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

Sponsor

Karolinska Institutet (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05127252

Collaborator

Karolinska University Hospital (Other)

500

Enrollment

Location

35.6

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Pregnancy Complications Contraception Pregnancy Loss Fertility Microbial Colonization Metabolome	Diagnostic Test: Vaginal and rectal microbiome and metabolome

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 Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

500 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Jan 10, 2022

Anticipated Primary Completion Date :

Dec 30, 2024

Anticipated Study Completion Date :

Dec 30, 2024

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Microbiome profiles and metabolome related to obstetric outcomes [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]
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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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.