Analysis of Toxins in Follicle Fluid

NCT01385605 | Completed

• 1 other identifier: Toxins FF 2015
• Study Type: observational
• Target: 210
• Locations: 1 country
• Sites: 1

Brief Summary

Environmental pollutants might be jointly responsible for increase of infertility among women. Especially endocrin active substances seem to be of particular importance. These substances are chemicals which interfere with the physiological system of humans and animals. They have a negative impact on the endocrine system and disturb the functions of organs whose hormones regulate the male and female reproductive system. It is known that exposition to these chemicals lead to subfertility, infertility, raised abortions, birth defects and ovarian malfunction. Additionally it was shown that human embryos have a decreased cleavage rate after IVF when developing from oocytes with elevated concentrations of environmental pollutants. In this study the main focus concentrates on Nonylphenols (NP). Follicular fluids of women with subfertility will be analyzed by a newly developed principle including HPLC and NMR-Spectroscopy. This enables quantitative and qualitative analysis of enantiomers of NP. The results will allow risk estimations for several endocrine active substances, especially NP. Additionally conclusions concerning the correlation between thes substances and subfertility can be drawn.

Conditions

Environmental Exposure to Harmful Algae and Toxins; Female Subfertility

Outcome Measures

Primary Outcomes (1)

• Pregnancy

  14 days after ICSI treatment

Study Arms (1)

female patients

ICSI treatment because of male subfertility

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

female patients seeking ICSI treatment because of male subfertiliy

You may qualify if:

• healthy females without sterility factors

You may not qualify if:

• job-related exposition to pollutants
• low responder

Sponsors & Collaborators

• Infertility Treatment Center Dortmund: lead
• TU Dortmund University: collaborator
• Ferring Pharmaceuticals: collaborator

Study Sites (1)

Infertility treatment center Dortmund

Dortmund, North Rhine-Westphalia, 44135, Germany

Location

Related Publications (1)

• Bullach A, Trapphoff T, Zuhlke S, Spiteller M, Dieterle S. Impact of Nonylphenols and Polyhalogenated Compounds in Follicular Fluid on the Outcome of Intracytoplasmic Sperm Injection. Reprod Sci. 2021 Aug;28(8):2118-2128. doi: 10.1007/s43032-021-00472-y. Epub 2021 Feb 23.

  PMID: 33620705 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

follicular fluid

MeSH Terms

Conditions

Infertility, Female

Condition Hierarchy (Ancestors)

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

Study Officials

• Stefan Dieterle

  Infertility Treatment Center Dortmund

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: June 29, 2011
• First Posted: June 30, 2011
• Study Start: August 1, 2015
• Primary Completion: June 30, 2020
• Study Completion: February 23, 2021
• Last Updated: March 8, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)