Impact of the Microbiome on Time to Pregnancy and Pregnancy Outcomes in Fertile Women Attempting to Conceive
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Vaginal and rectal microbiome and metabolome.
- Who it may be relevant to
- Registry conditions: Pregnancy Complications, Contraception, Pregnancy Loss, Fertility. Basic parameters: 18 years — 40 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Sweden
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- 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.
Primary outcome measures
- The microbiome profile and metabolome associated with time to pregnancy, miscarriage, and live birth will be assessed. [Time frame: 2024]
Secondary outcome measures (6)
- Microbiome profiles and metabolome related to obstetric outcomes [Time frame: 2024]
- The microbiome profile for women above age >38 and women below <38. [Time frame: 2024]
- The influence of BMI, medications and comorbidities on the microbiome profiles. [Time frame: 2024]
- Microbiome profile for those women who don't conceive within a year. [Time frame: 2024]
- The metabolome of the recognized microbiome for women with normal pregnancy outcomes [Time frame: 2024]
- The metabolome of the recognized microbiome for women who develop miscarriage or other pregnancy complications [Time frame: 2024]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Sweden · 2 centers
- Reproductive Medicine, Karolinska University Hospital — Stockholm
- Reproduktionscentrum Akademiska sjukhuset — Uppsala
Identifiers
NCT: NCT05127252 · Dnr 2021-03765