Clinical Trial

Microbiome and Metabolome Profiles in Couples Undergoing IVF and Reproductive Outcomes

Study acronym: Mi IVF
Recruiting
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Summary
This prospective observational cohort study investigates the role of the microbiome and metabolome in couples undergoing in vitro fertilization. Biological samples will be collected from both female and male partners, including semen, vaginal, and blood samples, to characterize microbial composition and metabolic profiles. The study aims to examine how these biological profiles are associated with reproductive outcomes such as fertilization, pregnancy, miscarriage, and live birth. Participants will be followed longitudinally, and reproductive and obstetric outcomes will be obtained through linkage with national health registers.
Trial Details
NCT Number NCT07532629
Lead Sponsor Karolinska Institutet
Conditions Infertility, Assisted Reproductive Technology, Pregnancy Complications, Pregnancy Loss, Early, Metabolome, Microbiome
Enrollment 1,000 participants
Start Date 2022-06-10
Primary Completion 2028-08-20 (estimated)
Study Completion 2029-03-01 (estimated)
Updated on ClinicalTrials.gov 2026-04-16