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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-04-10

Study Completion Date

2026-12-30

Brief Summary

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

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Detailed Description

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The women will be recruited at the time of removal of a copper or hormonal intrauterine device (IUD) or removal of a contraceptive implant at the barnmorskemottagningar (midwife clinics) in Stockholm's county in Sweden. A total of 500 women will be included in the study and will be followed until conception or up to the end of 1 year, whichever comes first. If conception occurs, the woman will be followed throughout pregnancy. Participant recruitment will take place over a period of two years.

Conditions

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Pregnancy Complications Contraception Pregnancy Loss Fertility Microbial Colonization Metabolome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Vaginal 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.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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SweBioFertil

Eligibility Criteria

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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.