, 2026 · Updated 3 times
Summary
This study tests a new treatment called FB301, a capsule containing beneficial bacteria, for women with an imbalance of vaginal bacteria who have had a failed frozen embryo transfer (IVF). Thirty women aged 18-40 will receive FB301 or a placebo during a mock IVF cycle, with some also receiving a vaginal cleanse. The goal is to see if FB301 can restore healthy bacteria levels and improve pregnancy outcomes in a subsequent real embryo transfer.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- FB301 (a capsule containing live bacteria) and chlorhexidine vaginal cleanse
- What this could lead to
- If successful, this could lead to a treatment that improves the vaginal bacterial balance, potentially increasing the chance of pregnancy after frozen embryo transfer.
- What could go wrong
- This is a small early-phase trial with only 30 participants, so results may not apply to everyone. The treatment may not improve pregnancy rates, and there is a risk of side effects from the vaginal cleanse or the bacteria.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2026
- Expected to finish
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Sep 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 40 years
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
4 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Boston IVF
NOT_YET_RECRUITINGWaltham, Massachusetts, 02451, United States
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Cypress Medical Research Centre
RECRUITINGWichita, Kansas, 67226, United States
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Delta Hy Research LLC / Advanced Fertility Texas
RECRUITINGHouston, Texas, 77079, United States
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REACH Fertility
NOT_YET_RECRUITINGCharlotte, North Carolina, 28207, United States
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