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Effect of Environmental Exposures on the Egg Fertilizing Ability of Human Sperm

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2002 by National Institute of Environmental Health Sciences (NIEHS).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Institute of Environmental Health Sciences (NIEHS)
ClinicalTrials.gov Identifier:
NCT00012480
First received: March 9, 2001
Last updated: June 23, 2005
Last verified: September 2002
  Purpose

Our data indicate that environmental exposure to the heavy metal lead are more widespread than currently appreciated and that such exposures are associated with the production of human male subfertility. Lead's effects are observed in male partners of infertile couples attending an IVF clinical, in men acting as semen donors in an artificial insemination program and in men representative of the general public. Our goal is to identify the mechanism(s) underlying lead's anti-fertility action.


Condition
Male Infertility
Testicular Diseases
Urologic and Male Genital Diseases
Lead Poisoning

Study Type: Observational
Study Design: Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Cross-Sectional
Official Title: Human Sperm Zona Acceptor: Environmental Effects

Resource links provided by NLM:


Further study details as provided by National Institute of Environmental Health Sciences (NIEHS):

Estimated Enrollment: 400
Study Start Date: August 2002
Estimated Study Completion Date: July 2006
Detailed Description:

Our goal is to understand how environmental and occupational exposures to heavy and transition metal ions injure the human male reproductive tract.

The American Urological Association and the American Society for Reproductive Medicine report that ~15% of couples (i.e., more than 6.1 million people in the U.S.) experience infertility at some time. The male is responsible for infertility of 20% of these couples and contributes to the infertility of another 30-40%. However, the cause(s) of male infertility in many cases is unknown. Our data suggest that lead exposures (in the air, in food and in drinking water) underlie a significant fraction of "unexplained" male infertility. We found that blood and seminal plasma lead levels were elevated in 22% of normospermic males from couples seeking infertility treatment, in 29% of semen donors participating in an artificial insemination program and in 23% of unselected semen donors answering an advertisement for research participation. These elevated lead levels were associated with decreased sperm fertility potential in IVF, in artificial insemination and in pregnancy by coitus. The negative effects of lead on sperm function was correlated with expression of specific forms of sperm ion channels (metal binding proteins that allow lead to enter cells), suggesting that such proteins serve as markers for susceptibility or resistance to the reproductive toxic effects of lead. Further, in cases in which human male lead levels changed markedly over time, there were corresponding changes in sperm ion channel, sperm function and sperm fertility potential. These changes were linked to changes in calcium modulated processes in human testis biopsies obtained from infertility patients and could be mimicked in testes of rats experimentally fed lead.

In the current study, we plan to identify changes in gene expression important to the production of the infertile state by comparing the genes expressed in the testis of control and lead exposed rats which are resistant or susceptible to lead. These findings will help to explain how lead exposure kill cells within the testis. We will then determine whether the same changes occur in human testis biopsies and ejaculated sperm from infertile males with high body burdens of lead. The expected outcome of this study is the identification of a possible mechanism explaining male infertility associated with low sperm counts or idiopathic male infertility, tools for diagnosis of male infertility and the hope for rationale treatment.

  Eligibility

Ages Eligible for Study:   21 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria
  • Otherwise healthy men seeking fertility evaluation, without history of urologic infections or varicocele.
  • Non-smokers.
  • Occupationally exposed to lead or not exposed to lead.
  • Otherwise healthy men undergoing testis biopsy for clinical assessment of spermatogenesis or for sperm retrieval prior to an attempt at assisted reproduction.
  • Otherwise healthy men providing semen specimens for clinical analysis prior to an attempt at assisted reproduction.
  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: NCT00012480

Contacts
Contact: Susan H Benoff, PhD 516-562-1121 sbenoff@nshs.edu
Contact: Colleen Millan, MA 516-562-4038 cmillan@nshs.edu

Locations
United States, California
University of Southern California Women's and Children's Hospital Not yet recruiting
Los Angeles, California, United States, 90033
Contact: Rebecca Z Sokol, MD    323-226-3091    rsokol@hsc.usc.edu   
Sub-Investigator: Rebecca Z Sokol, MD         
United States, New York
North Shore University Hospital Recruiting
Manhasset, New York, United States, 11030
Contact: Susan H Benoff, PhD    516-562-1121    sbenoff@nshs.edu   
Contact: Colleen Millan, MA    526-562-1049    cmillan@nshs.edu   
Principal Investigator: Susan H Benoff, PhD         
United States, Pennsylvania
Copper Hospital and Fertility Testing Laboratory and Sperm Bank Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Joel L Marmar, MD    609-963-3577    marmar-joel@cooperhealth.edu   
Sub-Investigator: Joel L Marmar, MD         
Sponsors and Collaborators
Investigators
Principal Investigator: Susan H Benoff, PhD North Shore University Hospital
  More Information

Publications:
Millan C, Sokol RZ, Shi Q, Hurley IR, Centola GM, Ilasi J, Rooney E, Benoff S. Lead induces epigenetic modification of rat testicular gene expression: a DNA microarray study. In: Robaire B, Chemes H, Morales CR, eds. Andrology in the 21st Century. Proceedings of the VII International Congress on Andrology. Short Communications. Englewood, New Jersey: Medimond Publishing Co. Inc. 2001:335-339.

ClinicalTrials.gov Identifier: NCT00012480     History of Changes
Other Study ID Numbers: 6100-CP-001
Study First Received: March 9, 2001
Last Updated: June 23, 2005
Health Authority: United States: Federal Government

Keywords provided by National Institute of Environmental Health Sciences (NIEHS):
Lead
Male infertility
Gene expression
Economics, Medical

Additional relevant MeSH terms:
Genital Diseases, Male
Infertility
Infertility, Male
Lead Poisoning
Testicular Diseases
Chemically-Induced Disorders
Endocrine System Diseases
Genital Diseases, Female
Gonadal Disorders
Poisoning

ClinicalTrials.gov processed this record on November 24, 2014