Microbiome and Metabolome Profiles in Couples Undergoing IVF and Reproductive Outcomes
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
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Infertility, Assisted Reproductive Technology, Pregnancy Complications, Pregnancy Loss, Early. Basic parameters: 18 years — 40 years · All.
- 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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Official title
Microbiome and Metabolome Profiles in Couples Undergoing IVF and Their Association With Reproductive Outcomes in a Prospective Longitudinal Cohort Study
Overview
This prospective observational cohort study investigates the role of the microbiome and metabolome in couples undergoing in vitro fertilization. Biological samples will be collected from both female and male partners, including semen, vaginal, and blood samples, to characterize microbial composition and metabolic profiles. The study aims to examine how these biological profiles are associated with reproductive outcomes such as fertilization, pregnancy, miscarriage, and live birth. Participants will be followed longitudinally, and reproductive and obstetric outcomes will be obtained through linkage with national health registers.
Detailed description
Infertility affects a substantial proportion of couples worldwide, and in vitro fertilization (IVF) is an important treatment option for many individuals experiencing infertility. Increasing evidence suggests that the human microbiome and metabolome may play a role in reproductive health and fertility outcomes. However, the contribution of microbial communities and metabolic profiles in both female and male partners to IVF outcomes remains insufficiently understood.
This prospective observational cohort study aims to investigate the microbiome and metabolome profiles in couples undergoing IVF treatment and their association with reproductive and obstetric outcomes. Heterosexual couples undergoing IVF treatment at participating fertility clinics will be recruited. Biological samples will be collected from both partners, including semen samples from male partners and vaginal and blood samples from female partners. These samples will be stored and analyzed using sequencing-based microbiome profiling and metabolomic analyses.
The study will evaluate microbial composition, diversity, and metabolic signatures in relation to fertility parameters such as semen quality, fertilization rate, embryo development, and clinical pregnancy. Participants will be followed longitudinally to assess reproductive outcomes including miscarriage, preterm birth, preeclampsia, and live birth. Outcome data will be obtained through clinical records and linkage with national health registers.
The overall aim of the study is to improve the understanding of how microbiome and metabolome profiles in both partners may influence reproductive success and pregnancy outcomes in couples undergoing IVF.
Primary outcome measures
- Number of Participants with Live Birth [Time frame: Through delivery, up to 12 months after embryo transfer]
Secondary outcome measures (12)
- Number of Participants With Miscarriage Before 22 Weeks of Gestation [Time frame: Up to 21 weeks and 6 days of gestation]
- Number of Participants With Preterm Birth Before 37 Completed Weeks of Gestation [Time frame: At delivery]
- Number of Participants With Preeclampsia [Time frame: During pregnancy through 6 weeks postpartum]
- Relative Abundance of Prespecified Microbial Taxa in Female Reproductive Tract Samples [Time frame: Time Frame: Baseline (Day 0, prior to initiation of IVF stimulation); early pregnancy confirmation visit (gestational weeks 7 to 9); and at miscarriage, if applicable, during pregnancy up to gestational age 21 weeks 6 days]
- Concentration of Prespecified Metabolites in Female Reproductive Tract Samples [Time frame: Baseline, prior to initiation of IVF treatment]
- Number of Participants With Clinical Pregnancy Confirmed by Ultrasound [Time frame: 6 to 8 weeks after embryo transfer]
- Number of Participants With Biochemical Pregnancy [Time frame: 10 to14 days after embryo transfer]
- Sperm concentration [Time frame: At oocyte retrieval, approximately 10 to 20 days after initiation of IVF stimulation]
- Relative Abundance of Prespecified Microbial Taxa in Seminal Fluid Samples [Time frame: At oocyte retrieval, approximately 10 to 20 days after initiation of IVF stimulation]
- Concentration of Prespecified Metabolites in Male Semen Samples [Time frame: At oocyte retrieval, approximately 10 to 20 days after initiation of IVF stimulation]
- Fertilization Rate per Retrieved Mature Oocyte [Time frame: Day 1 after oocyte retrieval]
- Normal sperm morphology [Time frame: At oocyte retrieval, approximately 10 to 20 days after initiation of IVF stimulation]
Eligibility criteria
Inclusion criteria
- Women aged 18 to 40 years at enrolment.
- Men aged between 18 to 56 years at enrolment.
- Couples planning to undergo IVF treatment at a participating centre.
- Sufficient understanding of spoken and written Swedish or English to provide informed consent and complete the web-based questionnaire.
Exclusion criteria
- Pregnancy at the time of enrolment (confirmed or suspected).
- Recent systemic antibiotic use within the past 4 weeks
- Active vaginal or genital tract infection at the time of sampling
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 · 3 centers
- Reproduktionsmottagning Malmö, Skånes universitetssjukhus — Malmö
- Karolinska Universitetssjukhuset — Stockholm
- Reproduktionscenter, Akademiska sjukuhset — Uppsala
Identifiers
NCT: NCT07532629 · 2024-07146-02