Actively Recruiting
Impact of the Microbiome on Time to Pregnancy and Pregnancy Outcomes in Fertile Women Attempting to Conceive
Led by Karolinska Institutet · Updated on 2023-05-30
500
Participants Needed
2
Research Sites
42 weeks
Total Duration
On this page
Sponsors
K
Karolinska Institutet
Lead Sponsor
K
Karolinska University Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying the microbiome and metabolome in women who have previously given birth and are planning to conceive again with the same partner. This observational study aims to understand how these biological factors relate to time to pregnancy, miscarriage, live birth, and pregnancy complications. The study will follow 500 women, recruited when they stop using contraception, over up to one year or until conception, and then through pregnancy if conception occurs. Participants will provide vaginal and rectal samples using a self-collection kit at the time they stop their contraceptive method, such as a copper or hormonal IUD or contraceptive implant, at midwife clinics in Stockholm. If a miscarriage occurs, an additional endometrial biopsy will be collected. Recruitment is planned over two years, with participants followed throughout conception and pregnancy. During the study, women will complete web-based questionnaires and provide biological samples. Researchers will assess microbiome profiles and metabolome related to pregnancy outcomes, including time to pregnancy, miscarriage, and live birth. They will also examine influences of age, BMI, medications, and other health factors on the microbiome. The study will monitor participants for up to one year or through pregnancy, with data collected to better understand fertility and pregnancy outcomes.
CONDITIONS
Brief Title
Impact of the Microbiome on Time to Pregnancy and Pregnancy Outcomes in Fertile Women Attempting to Conceive
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women with a previous live birth in the past 5 years and planning a new pregnancy with the same male partner
- Age 18 to 40 years
- Swedish personal identity number and address
- Sufficient understanding of spoken and written Swedish or English to provide informed consent and complete the web-based questionnaire
You will not qualify if you...
- Women who do not have a child yet and plan to cease their contraception
AI-Screening
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Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 1 year or until conception, whichever comes first
Participants who have ceased contraception are observed and vaginal and rectal microbiome samples are collected using a self-kit at the time of contraception removal, at confirmed clinical pregnancy, and if a miscarriage occurs. An endometrial biopsy is also taken if a miscarriage occurs.
1 visit at contraception removal, additional visits at confirmed pregnancy and if miscarriage occurs
Duration - Duration of pregnancy
Participants who conceive are followed throughout their pregnancy to monitor pregnancy outcomes and collect microbiome and metabolome data.
Multiple follow-up visits throughout pregnancy
Trial Site Locations
Total: 2 locations
1
Reproductive Medicine, Karolinska University Hospital
Stockholm, Huddinge, Sweden, 141 57
Not Yet Recruiting
2
Reproduktionscentrum Akademiska sjukhuset
Uppsala, Sweden, 751 85
Actively Recruiting
Research Team
L
Lars Holmgren, Professor
S
Sebastian Sebastian Brusell Gidlöf, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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