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

National Institutes of Health (NIH)

Status: Completed

Conditions: Infertility

Treatments: Other: Completion questionnaires/providing biological samples

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT00011713

ES 009718

2R01ES009718-16 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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).

Full 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.

Enrollment: 1,474 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

1,474 participants in 1 patient group

Infertility patients

Description:

Patients undergoing infertility treatment at Massachusetts General Hospital Infertility Clinic.

Treatment:

Other: Completion questionnaires/providing biological samples