Fertility Impact of Microplastics - Advancing Countermeasures and Tracking
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-55
SponsorUniversity of Kragujevac
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
Adults of reproductive age
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Clinical pregnancy rate
Clinical pregnancy defined as the presence of a gestational sac with fetal heartbeat confirmed by transvaginal ultrasound at 6-8 weeks of gestation, according to ICMART criteria.
Time frame
6-8 weeks after ART procedure2
Concentration of micro- and nanoplastics (MNPs) in reproductive biospecimens
Quantification of concentration MNPs in semen, follicular fluid, endometrial samples, stool, and serum using validated spectroscopic and microscopic methods, expressed as particle number and size distribution per sample volume.
Time frame
At baseline (time of sample collection)Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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