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Clinical Trials in Sweden / NCT07532629
Recruiting Observational

Microbiome and Metabolome Profiles in Couples Undergoing IVF and Reproductive Outcomes

NCT07532629 · tracked via the Priya Life Science Sweden tracker
Sponsor
Karolinska Institutet
Phase
Observational
Started
2022-06-10
Last updated
2026-04-16

Condition(s) studied

InfertilityAssisted Reproductive TechnologyPregnancy ComplicationsPregnancy Loss, EarlyMetabolomeMicrobiome

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
40 Years
Healthy volunteers
Accepted
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

Primary outcome measure(s)

Trial sites (3)

FacilityCityRegionStatus
Reproduktionsmottagning Malmö, Skånes universitetssjukhus Malmö Sweden Recruiting
Karolinska Universitetssjukhuset Stockholm Sweden Recruiting
Reproduktionscenter, Akademiska sjukuhset Uppsala Sweden Recruiting

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Other trials for the same condition

Efficacy and Safety of Fertility Treatments and Fertility Preservation Recruiting
Development of an International Remote Digital Care System for Accessible, Inclusive and Sustainable Pregnancy Care Enrolling by invitation
COPE - COVID-19 in Pregnancy and Early Childhood Active, not recruiting
Physical and Mental Health Among Sexual and Gender Minorities During Pregnancy, Birth and Postpartum Active, not recruiting
Impact of the Microbiome on Time to Pregnancy and Pregnancy Outcomes in Fertile Women Attempting to Conceive Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07532629 on ClinicalTrials.gov ↗ ← All trials in Sweden