Fertility Impact of Microplastics - Advancing Countermeasures and Tracking (NCT07562958) | Clinical Trial Compass
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 range
18 Years – 55 Years
Sex
ALL
See this in plain English?
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Clinical pregnancy rate
Timeframe: 6-8 weeks after ART procedure
2
Concentration of micro- and nanoplastics (MNPs) in reproductive biospecimens
Timeframe: At baseline (time of sample collection)