Infertility Clinical Trial
Official title:
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.
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