InfertilityMi IVFNCT07532629
Microbiome and Metabolome Profiles in Couples Undergoing IVF and Reproductive Outcomes
An observational study of Infertility and Assisted Reproductive Technology, run by Karolinska Institutet at 3 sites in Sweden.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Infertility, Assisted Reproductive Technology, Pregnancy Complications
- How many people
- 1,000 participants
- Where
- 3 sitesSweden
- Study dates
- 10 Jun 2022to 1 Mar 2029
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Hanna Nilsson, PhD contact
Sweden3 sites, 3 recruiting
- Recruiting
Reproduktionsmottagning Malmö, Skånes universitetssjukhus
Malmö
Margareta Kitlinski, MD, PhD, margareta.kitlinski@skane.se
Margareta Kitlinski, MD, PhD
- Recruiting
Karolinska Universitetssjukhuset
Stockholm, 146 32
Hana Shabana, MD, +46721775326, hana.shabana@ki.se
Kenny A Rodriguez-Wallberg, MD, PhD, +46721775326, hana.shabana@ki.se
- Recruiting
Reproduktionscenter, Akademiska sjukuhset
Uppsala
Farnaz Bazargani, MD, farnaz.bazargani@akademiska.se
Farnaz Bazargani, MD
About this study
Official title: Microbiome and Metabolome Profiles in Couples Undergoing IVF and Their Association With Reproductive Outcomes in a Prospective Longitudinal Cohort Study
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.
Read the 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.
- Conditions
- Infertility, Assisted Reproductive Technology, Pregnancy Complications, Pregnancy Loss, Early, Metabolome, Microbiome
- Keywords
- IVF, Microbiome, Metabolome, Male fertility, Pregnancy outcome
- Medical subject headings
- Infertility, Pregnancy Complications, Abortion, Spontaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Live Birth
Delivery of a live-born infant after IVF treatment, identified through linkage with national health registers.
Measured: Through delivery, up to 12 months after embryo transfer
Secondary outcomes (13)
Number of Participants With Miscarriage Before 22 Weeks of Gestation
Pregnancy loss before 22 weeks of gestation identified through linkage with national pregnancy registers.
Measured: 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.
Measured: At delivery
Number of Participants With Preeclampsia
Diagnosis of preeclampsia recorded in national health registers according to ICD codes.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 10 to14 days after embryo transfer
Sperm concentration
Sperm concentration assessed according to WHO laboratory standards.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 1 after oocyte retrieval
Normal sperm morphology
Percentage of sperm with normal morphology assessed according to WHO laboratory standards.
Measured: 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.
Measured: Baseline (Day 0), prior to initiation of IVF stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2026
- Study start10 Jun 2022
- Primary completion20 Aug 2028 (estimated)
- Study completion1 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies 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
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kenny Rodriguez-Wallberg, Karolinska Institutet
- Investigators
- Kenny A. Rodriguez-Wallberg, MD., PhD, Principal investigator, Oncology-pathology, Karolinska InstitutetHana Shabana, MD, PhD candidate, Study director, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07532629
- Sponsor's protocol ID
- 2024-07146-02
- Acronym
- Mi IVF
- Status last verified
- Apr 2026
- First submitted
- 26 Mar 2026
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microbiome and Metabolome Profiles in Couples Undergoing IVF and Their Association With Reproductive Outcomes in a Prospective Longitudinal Cohort Study
- ClinicalTrials.gov ID
- NCT07532629
- Acronym / sponsor ID
- Mi IVF / 2024-07146-02
- Conditions
- Infertility, Assisted Reproductive Technology, Pregnancy Complications, Pregnancy Loss, Early, Metabolome, Microbiome
- Keywords
- IVF, Microbiome, Metabolome, Male fertility, Pregnancy outcome
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 10 Jun 2022 (actual)
- Primary completion
- 20 Aug 2028 (estimated)
- Study completion
- 1 Mar 2029 (estimated)
- First posted
- 16 Apr 2026 (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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of Participants with Live Birth
Time frame: Through delivery, up to 12 months after embryo transfer
Delivery of a live-born infant after IVF treatment, identified through linkage with national health registers.
13 secondary outcomes
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
Levels of Immune Markers in Female Blood Samples
Time frame: Baseline (Day 0), prior to initiation of IVF stimulation
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 16 Apr 2026.
- Individual participant dataSharing planned: Undecided. 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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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.
Hanna Nilsson, PhD contact
Kenny A. Rodriguez-Wallberg, MD., PhD principal investigator
Oncology-pathology, Karolinska Institutet
Hana Shabana, MD, PhD candidate study director
Karolinska Institutet
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility and Assisted Reproductive Technology, run by Karolinska Institutet at 3 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 3 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 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 Ola Larsson, PhD (+46 8 524 80000, ola.larsson@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Live Birth (time frame: Through delivery, up to 12 months after embryo transfer). 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 16 Apr 2026.