NCT05150639

Vaginal Microbiome and IVF Pregnancy Outcome

Associations Between the Vaginal Microbiome, Inflammatory Status and Pregnancy Outcome - a Prospective, Observational Study in Women Undergoing Frozen Embryo Transfers.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 301 (actual)
• Sponsor: Freya Biosciences ApS · Industry
• Sex: Female
• Age: 18 Years – 44 Years
• Healthy volunteers: Accepted

Summary

The aim of this prospective, observational study is to investigate the prevalence of vaginal dysbiosis among women undergoing IVF procedures in the US. And to investigate the associations between the vaginal microbiome and the pregnancy outcome following IVF.

Detailed description

The present study will evaluate differences in vaginal microbiome composition in pregnant and non pregnant women who have undergone IVF treatment with frozen embryo transfer. Concurrently we aim to identify whether menstrual tissue and Cervicovaginal secretion possess complimentary biomarker information reflecting the immune/inflammatory status of the reproductive tract to determine its impact on pregnancy success following frozen embryo transfer IVF procedure.

Conditions

• Vaginal Flora Imbalance

Interventions

Type	Name	Description
OTHER	IVF	Women planning to undergo frozen embryo transfer IVF procedure will be included. Samples will be obtained, but no study intervention will be applied. Pregnancy outcome data will be obtained, following frozen embryo transfer, to correlate against other data from samples (vaginal microbiome etc).

Timeline

• Start date: 2022-03-18
• Primary completion: 2023-05-26
• Completion: 2023-05-26
• First posted: 2021-12-09
• Last updated: 2026-03-02

Locations

1 site across 1 country: United States