NCT05127252

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
8mo left

Started Apr 2023

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress83%
Apr 2023Dec 2026

First Submitted

Initial submission to the registry

November 9, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 19, 2021

Completed
1.4 years until next milestone

Study Start

First participant enrolled

April 10, 2023

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 10, 2026

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2026

Expected
Last Updated

May 30, 2023

Status Verified

May 1, 2023

Enrollment Period

2.9 years

First QC Date

November 9, 2021

Last Update Submit

May 26, 2023

Conditions

Pregnancy ComplicationsContraceptionPregnancy LossFertilityMicrobial ColonizationMetabolome

Keywords

cohortfertilitymicrobiomemicrobiota

Outcome Measures

Primary Outcomes (1)

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

    2024

Secondary Outcomes (6)

  • 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

  • +1 more secondary outcomes

Interventions

Vaginal and rectal microbiome and metabolomeDIAGNOSTIC_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.

Also known as: SweBioFertil

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-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

You may qualify if:

  • Women with a previous live birth in the past 5 years and planning a new pregnancy with the same male partner.
  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Reproductive Medicine, Karolinska University Hospital

Stockholm, Huddinge, 141 57, Sweden

NOT YET RECRUITING

Reproduktionscentrum Akademiska sjukhuset

Uppsala, 751 85, Sweden

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

The samples will be analyzed on the high-throughput pipeline for microbiome studies at CTMR at KI. The pipeline includes standardized DNA extraction steps, library prep and shotgun metagenomic sequencing on the MGI sequencers available at the centre. Dedicated bioinformatic pipelines for taxonomy and functional capacity of the microbiome will be applied.

MeSH Terms

Conditions

Pregnancy ComplicationsCommunicable Diseases

Interventions

Metabolome

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesInfectionsDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Metabolism

Study Officials

  • Lars Holmgren, Professor

    Karolinska Institutet

    STUDY CHAIR

Central Study Contacts

Lars Holmgren, Professor

CONTACT

046734036794lars.holmgren@ki.se

Sebastian Sebastian Brusell Gidlöf, PhD

CONTACT

08-517 700 00sebastian.brusell-gidlof@regionstockholm.se

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD, Professor

Study Record Dates

First Submitted

November 9, 2021

First Posted

November 19, 2021

Study Start

April 10, 2023

Primary Completion

March 10, 2026

Study Completion (Estimated)

December 30, 2026

Last Updated

May 30, 2023

Record last verified: 2023-05

Locations

SE(2)