Detection of Microplastics in Human Granulosa Cells and in the Follicular Fluid of Women Undergoing ICSI Treatment

NCT ID: NCT05179993

Last Updated: 2025-03-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-09-01

Study Completion Date

2026-12-31

Brief Summary

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Plastic products have been used ubiquitously in the modern world for many decades - for example as packaging materials, textile fibers or molded parts. The general use and especially the improper disposal lead to enormous environmental pollution almost everywhere on earth.

Microplastics mainly originate from fragmentation of larger plastic objects or can be produced directly for the use in e.g. cosmetics or industrial dyes.

Microplastics have already been detected in fresh- and seawater, soil, food, but also in human blood and urine. The accumulation of microplastics in ovarian and testicular tissue in humans has not yet been investigated.

Detailed Description

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Plastic products have been used ubiquitously in the modern world for many decades - for example as packaging materials, textile fibers or molded parts. The general use and especially the improper disposal lead to enormous environmental pollution almost everywhere on earth. In particular microplastics, by definition plastic particles with a diameter of less than 5mm, could pose a hazard to animals, humans and nature. Microplastics mainly originate from fragmentation of larger plastic objects or can be produced directly for the use in e.g. cosmetics or industrial dyes.

Microplastics have already been detected in fresh- and seawater, soil, food, but also in human blood and urine. The accumulation of microplastics in ovarian and testicular tissue in humans has not yet been investigated.

The presence of microplastics in reproductive tissue could also have negative consequences for reproduction. In oysters, waterfleas and mice, an impairment of reproduction due to the bioaccumulation of microplastics has already been described. Overall, current understanding of the effects of microplastics on human fertility and overall mammalian health is very limited.

Samples will be analyzed using Raman spectroscopy and scanning electron microscopy.

Conditions

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Female Infertility Environmental Exposure

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Study Group

Proof of principle Study group: detection of microplastics in human granulosa cells and in the follicular fluid of women undergoing intracytoplasmic sperm injection (ICSI) treatment

Microplastics

Intervention Type OTHER

Detection of microplastics as a yes/no value

Interventions

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Microplastics

Detection of microplastics as a yes/no value

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* The patients to be included should be ≥18 years of age undergoing an intracytoplasmic sperm injection (ICSI) treatment. There is no upper limit for patient age.

Exclusion Criteria

* none
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Ludwig-Maximilians - University of Munich

OTHER

Sponsor Role collaborator

Infertility Treatment Center Dortmund

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stefan Dieterle, MD

Role: PRINCIPAL_INVESTIGATOR

Infertility Treatment Center Dortmund

Locations

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Infertility treatment center Dortmund

Dortmund, North Rhine-Westphalia, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Stefan Dieterle, MD

Role: CONTACT

00492315575450

Tom Trapphoff, PhD

Role: CONTACT

00492315575450

Facility Contacts

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Stefan Dieterle

Role: primary

00492315575450

Other Identifiers

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Microplastic

Identifier Type: -

Identifier Source: org_study_id

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