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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-40
SponsorKarolinska Institutet

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

Women who do not have a child yet and plan to cease their contraception.

Trial population

Women with previously proven fertility who plan to become pregnant. The women will be recruited at the time of removal of a copper or hormonal intrauterine device (IUD) or removal of a contraceptive implant

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

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

Time frame
2024

Secondary outcomes

1

Microbiome profiles and metabolome related to obstetric outcomes

Time frame
2024
2

The microbiome profile for women above age >38 and women below <38.

Time frame
2024
3

The influence of BMI, medications and comorbidities on the microbiome profiles.

Time frame
2024
4

Microbiome profile for those women who don't conceive within a year.

Time frame
2024

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Karolinska Institutet

Lead sponsor

Karolinska University Hospital

Collaborator