Contraception Clinical Trial
— SweBioFertilOfficial title:
Impact of the Microbiome on Time to Pregnancy and Pregnancy Outcomes in Fertile Women Attempting to Conceive
This study aims to investigate the microbiome of women with previously proven fertility who plan to become pregnant.
Status | Recruiting |
Enrollment | 500 |
Est. completion date | December 30, 2026 |
Est. primary completion date | March 10, 2026 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 40 Years |
Eligibility | Inclusion Criteria: - 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. Exclusion Criteria: - Women who do not have a child yet and plan to cease their contraception. |
Country | Name | City | State |
---|---|---|---|
Sweden | Reproductive Medicine, Karolinska University Hospital | Stockholm | Huddinge |
Sweden | Reproduktionscentrum Akademiska sjukhuset | Uppsala |
Lead Sponsor | Collaborator |
---|---|
Karolinska Institutet | Karolinska University Hospital |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The microbiome profile and metabolome associated with time to pregnancy, miscarriage, and live birth will be assessed. | 2024 | ||
Secondary | Microbiome profiles and metabolome related to obstetric outcomes | 2024 | ||
Secondary | The microbiome profile for women above age >38 and women below <38. | 2024 | ||
Secondary | The influence of BMI, medications and comorbidities on the microbiome profiles. | 2024 | ||
Secondary | Microbiome profile for those women who don't conceive within a year. | 2024 | ||
Secondary | The metabolome of the recognized microbiome for women with normal pregnancy outcomes | 2024 | ||
Secondary | The metabolome of the recognized microbiome for women who develop miscarriage or other pregnancy complications | 2024 |
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