Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Environment and Reproductive Health (EARTH)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by National Institute of Environmental Health Sciences (NIEHS)
Sponsor:
Collaborator:
Massachusetts General Hospital
Information provided by (Responsible Party):
Russ Hauser, National Institute of Environmental Health Sciences (NIEHS)
ClinicalTrials.gov Identifier:
NCT00011713
First received: February 27, 2001
Last updated: October 3, 2014
Last verified: October 2014
  Purpose

The purpose of the study is to investigate the relationship between environmental agents and reproductive health. Environmental agents of interest include exposure to chemicals such as polychlorinated biphenyls (PCBs), flame retardants, dioxins, bisphenol A, phthalates, pesticides, and metals like lead and cadmium. We are also interested in the relationship between reproductive health and lifestyle risk factors, such as exposure to environmental tobacco smoke. Enrollees are asked to participate in this study because they and their partner are patients of the MGH Fertility Center, trying to get pregnant, either naturally or by undergoing Intrauterine Insemination (IUI) and/or In Vitro Fertilization (IVF).


Condition Intervention
Infertility
Other: Completion questionnaires/providing biological samples

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Human Exposure to Bisphenol A, Phthalates and Fertility, Pregnancy Outcomes.

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Paternal Exposure to Environmental Chemicals [ Time Frame: 2019 ] [ Designated as safety issue: No ]
    To determine the association of a mixture of paternal urinary concentrations of phthalate metabolites, BPA and parabens with the primary outcomes of implantation failure and live birth, and the secondary outcomes of chemical pregnancy (with no subsequent clinical pregnancy) and spontaneous abortion.


Secondary Outcome Measures:
  • Maternal Exposure to Environmental Chemicals [ Time Frame: 2019 ] [ Designated as safety issue: No ]
    To determine the association of a mixture of maternal urinary concentrations of phthalate metabolites, BPA and parabens with implantation failure and live birth rate, and the secondary outcomes of chemical pregnancy and spontaneous abortion.


Biospecimen Retention:   Samples With DNA

Whole blood, urine, semen, follicular fluid, amniotic fluid


Estimated Enrollment: 1651
Study Start Date: October 1999
Estimated Study Completion Date: April 2019
Estimated Primary Completion Date: April 2019 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Infertility patients
Patients undergoing infertility treatment at Massachusetts General Hospital Infertility Clinic.
Other: Completion questionnaires/providing biological samples
Participant completes baseline interview at enrollment, then completes online questionnaire on lifestyle and medical history. Diet questionnaire is completed at home and mailed back. Online questionnaire about personal care product use and medications is completed at each scheduled study visit.

Detailed Description:

Specific Aim #1: To determine the association of a mixture of paternal urinary concentrations of phthalate metabolites, BPA and parabens with the primary outcomes of implantation failure and live birth, and the secondary outcomes of chemical pregnancy (with no subsequent clinical pregnancy) and spontaneous abortion.

Hypothesis 1: Higher paternal urinary concentrations of a mixture of anti-androgenic phthalate metabolites of DEHP, DBP, DiBP, BBzP, and DiNP is associated with increased risk of implantation failure and reduced live birth rate, and increased risk of chemical pregnancy and spontaneous abortion.

Hypothesis 2: Higher paternal urinary concentrations of a mixture of estrogenic chemicals (BPA and parabens) is associated with increased risk of implantation failure and reduced live birth rate, and increased risk of chemical pregnancy and spontaneous abortion.

Specific Aim #2: To determine the association of a mixture of maternal urinary concentrations of phthalate metabolites, BPA and parabens with implantation failure and live birth rate, and the secondary outcomes of chemical pregnancy and spontaneous abortion.

Hypothesis 2: Higher maternal urinary concentrations of a mixture of anti-androgenic phthalate metabolites of DEHP, DBP, DiBP, BBzP, and DiNP is associated with increased risk of implantation failure and reduced live birth rate, and increased risk of chemical pregnancy and spontaneous abortion.

Hypothesis 3: Higher maternal urinary concentrations of a mixture of estrogenic BPA and parabens is associated with increased risk of implantation failure and reduced live birth rate, and increased risk of chemical pregnancy and spontaneous abortion.

Specific Aim #3: To determine the joint effect of maternal and paternal urinary concentrations of phthalate metabolites, BPA and parabens with primary outcomes of interest including implantation failure and live birth rate, and the secondary outcomes of chemical pregnancy and spontaneous abortion.

  Eligibility

Ages Eligible for Study:   18 Years to 51 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Study subjects will be recruited from couples seeking treatment of infertility at the MGH IVF Clinic. Men and women must be at least 18 years old to participate in the study.

Criteria

Couples undergoing treatment for infertility at MGH Clinic Men 18-55 years old Women 18 - 45 years old

  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: NCT00011713

Contacts
Contact: Russ Hauser, MD, ScD, MPH 617-432-3326 rhauser@hsph.harvard.edu
Contact: Patricia R Morey, MEd 617-432-7678 pmorey@hsph.harvard.edu

Locations
United States, Massachusetts
Harvard School of Public Health Recruiting
Boston, Massachusetts, United States, 02115
Contact: Russ B Hauser, MD, ScD    617-432-3326      
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Russ Hauser, MD, ScD, MPH Harvard School of Public Health
  More Information

Publications:

Responsible Party: Russ Hauser, Frederick Lee Hisaw Professor of Reproductive Physiology, National Institute of Environmental Health Sciences (NIEHS)
ClinicalTrials.gov Identifier: NCT00011713     History of Changes
Other Study ID Numbers: ES 009718, 2R01ES009718-16
Study First Received: February 27, 2001
Last Updated: October 3, 2014
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by National Institute of Environmental Health Sciences (NIEHS):
Semen
Infertility
ART - Assisted Reproduction Technology
Phthalates
Bisphenol A

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

ClinicalTrials.gov processed this record on November 27, 2014