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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00011713
Acronym
EARTH
Enrollment
1474
Registered
2001-03-01
Start date
1999-10-31
Completion date
2020-09-30
Last updated
2020-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility

Keywords

Semen, Infertility, ART - Assisted Reproduction Technology, Phthalates, Bisphenol A

Brief summary

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).

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.

Interventions

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.

Sponsors

Massachusetts General Hospital
CollaboratorOTHER
National Institute of Environmental Health Sciences (NIEHS)
Lead SponsorNIH

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Paternal Exposure to Environmental Chemicals2019To 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

MeasureTime frameDescription
Maternal Exposure to Environmental Chemicals2019To 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 15, 2026