NCT00012480

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2002

Longer than P75 for all trials

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 9, 2001

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 12, 2001

Completed
1.4 years until next milestone

Study Start

First participant enrolled

August 1, 2002

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
Last Updated

April 15, 2015

Status Verified

April 1, 2015

Enrollment Period

4.9 years

First QC Date

March 9, 2001

Last Update Submit

April 14, 2015

Conditions

Male InfertilityTesticular DiseasesUrologic and Male Genital DiseasesLead Poisoning

Keywords

LeadMale infertilityGene expressionEconomics, Medical

Eligibility Criteria

Age21 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)
* 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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (3)

University of Southern California Women's and Children's Hospital

Los Angeles, California, 90033, United States

Location

North Shore University Hospital

Manhasset, New York, 11030, United States

Location

Copper Hospital and Fertility Testing Laboratory and Sperm Bank

Philadelphia, Pennsylvania, 19107, United States

Location

Related Publications (5)

  • Benoff S, Cooper GW, Centola GM, Jacob A, Hershlag A, Hurley IR. Metal ions and human sperm mannose receptors. Andrologia. 2000 Sep;32(4-5):317-29. doi: 10.1046/j.1439-0272.2000.00401.x.

    PMID: 11021525BACKGROUND

  • Benoff S, Jacob A, Hurley IR. Male infertility and environmental exposure to lead and cadmium. Hum Reprod Update. 2000 Mar-Apr;6(2):107-21. doi: 10.1093/humupd/6.2.107.

    PMID: 10782569BACKGROUND

  • 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.

    BACKGROUND

  • Benoff S, Centola GM, Millan C, Napolitano B, Marmar JL, Hurley IR. Increased seminal plasma lead levels adversely affect the fertility potential of sperm in IVF. Hum Reprod. 2003 Feb;18(2):374-83. doi: 10.1093/humrep/deg020.

    PMID: 12571177BACKGROUND

  • Benoff S, Cooper GW, Paine T, Hurley IR, Napolitano B, Jacob A, Scholl GM, Hershlag A. Numerical dose-compensated in vitro fertilization inseminations yield high fertilization and pregnancy rates. Fertil Steril. 1999 Jun;71(6):1019-28. doi: 10.1016/s0015-0282(99)00136-3.

    PMID: 10360904BACKGROUND

MeSH Terms

Conditions

Infertility, MaleTesticular DiseasesGenital Diseases, MaleLead Poisoning

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital DiseasesInfertilityMale Urogenital DiseasesGonadal DisordersEndocrine System DiseasesHeavy Metal PoisoningPoisoningChemically-Induced Disorders

Study Officials

  • Susan H Benoff, PhD

    North Shore University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

March 9, 2001

First Posted

March 12, 2001

Study Start

August 1, 2002

Primary Completion

July 1, 2007

Study Completion

July 1, 2007

Last Updated

April 15, 2015

Record last verified: 2015-04

Locations

US(3)