Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07532629

Microbiome and Metabolome Profiles in Couples Undergoing IVF and Reproductive Outcomes

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Infertility Abortion, Spontaneous Assisted Reproductive Technology Female Urogenital Diseases and Pregnancy Complications Genital Diseases Metabolome Microbiome Pregnancy Complications Pregnancy Loss, Early Urogenital Diseases

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Reproduktionsmottagning Malmö, Skånes universitetssjukhus, Malmö, Sweden

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. Number of Participants With Miscarriage Before 22 Weeks of Gestation

    Time frame: Up to 21 weeks and 6 days of gestation

    Pregnancy loss before 22 weeks of gestation identified through linkage with national pregnancy registers.

  2. Number of Participants With Preterm Birth Before 37 Completed Weeks of Gestation

    Time frame: At delivery

    Delivery before 37 completed weeks of gestation identified through national birth registers.

  3. Number of Participants With Preeclampsia

    Time frame: During pregnancy through 6 weeks postpartum

    Diagnosis of preeclampsia recorded in national health registers according to ICD codes.

  4. 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

    Relative abundance of prespecified microbial taxa measured in female reproductive tract samples collected at baseline using sequencing-based metagenomic profiling.

  5. Concentration of Prespecified Metabolites in Female Reproductive Tract Samples

    Time frame: Baseline, prior to initiation of IVF treatment

    Concentrations of prespecified metabolites measured in female reproductive tract samples collected at baseline using metabolomics analysis.

  6. Number of Participants With Clinical Pregnancy Confirmed by Ultrasound

    Time frame: 6 to 8 weeks after embryo transfer

    Presence of an intrauterine gestational sac with fetal heartbeat confirmed by ultrasound following embryo transfer.

  7. Number of Participants With Biochemical Pregnancy

    Time frame: 10 to14 days after embryo transfer

    Positive serum human chorionic gonadotropin (hCG) following embryo transfer without ultrasound-confirmed pregnancy.

  8. Sperm concentration

    Time frame: At oocyte retrieval, approximately 10 to 20 days after initiation of IVF stimulation

    Sperm concentration assessed according to WHO laboratory standards.

  9. 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

    Relative abundance of prespecified microbial taxa measured in seminal fluid samples collected from male partners using sequencing-based metagenomic profiling.

  10. Concentration of Prespecified Metabolites in Male Semen Samples

    Time frame: At oocyte retrieval, approximately 10 to 20 days after initiation of IVF stimulation

    Concentrations of prespecified metabolites measured in semen samples collected from male partners using metabolomics analysis.

  11. Fertilization Rate per Retrieved Mature Oocyte

    Time frame: Day 1 after oocyte retrieval

    Proportion of oocytes that are successfully fertilized following IVF or ICSI.

  12. Normal sperm morphology

    Time frame: At oocyte retrieval, approximately 10 to 20 days after initiation of IVF stimulation

    Percentage of sperm with normal morphology assessed according to WHO laboratory standards.

  13. Levels of Immune Markers in Female Blood Samples

    Time frame: Baseline (Day 0), prior to initiation of IVF stimulation

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Hanna Nilsson, PhD

CONTACT

[email protected]

Ola Larsson, PhD

CONTACT

[email protected]

+46 8 524 80000

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Official study title

Microbiome and Metabolome Profiles in Couples Undergoing IVF and Their Association With Reproductive Outcomes in a Prospective Longitudinal Cohort Study

Acronym: Mi IVF

Important dates

Study start
2022
Primary completion
2028
Study completion
2029
First posted
Apr 16, 2026
Registry last updated
Apr 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.