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.
Women aged 18 to 40 years at enrolment.
Men aged between 18 to 56 years at enrolment.
Couples planning to undergo IVF treatment at a participating centre.
Sufficient understanding of spoken and written Swedish or English to provide informed consent and complete the web-based questionnaire.
Pregnancy at the time of enrolment (confirmed or suspected).
Recent systemic antibiotic use within the past 4 weeks
Active vaginal or genital tract infection at the time of sampling
Couples undergoing in vitro fertilization (IVF) treatment at participating fertility clinics in Sweden. Eligible couples are consecutively recruited at the time of IVF treatment initiation and followed prospectively for reproductive outcomes through linkage with national health registers.
Cohort
Prospective
Not listed
Number of Participants with Live Birth
Delivery of a live-born infant after IVF treatment, identified through linkage with national health registers.
Number of Participants With Miscarriage Before 22 Weeks of Gestation
Pregnancy loss before 22 weeks of gestation identified through linkage with national pregnancy registers.
Number of Participants With Preterm Birth Before 37 Completed Weeks of Gestation
Delivery before 37 completed weeks of gestation identified through national birth registers.
Number of Participants With Preeclampsia
Diagnosis of preeclampsia recorded in national health registers according to ICD codes.
Relative Abundance of Prespecified Microbial Taxa in Female Reproductive Tract Samples
Relative abundance of prespecified microbial taxa measured in female reproductive tract samples collected at baseline using sequencing-based metagenomic profiling.
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