RecruitingNot Applicable

Microbiome and Metabolome Profiles in Couples Undergoing IVF and Reproductive Outcomes

Sweden1,000 participantsStarted 2022-06-10

Plain-language 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.

Who can participate

Age range18 Years – 40 Years

SexALL

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Inclusion Criteria: * 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. Exclusion Criteria: * 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

What they're measuring

Number of Participants with Live Birth

Timeframe: Through delivery, up to 12 months after embryo transfer

Trial details

NCT IDNCT07532629

SponsorKarolinska Institutet

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2028-08-20

Contact for this trial

Ola Larsson, PhD

+46 8 524 80000 ola.larsson@ki.se

View on ClinicalTrials.gov More Infertility trials