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

Recruiting

• Conditions: Female Infertility; Environmental Exposure
• Interventions: Other: Microplastics

• Registration Number: NCT05179993
• Lead Sponsor: Infertility Treatment Center Dortmund

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2021-12-17
• Study First Submitted QC: 2021-12-17
• Study First Posted: 2022-01-06
• Study Start: 2022-09-01
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-10
• Last Update Posted: 2025-03-12
• Primary Completion: 2026-03-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Study Group	Microplastics	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

Primary Outcome Measures

Name	Time	Method
Detection of microplastics in human granulosa cells and in the Follicular fluid	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).

Trial Locations

Locations (1)

Infertility treatment center Dortmund; 🇩🇪 Dortmund, NRW, Germany