An observational study in Infertility, sponsored by National Institute of Environmental Health Sciences (NIEHS). Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-09-11.
Sponsored by National Institute of Environmental Health Sciences (NIEHS) · Observational
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.
2,506 studies on the registry are indexed under Infertility; 407 are open to participants now.
This study's enrollment of 1,474 is above the median of 200 across 714 observational studies indexed under Infertility.
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Study subjects will be recruited from couples seeking treatment of infertility at the MGH IVF Clinic. Men and women must be at least 18 years old to participate in the study.
Exclusion Criteria:
Patients undergoing infertility treatment at Massachusetts General Hospital Infertility Clinic.
Other: Completion questionnaires/providing biological samples
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.
Paternal Exposure to Environmental Chemicals
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.
Time frame: 2019
Maternal Exposure to Environmental Chemicals
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.
Time frame: 2019
This study is completed, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.
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National Institute of Environmental Health Sciences (NIEHS)