Do vaginal probiotic supplements improve pregnancy outcomes in women having frozen embryo transfer?

Vaginal Probiotic Supplementation and Outcomes in Women Undergoing Frozen Embryo Transfer Cycles: A Randomised, Double-Blinded, Placebo-Controlled Trial

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12626000676314

Enrollment

Registered

2026-06-05

Start date

2026-09-01

Completion date

2027-01-01

Last updated

2026-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study will investigate whether vaginal probiotic supplementation (Amelia V-Spot) improves pregnancy outcomes in women undergoing frozen embryo transfer (FET) treatment as part of in-vitro fertilisation (IVF). Women under 45 years of age with a genetically tested normal (euploid) embryo undergoing FET will be randomly assigned to receive either a vaginal probiotic or placebo treatment. The main objective is to determine whether vaginal probiotics improve clinical pregnancy rates with FET. Secondary outcomes include ongoing pregnancy rates, miscarriage rates, live birth outcomes, changes in the vaginal microbiome, and any treatment-related side effects. The study will be conducted at an IVF centre in Sydney, Australia, with industry funding from Amelia Bio.

Interventions

Intervention: Vaginal probiotic supplementation (Amelia V-Spot - containing 4 strains of lactobacillus) Dose: once vaginal suppository daily (Lactobacillus crispatus 2 billion CFU, Lactobacillus rhamnosus GR-1 1.25 billion CFU, Lactobacillus reuteri RC-14 1.25 billion CFU, Lactobacillus gasseri 2 billion CFU) Duration of treatment: approximately 2 weeks (from cessation of menses to embryo transfer) Mode of delivery: vaginal pessary Adherence: participant self-reporting and review at treatment

Study design

Allocation

Randomised controlled trial

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

No minimum to 45 Years

Healthy volunteers

Inclusion criteria

• Women with infertility • Age < 45 years age • Attending for a FET cycle with a single euploid embryo • Willing to provide informed consent, willing to participate and comply with study requirements

Exclusion criteria

• Recurrent implantation failure (= 3 consecutive implantation failures) • Known uterine anomaly or genetic condition • Symptomatic with vaginal infection • Oral or vaginal probiotic use • Oral antibiotic use at commencement of cycle • Allergy or hypersensitivity to suppository ingredients (lactose, maltodextrin, sodium ascorbate, sucrose, microcrystalline cellulose, magnesium stearate, colloidal silicone anhydrous, maltose) • Circumstances/conditions which may interfere with the participant’s ability to give informed consent

Outcome results