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

NCT05179993 | Active Not Recruiting

• 1 other identifier: Microplastic
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Female Infertility; Environmental Exposure

Keywords

Microplastics; Follicular Fluid; Granulosa Cells

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (1)

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

Other: Microplastics

Interventions

Microplastics OTHER

Detection of microplastics as a yes/no value

Study Group

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population is made up of patients from the Fertility Center Dortmund who have given their consent to the study after being informed by the attending physician.

You may qualify if:

• 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.

You may not qualify if:

• none

Sponsors & Collaborators

• Infertility Treatment Center Dortmund: lead
• Ludwig-Maximilians - University of Munich: collaborator

Study Sites (1)

Infertility treatment center Dortmund

Dortmund, North Rhine-Westphalia, 44135, Germany

Location

Biospecimen

Retention: SAMPLES WITH DNA

human granulosa cells and human follicular fluid of women undergoing ICSI Treatment

MeSH Terms

Conditions

Infertility, Female

Interventions

Microplastics

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Infertility

Intervention Hierarchy (Ancestors)

Plastics; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Stefan Dieterle, MD

  Infertility Treatment Center Dortmund

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2021
• First Posted: January 6, 2022
• Study Start: September 1, 2022
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)