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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Couples Undergoing IVF Treatment | Prospective cohort of couples undergoing in vitro fertilization (IVF) treatment at participating in a multicenter fertility clinics in Sweden. Biological samples are collected from both partners for microbiome and metabolome profiling, and participants are followed longitudinally for reproductive and obstetric outcomes through linkage with national health registers. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Live Birth | Delivery of a live-born infant after IVF treatment, identified through linkage with national health registers. | Through delivery, up to 12 months after embryo transfer |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Miscarriage Before 22 Weeks of Gestation | Pregnancy loss before 22 weeks of gestation identified through linkage with national pregnancy registers. | Up to 21 weeks and 6 days of gestation |
| Number of Participants With Preterm Birth Before 37 Completed Weeks of Gestation |
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Inclusion Criteria:
Exclusion Criteria:
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Couples undergoing in vitro fertilization (IVF) treatment at participating fertility clinics in Sweden. Eligible couples are consecutively recruited at the time of IVF treatment initiation and followed prospectively for reproductive outcomes through linkage with national health registers.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ola Larsson, PhD | Contact | +46 8 524 80000 | ola.larsson@ki.se | |
| Hanna Nilsson, PhD | Contact | hanna.nilsson@ki.se |
| Name | Affiliation | Role |
|---|---|---|
| Kenny A. Rodriguez-Wallberg, MD., PhD | Oncology-pathology, Karolinska Institutet | Principal Investigator |
| Hana Shabana, MD, PhD candidate | Karolinska Institutet | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Reproduktionsmottagning Malmö, Skånes universitetssjukhus | Recruiting | Malmö | Sweden |
Individual participant data may be shared with qualified researchers upon reasonable request after publication of the study results. Data sharing will be subject to ethical approval, institutional policies, and applicable data protection regulations.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 5, 2026 | Apr 11, 2026 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D007246 | Infertility |
| D011248 | Pregnancy Complications |
| D000022 | Abortion, Spontaneous |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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Biological samples will be collected from both female and male partners undergoing IVF treatment, including semen samples, vaginal samples, and blood samples. Samples will be stored for microbiome and metabolome analyses, including extraction and sequencing of microbial DNA and metabolomic profiling.
Delivery before 37 completed weeks of gestation identified through national birth registers. |
| At delivery |
| Number of Participants With Preeclampsia | Diagnosis of preeclampsia recorded in national health registers according to ICD codes. | 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: 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. | 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. | 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. | 10 to14 days after embryo transfer |
| Sperm concentration | Sperm concentration assessed according to WHO laboratory standards. | 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. | 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. | 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. | Day 1 after oocyte retrieval |
| Normal sperm morphology | Percentage of sperm with normal morphology assessed according to WHO laboratory standards. | 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. | Baseline (Day 0), prior to initiation of IVF stimulation |
| Karolinska Universitetssjukhuset | Recruiting | Stockholm | 146 32 | Sweden |
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| Reproduktionscenter, Akademiska sjukuhset | Recruiting | Uppsala | Sweden |
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