Microbiome and Metabolome Profiles in Couples Undergoing IVF and Reproductive Outcomes
Recruiting now
Conditions studied: Infertility, Assisted Reproductive Technology, Pregnancy Complications, Pregnancy Loss, Early, Metabolome, Microbiome
In brief
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.
Key facts
- Study ID
- NCT07532629
- Run by
- Karolinska Institutet
- People needed
- 1000
- Starts
- 2022-06-10
- Expected to finish
- 2029-03-01
- Last updated by the study team
- 2026-04-16
Who can join
Age: 18 and older, up to 40. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Reproduktionsmottagning Malmö, Skånes universitetssjukhus — Malmö, Sweden (enrolling)
- Karolinska Universitetssjukhuset — Stockholm, Sweden (enrolling)
- Reproduktionscenter, Akademiska sjukuhset — Uppsala, Sweden (enrolling)
Full record on ClinicalTrials.gov
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