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

Completed

• Conditions: Infertility
• Interventions: Other: Completion questionnaires/providing biological samples

• Registration Number: NCT00011713
• Lead Sponsor: National Institute of Environmental Health Sciences (NIEHS)

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.

Study Timeline

• Study Start: 1999-10
• Study First Submitted: 2001-02-27
• Study First Submitted QC: 2001-02-28
• Study First Posted: 2001-03-01
• Status Verified: 2020-09
• Primary Completion: 2020-09
• Study Completion: 2020-09
• Last Update Submitted: 2020-09-09
• Last Update Posted: 2020-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1474

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Infertility patients	Completion questionnaires/providing biological samples	Patients undergoing infertility treatment at Massachusetts General Hospital Infertility Clinic.

Primary Outcome Measures

Name	Time	Method
Paternal Exposure to Environmental Chemicals	2019	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.

Secondary Outcome Measures

Name	Time	Method
Maternal Exposure to Environmental Chemicals	2019	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.

Trial Locations

Locations (1)

Harvard School of Public Health; 🇺🇸 Boston, Massachusetts, United States