Not Yet RecruitingNot Applicable

Fertility Impact of Microplastics - Advancing Countermeasures and Tracking

1,000 participantsStarted 2027-09

Plain-language summary

FERTIMPACT is a prospective clinical study based on the hypothesis that exposure to micro- and nanoplastics (MNPs) is associated with impaired reproductive function. The study will quantify MNPs in human reproductive biospecimens (semen, follicular fluid, endometrial samples, stool and serum) and evaluate their association with clinically relevant fertility parameters, including semen, follicular fluid, and endometrial samples quality, and assisted reproductive technology (ART) outcomes. By integrating biomonitoring with standardized clinical assessment, the study aims to provide robust evidence on exposure-effect relationships in real-world populations undergoing infertility evaluation. This will contribute to improved understanding of environmental determinants of reproductive health and support future risk assessment strategies.

Who can participate

Age range18 Years – 55 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Men: 18-55 years and women: 18-45 years (premenopausal). * Residence: ≥ 2 years in the participating region. * Ability to give informed consent and complete questionnaires (diet, lifestyle, occupational exposure). * Willingness to provide required samples: semen, serum, stool for men and for women serum, stool, follicular fluid and endometrial sample. * Availability for study visits and compliance with pre-analytical rules: Abstinence 2-7 days before semen collection and timed sampling in women (e.g., follicular phase or per protocol). * For patient cohort: diagnosed reproductive disorder per site SOPs (e.g., male factor infertility, endometriosis, diminished ovarian reserve). * For control cohort: no known infertility diagnosis; trying to conceive or healthy volunteers. * Necessary for all participants will be possess the ability to understand the information contained in the "informed consent" document. Exclusion Criteria: * Pregnancy or lactation. * Acute febrile illness or active urogenital/reproductive tract infection in the last 4 weeks. * Systemic therapies likely to confound biomarkers within prespecified windows: chemotherapy/radiotherapy (past 12 months), high-dose corticosteroids/immunosuppressants (past 3 months), hormonal stimulation outside scheduled ART cycles per protocol. * Substance abuse (investigator judgment) impeding consent/compliance.

What they're measuring

Clinical pregnancy rate

Timeframe: 6-8 weeks after ART procedure

Concentration of micro- and nanoplastics (MNPs) in reproductive biospecimens

Timeframe: At baseline (time of sample collection)

Trial details

NCT IDNCT07562958

SponsorUniversity of Kragujevac

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2029-09