Microbiome and metabolome profiles in couples having IVF
Official title: Microbiome and Metabolome Profiles in Couples Undergoing IVF and Their Association With Reproductive Outcomes in a Prospective Longitudinal Cohort Study
Run by Karolinska Institutet · NCT07532629 · Data updated 2026-11-12
This will test whether partners' microbiome and metabolome profiles are linked to fertilization, pregnancy, and live birth in couples having IVF.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 40 Years |
| Sex | All |
| Enrollment | 1000 (estimated) |
| Sponsor | Karolinska Institutet Academic / other |
| Locations | 3 sites (Malmö and 2 other locations) |
| Status | Recruiting |
| Started | June 10, 2022 |
| Main results expected | August 20, 2028 |
| Study ends | March 1, 2029 |
| Registry record updated | April 16, 2026 |
| Trial ID | NCT07532629 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Heterosexual couples planning IVF at participating Swedish centers where women are aged 18–40, men 18–56, and who can understand Swedish or English are ideal candidates.
✕Probably not a fit
People who are already pregnant, have used systemic antibiotics within the past four weeks, or have an active genital infection may be excluded or less likely to benefit, and because the study is observational participants should not expect direct treatment benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective observational cohort enrolling heterosexual couples undergoing IVF at Swedish fertility clinics. Semen from male partners and vaginal and blood samples from female partners will be collected and analyzed using DNA sequencing for microbiome composition and metabolomic profiling. Samples and clinical data will be linked longitudinally to national health registers to capture outcomes including fertilization rates, embryo development, clinical pregnancy, miscarriage, preterm birth, preeclampsia, and live birth. Analyses will examine associations between microbial diversity, specific taxa, metabolic signatures, and reproductive and obstetric outcomes in both partners.
Why it matters
Potential benefit: If successful, the findings could identify microbial or metabolic markers that help predict IVF success and guide strategies to improve chances of pregnancy and healthy live birth.
How similar studies have gone: Previous studies have linked the female reproductive tract microbiome to IVF and pregnancy outcomes, but combining both partners' microbiomes with metabolomic profiling is still relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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Reproduktionsmottagning Malmö, Skånes universitetssjukhus
Malmö, Sweden Recruiting -
Karolinska Universitetssjukhuset
Stockholm, Sweden Recruiting -
Reproduktionscenter, Akademiska sjukuhset
Uppsala, Sweden Recruiting
Study contacts
- Principal investigator: Kenny A. Rodriguez-Wallberg, MD., PhD — Oncology-pathology, Karolinska Institutet
- Study coordinator: Ola Larsson, PhD
- Email: ola.larsson@ki.se
- Phone: +46 8 524 80000
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.