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

Environmental Exposure Clinical Trial

— MP2021  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05179993
• Other study ID #: Microplastic
• Status: Recruiting
• Start date: September 1, 2022
• Est. completion date: December 31, 2025

Study information

• Verified date: February 2024
• Source: Infertility Treatment Center Dortmund
• Contact: Stefan Dieterle, MD
• Phone: 00492315575450
• Email: dieterle[@]kinderwunschzentrum.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2025
• Est. primary completion date: March 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Environmental Exposure
• Female Infertility
• Infertility
• Infertility, Female

Intervention

Other:
• Microplastics
Detection of microplastics as a yes/no value

Locations

Country	Name	City	State
Germany	Infertility treatment center Dortmund	Dortmund	NRW

Sponsors (2)

Lead Sponsor	Collaborator
Infertility Treatment Center Dortmund	Ludwig-Maximilians - University of Munich

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Detection of microplastics in human granulosa cells and in the Follicular fluid	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).	1 day (directly after oocyte pick-up)