Environmental Pollutants Relating to Human Subfertility

This study is currently recruiting participants.

Verified April 2013 by Infertility Treatment Center Dortmund

Sponsor:

Information provided by (Responsible Party):

Prof. Dr. Stefan Dieterle, Infertility Treatment Center Dortmund

ClinicalTrials.gov Identifier:

NCT01385605

First received: June 29, 2011

Last updated: April 3, 2013

Last verified: April 2013

History of Changes

Purpose

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.

Condition
Environmental Pollutants in Follicular Fluids Female Subfertility IVF

Study Type:	Observational
Official Title:	Analysis of Environmental Pollutants in Follicular Fluid of Women With Subfertility

Resource links provided by NLM:

MedlinePlus related topics: Infertility

U.S. FDA Resources

Further study details as provided by Infertility Treatment Center Dortmund:

Biospecimen Retention: Samples Without DNA

follicular fluid

Estimated Enrollment:	250
Study Start Date:	September 2010
Estimated Study Completion Date:	September 2013
Estimated Primary Completion Date:	July 2013 (Final data collection date for primary outcome measure)

Groups/Cohorts
female patients ICSI treatment because of male subfertility

Eligibility

Ages Eligible for Study:	18 Years to 39 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

female patients seeking ICSI treatment because of male subfertiliy

Criteria

Inclusion Criteria:

healthy females without sterility factors

Exclusion Criteria:

job-related exposition to pollutants
low responder

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01385605

Contacts

Contact: Stefan Dieterle

00492315575450

dieterle@ivf-dortmund.de

Locations

Germany
Infertility treatment center Dortmund	Recruiting
Dortmund, NRW, Germany, 44135
Contact: Stefan Dieterle 00492315575450
Principal Investigator: Stefan Dieterle

Sponsors and Collaborators

Infertility Treatment Center Dortmund

Investigators

Principal Investigator:

Stefan Dieterle

Infertility Treatment Center Dortmund

More Information

No publications provided

Responsible Party:	Prof. Dr. Stefan Dieterle, Prof. Dr. Dieterle, Infertility Treatment Center Dortmund
ClinicalTrials.gov Identifier:	NCT01385605 History of Changes
Other Study ID Numbers:	Pollutants FF 2010
Study First Received:	June 29, 2011
Last Updated:	April 3, 2013
Health Authority:	Germany: Ethics Commission

Additional relevant MeSH terms:

Infertility, Female
Infertility
Genital Diseases, Female
Genital Diseases, Male

ClinicalTrials.gov processed this record on May 23, 2013

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