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.
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.
Study Type
OBSERVATIONAL
Enrollment
1,000
Reproduktionsmottagning Malmö, Skånes universitetssjukhus
Malmo, Sweden
RECRUITINGKarolinska Universitetssjukhuset
Stockholm, Sweden
RECRUITINGReproduktionscenter, Akademiska sjukuhset
Uppsala, Sweden
RECRUITINGNumber of Participants with Live Birth
Delivery of a live-born infant after IVF treatment, identified through linkage with national health registers.
Time frame: Through delivery, up to 12 months after embryo transfer
Number of Participants With Miscarriage Before 22 Weeks of Gestation
Pregnancy loss before 22 weeks of gestation identified through linkage with national pregnancy registers.
Time frame: Up to 21 weeks and 6 days of gestation
Number of Participants With Preterm Birth Before 37 Completed Weeks of Gestation
Delivery before 37 completed weeks of gestation identified through national birth registers.
Time frame: At delivery
Number of Participants With Preeclampsia
Diagnosis of preeclampsia recorded in national health registers according to ICD codes.
Time frame: During pregnancy through 6 weeks postpartum
Relative Abundance of Prespecified Microbial Taxa in Female Reproductive Tract Samples
Relative abundance of prespecified microbial taxa measured in female reproductive tract samples collected at baseline using sequencing-based metagenomic profiling.
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
Concentrations of prespecified metabolites measured in female reproductive tract samples collected at baseline using metabolomics analysis.
Time frame: Baseline, prior to initiation of IVF treatment
Number of Participants With Clinical Pregnancy Confirmed by Ultrasound
Presence of an intrauterine gestational sac with fetal heartbeat confirmed by ultrasound following embryo transfer.
Time frame: 6 to 8 weeks after embryo transfer
Number of Participants With Biochemical Pregnancy
Positive serum human chorionic gonadotropin (hCG) following embryo transfer without ultrasound-confirmed pregnancy.
Time frame: 10 to14 days after embryo transfer
Sperm concentration
Sperm concentration assessed according to WHO laboratory standards.
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
Relative abundance of prespecified microbial taxa measured in seminal fluid samples collected from male partners using sequencing-based metagenomic profiling.
Time frame: At oocyte retrieval, approximately 10 to 20 days after initiation of IVF stimulation
Concentration of Prespecified Metabolites in Male Semen Samples
Concentrations of prespecified metabolites measured in semen samples collected from male partners using metabolomics analysis.
Time frame: At oocyte retrieval, approximately 10 to 20 days after initiation of IVF stimulation
Fertilization Rate per Retrieved Mature Oocyte
Proportion of oocytes that are successfully fertilized following IVF or ICSI.
Time frame: Day 1 after oocyte retrieval
Normal sperm morphology
Percentage of sperm with normal morphology assessed according to WHO laboratory standards.
Time frame: At oocyte retrieval, approximately 10 to 20 days after initiation of IVF stimulation
Levels of Immune Markers in Female Blood Samples
Levels of immune markers measured in blood samples collected from female participants at baseline using laboratory-based immunologic assays. Associations with female reproductive tract microbiome composition and metabolomic profiles will be evaluated in exploratory analyses.
Time frame: Baseline (Day 0), prior to initiation of IVF stimulation
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