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.
Able to understand the study and sign a consent form.
Is a woman aged 18 to 40 years.
Still has regular menstrual periods (pre-menopausal).
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.
History of three or more failed frozen embryo transfers (FET) in the past 3 years.
Have a condition that weakens the immune system (such as uncontrolled diabetes, active cancer, or an organ transplant).
Currently taking medications that suppress the immune system (such as systemic steroids, biologics, chemotherapy, or transplant medications).
Is already pregnant before completing the mock FET cycle.
Parallel
FB-301
DrugFB301 capsule
Placebo
DrugFB301 Placebo capsule
Chlorhexidine (0.5%) Vaginal Cleanse
Other interventionVaginal cleanse with 0.5% Chlorhexidine solution prior to first IP administration
Sham vaginal cleanse (saline)
Other interventionVaginal cleanse with saline solution prior to first IP administration.
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.
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.
Biochemical pregnancy rate following frozen embryo transfer (FET), defined as a positive serum beta-human chorionic gonadotropin (hCG) test.
Clinical pregnancy rate following frozen embryo transfer (FET), defined as the presence of a fetal heartbeat confirmed by transvaginal ultrasound.
Frequency and intensity of all treatment-emergent adverse events (TEAEs), adverse events (AEs), serious adverse events (SAEs), and adverse events of special interest) AESI
Click on the lead sponsor to view all of their trials.
Freya Biosciences ApS
Lead sponsor
Premier Research
Collaborator
