Clinical trial NCT05127252: Impact of the Microbiome on Time to Pregnancy and Pregnancy Outcomes in Fertile Women Attempting to Conceive
Official title: Impact of the Microbiome on Time to Pregnancy and Pregnancy Outcomes in Fertile Women Attempting to Conceive
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pregnancy Complications
Contraception
Pregnancy Loss
Fertility
Microbial Colonization
Metabolome
Keywords: cohort
fertility
microbiome
microbiota
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Karolinska University Hospital
First posted: 2021-11-19
Enrollment: 500
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The microbiome profile and metabolome associated with time to pregnancy, miscarriage, and live birth will be assessed.
timeFrame: 2024
Secondary outcomes:
measure: Microbiome profiles and metabolome related to obstetric outcomes
timeFrame: 2024
measure: The microbiome profile for women above age >38 and women below <38.
timeFrame: 2024
measure: The influence of BMI, medications and comorbidities on the microbiome profiles.
timeFrame: 2024
measure: Microbiome profile for those women who don't conceive within a year.
timeFrame: 2024
measure: The metabolome of the recognized microbiome for women with normal pregnancy outcomes
timeFrame: 2024
measure: The metabolome of the recognized microbiome for women who develop miscarriage or other pregnancy complications
timeFrame: 2024
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Reproductive Medicine, Karolinska University Hospital
state: Huddinge
city: Uppsala
country: Sweden
facility: Reproduktionscentrum Akademiska sjukhuset
Study officials:
affiliation: Karolinska Institutet
name: Lars Holmgren, Professor
role: STUDY_CHAIR
References: