Environment and Reproductive Health; Human Exposure to Bisphenol A, Phthalates and Fertility and Pregnancy Outcomes



Status:Recruiting
Conditions:Women's Studies, Infertility
Therapuetic Areas:Reproductive
Healthy:No
Age Range:18 - 55
Updated:2/20/2019
Start Date:October 1999
End Date:April 2019
Contact:Russ Hauser, MD, ScD, MPH
Email:rhauser@hsph.harvard.edu
Phone:617-432-3326

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Human Exposure to Bisphenol A, Phthalates and Fertility, Pregnancy Outcomes.

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).

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.

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.
We found this trial at
1
site
25 Shattuck Street
Boston, Massachusetts 02115
Phone: 617-432-3326
?
mi
from
Boston, MA
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