Microbiome and Metabolome Profiles in Couples Undergoing IVF and Reproductive Outcomes

NCT07532629 | Recruiting

• 1 other identifier: 2024-07146-02
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 3

Brief 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 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.

Conditions

Infertility; Assisted Reproductive Technology; Pregnancy Complications; Pregnancy Loss, Early; Metabolome; Microbiome

Keywords

IVF; Microbiome; Metabolome; Male fertility; Pregnancy outcome

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (13)

• Number of Participants With Miscarriage Before 22 Weeks of Gestation

  Up to 21 weeks and 6 days of gestation

• Number of Participants With Preterm Birth Before 37 Completed Weeks of Gestation

  At delivery

• Number of Participants With Preeclampsia

  During pregnancy through 6 weeks postpartum

• Relative Abundance of Prespecified Microbial Taxa in Female Reproductive Tract Samples

  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

  Baseline, prior to initiation of IVF treatment

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (3)

Reproduktionsmottagning Malmö, Skånes universitetssjukhus

Malmo, Sweden

RECRUITING

Karolinska Universitetssjukhuset

Stockholm, 146 32, Sweden

RECRUITING

Reproduktionscenter, Akademiska sjukuhset

Uppsala, Sweden

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

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.

MeSH Terms

Conditions

Infertility; Pregnancy Complications; Abortion, Spontaneous

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications

Study Officials

• Kenny A. Rodriguez-Wallberg, MD., PhD

  Oncology-pathology, Karolinska Institutet

  PRINCIPAL INVESTIGATOR

• Hana Shabana, MD, PhD candidate

  Karolinska Institutet

  STUDY DIRECTOR

Central Study Contacts

Ola Larsson, PhD

CONTACT

+46 8 524 80000; ola.larsson@ki.se

Hanna Nilsson, PhD

CONTACT

hanna.nilsson@ki.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD., Professor

Study Record Dates

• First Submitted: March 26, 2026
• First Posted: April 16, 2026
• Study Start: June 10, 2022
• Primary Completion (Estimated): August 20, 2028
• Study Completion (Estimated): March 1, 2029
• Last Updated: April 16, 2026

Record last verified: 2026-04

Locations

SE (3)