Pregnancy ComplicationsSweBioFertilNCT05127252
Impact of the Microbiome on Time to Pregnancy and Pregnancy Outcomes in Fertile Women Attempting to Conceive
An observational study of Pregnancy Complications and Contraception, run by Karolinska Institutet at 2 sites in Sweden.
Trial summary
This study aims to investigate the microbiome of women with previously proven fertility who plan to become pregnant. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Complications, Contraception, Pregnancy Loss
- What is being tested?
- Vaginal and rectal microbiome and metabolome
- How many people
- 500 participants
- Where
- 2 sitesSweden
- Study dates
- 10 Apr 2023to 30 Dec 2026
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
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
Who may be able to join
- 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.
Who cannot join
- Women who do not have a child yet and plan to cease their contraception.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Sebastian Sebastian Brusell Gidlöf, PhD contact
Sweden2 sites, 2 recruiting
- Not yet recruiting
Reproductive Medicine, Karolinska University Hospital
Stockholm, Huddinge, 141 57
Kenny Rodriguez-Wallberg, Proff
- Recruiting
Reproduktionscentrum Akademiska sjukhuset
Uppsala, 751 85
Farnaz Bazargani, MD
About this study
This study aims to investigate the microbiome of women with previously proven fertility who plan to become pregnant.
Read the 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.
- Conditions
- Pregnancy Complications, Contraception, Pregnancy Loss, Fertility, Microbial Colonization, Metabolome
- Being tested
- Vaginal and rectal microbiome and metabolome
- Keywords
- cohort, fertility, microbiome, microbiota
- Medical subject headings
- Pregnancy Complications, Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaginal and rectal microbiome and metabolomeDiagnostic test
Also called SweBioFertil
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 being measured
The primary outcome is the main question the study is designed to answer.
The microbiome profile and metabolome associated with time to pregnancy, miscarriage, and live birth will be assessed.
Measured: 2024
Secondary outcomes (6)
Microbiome profiles and metabolome related to obstetric outcomes
Measured: 2024
The microbiome profile for women above age >38 and women below <38.
Measured: 2024
The influence of BMI, medications and comorbidities on the microbiome profiles.
Measured: 2024
Microbiome profile for those women who don't conceive within a year.
Measured: 2024
The metabolome of the recognized microbiome for women with normal pregnancy outcomes
Measured: 2024
The metabolome of the recognized microbiome for women who develop miscarriage or other pregnancy complications
Measured: 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2021
- Study start10 Apr 2023
- Primary completion10 Mar 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy ComplicationsStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska University Hospital
- Responsible party
- Principal investigator, Kenny Rodriguez-Wallberg, Karolinska Institutet
- Investigators
- Lars Holmgren, Professor, Study chair, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05127252
- Sponsor's protocol ID
- Dnr 2021-03765
- Acronym
- SweBioFertil
- Status last verified
- May 2023
- First submitted
- 9 Nov 2021
- Last updated
- 30 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Microbiome on Time to Pregnancy and Pregnancy Outcomes in Fertile Women Attempting to Conceive
- ClinicalTrials.gov ID
- NCT05127252
- Acronym / sponsor ID
- SweBioFertil / Dnr 2021-03765
- Conditions
- Pregnancy Complications, Contraception, Pregnancy Loss, Fertility, Microbial Colonization, Metabolome
- Keywords
- cohort, fertility, microbiome, microbiota
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Karolinska University Hospital
- Study start
- 10 Apr 2023 (actual)
- Primary completion
- 10 Mar 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 19 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Women who do not have a child yet and plan to cease their contraception.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vaginal and rectal microbiome and metabolomeAlso: SweBioFertilVaginal- 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. | Diagnostic test | – |
Primary outcome
The microbiome profile and metabolome associated with time to pregnancy, miscarriage, and live birth will be assessed.
Time frame: 2024
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sebastian Sebastian Brusell Gidlöf, PhD contact
Lars Holmgren, Professor study chair
Karolinska Institutet
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy Complications and Contraception, run by Karolinska Institutet at 2 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lars Holmgren, Professor (046734036794, lars.holmgren@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The microbiome profile and metabolome associated with time to pregnancy, miscarriage, and live birth will be assessed. (time frame: 2024). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2023.