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

Karolinska Institute

Status: Enrolling

Conditions: Metabolome; Pregnancy Complications; Fertility; Contraception; Pregnancy Loss; Microbial Colonization

Treatments: Diagnostic Test: Vaginal and rectal microbiome and metabolome

Study type: Observational

Funder types: Other

Identifiers

NCT05127252

Dnr 2021-03765

Details and patient eligibility

About

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

Full 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.

Enrollment: 500 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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.