Boston, Massachusetts 02115


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).


Study summary:

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.


Criteria:

Inclusion Criteria: 1. Couples undergoing treatment for infertility at MGH Clinic 2. Men 18-55 years old 3. Women 18 - 45 years old Exclusion Criteria: 1. Any individual or couple who is not undergoing infertility treatment at MGH Clinic and or who is outside of age range.


NCT ID:

NCT00011713


Primary Contact:

Principal Investigator
Russ Hauser, MD, ScD, MPH
Harvard School of Public Health

Russ Hauser, MD, ScD, MPH
Phone: 617-432-3326
Email: rhauser@hsph.harvard.edu


Backup Contact:

Email: pmorey@hsph.harvard.edu
Patricia R Morey, MEd
Phone: 617-432-7678


Location Contact:

Boston, Massachusetts 02115
United States

Russ B Hauser, MD, ScD
Phone: 617-432-3326

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: December 15, 2017

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