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

Recruiting

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

• Registration Number: NCT05127252
• Lead Sponsor: Karolinska Institutet

Brief 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.

Study Timeline

• Study First Submitted: 2021-11-09
• Study First Submitted QC: 2021-11-18
• Study First Posted: 2021-11-19
• Study Start: 2023-04-10
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-26
• Last Update Posted: 2023-05-30
• Primary Completion: 2026-03-10
• Study Completion: 2026-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 500

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The microbiome profile and metabolome associated with time to pregnancy, miscarriage, and live birth will be assessed.	2024

Secondary Outcome Measures

Name	Time	Method
Microbiome profiles and metabolome related to obstetric outcomes	2024
Microbiome profile for those women who don't conceive within a year.	2024
The metabolome of the recognized microbiome for women with normal pregnancy outcomes	2024
The metabolome of the recognized microbiome for women who develop miscarriage or other pregnancy complications	2024
The microbiome profile for women above age >38 and women below <38.	2024
The influence of BMI, medications and comorbidities on the microbiome profiles.	2024

Trial Locations

Locations (2)

Reproductive Medicine, Karolinska University Hospital; 🇸🇪 Stockholm, Huddinge, Sweden

Reproduktionscentrum Akademiska sjukhuset; 🇸🇪 Uppsala, Sweden