About this trial
This study aims to investigate the microbiome of women with previously proven fertility who plan to become pregnant.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Women with a previous live birth in the past 5 years and planning a new pregnancy with the same male partner.
18-40 years of age
Swedish personal identity number and a Swedish address (to send a sampling self-kit)
Sufficient understanding of spoken and written Swedish or English to provide informed consent and complete the web-based questionnaire.
Disqualifiers
Women who do not have a child yet and plan to cease their contraception.
Trial population
Women with previously proven fertility who plan to become pregnant. The women will be recruited at the time of removal of a copper or hormonal intrauterine device (IUD) or removal of a contraceptive implant
Trial design
Cohort
Prospective
Treatments tested in this trial
Vaginal and rectal microbiome and metabolome
Diagnostic testVaginal- and rectal sampling as a self-kit will be taken by the pat when ceasing the contraception at the midwife clinic when confirmed a clinical pregnancy and if a miscarriage occurs. If a miscarriage occurs additionally to the self-kit an endometrial biopsy will be taken.
Treatment groups
Trial outcomes
Primary outcomes
The microbiome profile and metabolome associated with time to pregnancy, miscarriage, and live birth will be assessed.
Secondary outcomes
Microbiome profiles and metabolome related to obstetric outcomes
The microbiome profile for women above age >38 and women below <38.
The influence of BMI, medications and comorbidities on the microbiome profiles.
Microbiome profile for those women who don't conceive within a year.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Karolinska Institutet
Lead sponsor
Karolinska University Hospital
Collaborator