Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00011713
Status:
COMPLETED
Last Update Posted:
2020-09-11
First Post:
2001-02-27
Brief Title:
Environment and Reproductive Health Human Exposure to Bisphenol A Phthalates and Fertility and Pregnancy Outcomes
Sponsor:
National Institute of Environmental Health Sciences NIEHS
Organization:
National Institute of Environmental Health Sciences NIEHS
Study Overview
Official Title:
Human Exposure to Bisphenol A Phthalates and Fertility Pregnancy Outcomes
Status:
COMPLETED
Status Verified Date:
2020-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EARTH
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 andor 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2R01ES009718-16 | NIH | None | httpsreporternihgovquickSearch2R01ES009718-16 |