RecruitingNCT05127252

Impact of the Microbiome on Time to Pregnancy and Pregnancy Outcomes in Fertile Women Attempting to Conceive

Sponsor

Karolinska Institutet

Enrollment

500 participants

Start Date

Apr 10, 2023

Study Type

OBSERVATIONAL

Conditions

Fertility Contraception Pregnancy Complications Pregnancy Loss Microbial Colonization Metabolome

Summary

This study aims to investigate the microbiome of women with previously proven fertility who plan to become pregnant.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 40 Years

Inclusion Criteria4

Women with a previous live birth in the past 5 years and planning a new pregnancy with the same male partner.
-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 Criteria1

Women who do not have a child yet and plan to cease their contraception.

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Interventions

DIAGNOSTIC_TESTVaginal and rectal microbiome and metabolome

Vaginal- 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.