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Microbiome and Metabolome Profiles in Couples Undergoing IVF and Reproductive Outcomes

Recruitingn/aAges 18 Years - 40 YearsAllKarolinska Institutet
NCT07532629 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Not listed
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Where

3 sites
Reproduktionsmottagning Malmö, Skånes universitetssjukhus
Malmö, Sweden
Karolinska Universitetssjukhuset
Stockholm, Sweden
Reproduktionscenter, Akademiska sjukuhset
Uppsala, Sweden
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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