NCT05127252

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 500 (estimated)
• Sponsor: Karolinska Institutet · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

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

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

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	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.

Timeline

• Start date: 2023-04-10
• Primary completion: 2026-03-10
• Completion: 2026-12-30
• First posted: 2021-11-19
• Last updated: 2023-05-30

Locations

2 sites across 1 country: Sweden