NCT07532629 Microbiome and Metabolome Profiles in Couples Undergoing IVF and Reproductive Outcomes
| NCT ID | NCT07532629 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Karolinska Institutet |
| Condition | Infertility |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2022-06-10 |
| Primary Completion | 2028-08-20 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,000 participants in total. It began in 2022-06-10 with a primary completion date of 2028-08-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Kenny A. Rodriguez-Wallberg, MD., PhD
PRINCIPAL INVESTIGATOR
Oncology-pathology, Karolinska Institutet
Frequently Asked Questions
Who can join the NCT07532629 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 40 Years, studying Infertility. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07532629 currently recruiting?
Yes, NCT07532629 is actively recruiting participants. Contact the research team at ola.larsson@ki.se for enrollment information.
Where is the NCT07532629 trial being conducted?
This trial is being conducted at Malmö, Sweden, Stockholm, Sweden, Uppsala, Sweden.
Who is sponsoring the NCT07532629 clinical trial?
NCT07532629 is sponsored by Karolinska Institutet. The principal investigator is Kenny A. Rodriguez-Wallberg, MD., PhD at Oncology-pathology, Karolinska Institutet. The trial plans to enroll 1,000 participants.