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| Name | Class |
|---|---|
| Karolinska University Hospital | OTHER |
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This study aims to investigate the microbiome of 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 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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vaginal and rectal microbiome and metabolome | Diagnostic Test | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The microbiome profile and metabolome associated with time to pregnancy, miscarriage, and live birth will be assessed. | 2024 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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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
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lars Holmgren, Professor | Contact | 046734036794 | lars.holmgren@ki.se | |
| Sebastian Sebastian Brusell Gidlöf, PhD | Contact | 08-517 700 00 | sebastian.brusell-gidlof@regionstockholm.se |
| Name | Affiliation | Role |
|---|---|---|
| Lars Holmgren, Professor | Karolinska Institutet | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Reproductive Medicine, Karolinska University Hospital | Not yet recruiting | Stockholm | Huddinge | 141 57 | Sweden |
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The samples will be analyzed on the high-throughput pipeline for microbiome studies at CTMR at KI. The pipeline includes standardized DNA extraction steps, library prep and shotgun metagenomic sequencing on the MGI sequencers available at the centre. Dedicated bioinformatic pipelines for taxonomy and functional capacity of the microbiome will be applied.
| 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 |
| Reproduktionscentrum Akademiska sjukhuset | Recruiting | Uppsala | 751 85 | Sweden |
|
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D003141 | Communicable Diseases |
| ID | Term |
|---|---|
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007239 | Infections |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D055442 | Metabolome |
| ID | Term |
|---|---|
| D008660 | Metabolism |
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