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

Contraception Clinical Trial

— SweBioFertil  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05127252
• Other study ID #: Dnr 2021-03765
• Status: Recruiting
• 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
• 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.

Related Conditions & MeSH terms

• Communicable Diseases
• Contraception
• Fertility
• Infections
• Metabolome
• Microbial Colonization
• Pregnancy Complications
• Pregnancy Loss

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