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

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

Detailed Description
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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.

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

Conditions
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Pregnancy Complications, Contraception, Pregnancy Loss, Fertility, Microbial Colonization, Metabolome

Intervention / Treatment
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* Diagnostic Test: Vaginal and rectal microbiome and metabolome


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The microbiome profile and metabolome associated with time to pregnancy, miscarriage, and live birth will be assessed. |  | 2024 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Microbiome profiles and metabolome related to obstetric outcomes |  | 2024 | 
| The microbiome profile for women above age >38 and women below <38. |  | 2024 | 
| The influence of BMI, medications and comorbidities on the microbiome profiles. |  | 2024 | 
| Microbiome profile for those women who don't conceive within a year. |  | 2024 | 
| The metabolome of the recognized microbiome for women with normal pregnancy outcomes |  | 2024 | 
| The metabolome of the recognized microbiome for women who develop miscarriage or other pregnancy complications |  | 2024 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cohort, fertility, microbiome, microbiota