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NCT Number: NCT05127252

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

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

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Key information

Conditions

Pregnancy Complications Communicable Diseases Contraception Disease Attributes Female Urogenital Diseases and Pregnancy Complications Fertility Infections Metabolome Microbial Colonization Pathologic Processes Pathological Conditions, Signs and Symptoms Pregnancy Loss Urogenital Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

Reproductive Medicine, Karolinska University Hospital, Stockholm, Huddinge, Sweden

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: SweBioFertil

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

  5. The metabolome of the recognized microbiome for women with normal pregnancy outcomes

    Time frame: 2024

  6. The metabolome of the recognized microbiome for women who develop miscarriage or other pregnancy complications

    Time frame: 2024

Study contacts

Contact information is provided by the study sponsor or research team.

Lars Holmgren, Professor

CONTACT

[email protected]

046734036794

Sebastian Sebastian Brusell Gidlöf, PhD

CONTACT

[email protected]

08-517 700 00

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

  • Karolinska University Hospital

Registry information

Acronym: SweBioFertil

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Nov 19, 2021
Registry last updated
May 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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