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

Sponsor
Karolinska Institutet
Study ID
NCT05127252
Status
Recruiting
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Conditions

  • Contraception
  • Fertility
  • Metabolome
  • Microbial Colonization
  • Pregnancy Complications
  • Pregnancy Loss

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 40 Years
Healthy Volunteers
Accepted

Interventions

  • Vaginal and rectal microbiome and metabolome — DIAGNOSTIC_TEST
    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.

Study Details

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

Key Dates

First listed
Nov 19, 2021
Start date
Apr 10, 2023
Status verified
May 2023
Primary completion
Mar 10, 2026
Completion
Dec 30, 2026

Study Design

Enrollment
500 participants (estimated)

Primary Outcome Measure

The microbiome profile and metabolome associated with time to pregnancy, miscarriage, and live birth will be assessed. [ Time Frame: 2024 ]

Central Contacts

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