Fertility Impact of Microplastics - Advancing Countermeasures and Tracking

NCT07562958 | Not Yet Recruiting

• 1 other identifier: FERTIMPACT - 101289228-2
• Study Type: observational
• Target: 1,000
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Microplastics Exposure; Infertility; Fertility

Keywords

Fertility; microplastics; IVF; micronanoplastics

Outcome Measures

Primary Outcomes (2)

• 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.

  6-8 weeks after ART procedure

• 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.

  At baseline (time of sample collection)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Adults of reproductive age

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Kragujevac: lead

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood, stool, semen, follicular fluid, endometrial sample

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Design

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

Study Record Dates

• First Submitted: April 11, 2026
• First Posted: May 1, 2026
• Study Start (Estimated): September 1, 2027
• Primary Completion (Estimated): September 1, 2029
• Study Completion (Estimated): October 1, 2030
• Last Updated: May 1, 2026

Record last verified: 2026-04