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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05127252
Other study ID # Dnr 2021-03765
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 10, 2023
Est. completion date December 30, 2026

Study information

Verified date May 2023
Source Karolinska Institutet
Contact Lars Holmgren, Professor
Phone 046734036794
Email lars.holmgren@ki.se
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 500
Est. completion date December 30, 2026
Est. primary completion date March 10, 2026
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 40 Years
Eligibility 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 Design


Intervention

Diagnostic Test:
Vaginal and rectal microbiome and metabolome
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.

Locations

Country Name City State
Sweden Reproductive Medicine, Karolinska University Hospital Stockholm Huddinge
Sweden Reproduktionscentrum Akademiska sjukhuset Uppsala

Sponsors (2)

Lead Sponsor Collaborator
Karolinska Institutet Karolinska University Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary The microbiome profile and metabolome associated with time to pregnancy, miscarriage, and live birth will be assessed. 2024
Secondary Microbiome profiles and metabolome related to obstetric outcomes 2024
Secondary The microbiome profile for women above age >38 and women below <38. 2024
Secondary The influence of BMI, medications and comorbidities on the microbiome profiles. 2024
Secondary Microbiome profile for those women who don't conceive within a year. 2024
Secondary The metabolome of the recognized microbiome for women with normal pregnancy outcomes 2024
Secondary The metabolome of the recognized microbiome for women who develop miscarriage or other pregnancy complications 2024
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