Environmental Pollutants Relating to Human Subfertility

This study has been completed.
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: March 24, 2015
Last verified: March 2015
  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:


Further study details as provided by Infertility Treatment Center Dortmund:

Primary Outcome Measures:
  • Pregnancy [ Time Frame: 14 days after ICSI treatment ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

follicular fluid


Enrollment: 250
Study Start Date: September 2010
Study Completion Date: March 2015
Primary Completion Date: March 2015 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Germany
Infertility treatment center Dortmund
Dortmund, NRW, Germany, 44135
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: March 24, 2015
Health Authority: Germany: Ethics Commission

Additional relevant MeSH terms:
Infertility
Genital Diseases, Female
Genital Diseases, Male

ClinicalTrials.gov processed this record on May 31, 2015