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

May 26, 2023 updated by: Kenny Rodriguez-Wallberg, Karolinska Institutet
This study aims to investigate the microbiome of women with previously proven fertility who plan to become pregnant.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Sweden
      • Uppsala, Sweden, 751 85
        • Recruiting
        • Reproduktionscentrum Akademiska sjukhuset
        • Contact:
          • Farnaz Bazargani, MD
    • Huddinge
      • Stockholm, Huddinge, Sweden, 141 57
        • Not yet recruiting
        • Reproductive Medicine, Karolinska University Hospital
        • Principal Investigator:
          • Kenny Rodriguez-Wallberg, Proff

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study 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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The microbiome profile and metabolome associated with time to pregnancy, miscarriage, and live birth will be assessed.
Time Frame: 2024
2024

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska Institutet

Collaborators

Karolinska University Hospital

Investigators

  • Study Chair: Lars Holmgren, Professor, Karolinska Institutet

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 10, 2023

Primary Completion (Estimated)

March 10, 2026

Study Completion (Estimated)

December 30, 2026

Study Registration Dates

First Submitted

November 9, 2021

First Submitted That Met QC Criteria

November 18, 2021

First Posted (Actual)

November 19, 2021

Study Record Updates

Last Update Posted (Actual)

May 30, 2023

Last Update Submitted That Met QC Criteria

May 26, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Dnr 2021-03765

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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