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NCT Number: NCT05179993

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Infertility treatment center Dortmund

Dortmund, North Rhine-Westphalia, 44135, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Microplastics

Other

Detection of microplastics as a yes/no value

Primary outcomes

  1. Detection of microplastics in human granulosa cells and in the Follicular fluid

    Time frame: 1 day (directly after oocyte pick-up)

    Detection of microplastics in human granulosa cells and in the Follicular fluid of women undergoing intracytoplasmic sperm injection (ICSI) treatment as a binary value (yes / no).

Sponsors and collaborators

Lead sponsor

Infertility Treatment Center Dortmund

Other

Collaborators

  • Ludwig-Maximilians - University of Munich

Registry information

Official study title

Detection of Microplastics in Human Granulosa Cells and in the Follicular Fluid of Women Undergoing Intracytoplasmic Sperm Injection (ICSI) Treatment

Acronym: MP2021

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Jan 6, 2022
Registry last updated
Mar 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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