InfertilityEARTHNCT00011713
Environment and Reproductive Health; Human Exposure to Bisphenol A, Phthalates and Fertility and Pregnancy Outcomes
An observational study of Infertility, run by National Institute of Environmental Health Sciences (NIEHS) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Infertility
- What is being tested?
- Completion questionnaires/providing biological samples
- How many people
- 1,474 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 1999to Sep 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: 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.
Who may be able to join
- Couples undergoing treatment for infertility at MGH Clinic
- Men 18-55 years old
- Women 18 - 45 years old
Who cannot join
- 1. Any individual or couple who is not undergoing infertility treatment at MGH Clinic and or who is outside of age range.
Trial locations and contacts
1 site in 1 country.
United States1 site
Harvard School of Public Health
Boston, Massachusetts, 02115
About this study
Official title: Human Exposure to Bisphenol A, Phthalates and Fertility, Pregnancy Outcomes.
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).
Read the 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.
- Conditions
- Infertility
- Being tested
- Completion questionnaires/providing biological samples
- Keywords
- Semen, Infertility, ART - Assisted Reproduction Technology, Phthalates, Bisphenol A
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Completion questionnaires/providing biological samplesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Infertility patients | Patients undergoing infertility treatment at Massachusetts General Hospital Infertility Clinic. Receives: Other: Completion questionnaires/providing biological samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2019
Secondary outcomes (1)
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.
Measured: 2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2001 (estimated)
- Study startOct 1999
- Primary completionSep 2020
- Study completionSep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (100)Papers the sponsor has linked to this study.
- Other trials for InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,474 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Environmental Health Sciences (NIEHS)
- Sponsor type
- US National Institutes of Health
- Collaborators
- Massachusetts General Hospital
- Responsible party
- Principal investigator, Russ Hauser, National Institute of Environmental Health Sciences (NIEHS)
- Investigators
- Russ Hauser, MD, ScD, MPH, Principal investigator, Harvard School of Public Health (HSPH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00011713
- Sponsor's protocol ID
- ES 009718
- Other IDs
- 2R01ES009718-16
- Acronym
- EARTH
- Status last verified
- Sep 2020
- First submitted
- 27 Feb 2001
- Last updated
- 11 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Meeker JD, Singh NP, Hauser R. Serum concentrations of estradiol and free T4 are inversely correlated with sperm DNA damage in men from an infertility clinic. J Androl. 2008 Jul-Aug;29(4):379-88. doi: 10.2164/jandrol.107.004416. Epub 2008 Mar 20.
PubMed 18359755Chavarro JE, Toth TL, Sadio SM, Hauser R. Soy food and isoflavone intake in relation to semen quality parameters among men from an infertility clinic. Hum Reprod. 2008 Nov;23(11):2584-90. doi: 10.1093/humrep/den243. Epub 2008 Jul 23.
PubMed 18650557Chavarro JE, Toth TL, Wright DL, Meeker JD, Hauser R. Body mass index in relation to semen quality, sperm DNA integrity, and serum reproductive hormone levels among men attending an infertility clinic. Fertil Steril. 2010 May 1;93(7):2222-31. doi: 10.1016/j.fertnstert.2009.01.100. Epub 2009 Mar 3.
PubMed 19261274Meeker JD, Missmer SA, Altshul L, Vitonis AF, Ryan L, Cramer DW, Hauser R. Serum and follicular fluid organochlorine concentrations among women undergoing assisted reproduction technologies. Environ Health. 2009 Jul 14;8:32. doi: 10.1186/1476-069X-8-32.
PubMed 19594949Mok-Lin E, Ehrlich S, Williams PL, Petrozza J, Wright DL, Calafat AM, Ye X, Hauser R. Urinary bisphenol A concentrations and ovarian response among women undergoing IVF. Int J Androl. 2010 Apr;33(2):385-93. doi: 10.1111/j.1365-2605.2009.01014.x. Epub 2009 Nov 30.
PubMed 20002217Meeker JD, Calafat AM, Hauser R. Urinary bisphenol A concentrations in relation to serum thyroid and reproductive hormone levels in men from an infertility clinic. Environ Sci Technol. 2010 Feb 15;44(4):1458-63. doi: 10.1021/es9028292.
PubMed 20030380Meeker JD, Ehrlich S, Toth TL, Wright DL, Calafat AM, Trisini AT, Ye X, Hauser R. Semen quality and sperm DNA damage in relation to urinary bisphenol A among men from an infertility clinic. Reprod Toxicol. 2010 Dec;30(4):532-9. doi: 10.1016/j.reprotox.2010.07.005. Epub 2010 Jul 23.
PubMed 20656017Chavarro JE, Furtado J, Toth TL, Ford J, Keller M, Campos H, Hauser R. Trans-fatty acid levels in sperm are associated with sperm concentration among men from an infertility clinic. Fertil Steril. 2011 Apr;95(5):1794-7. doi: 10.1016/j.fertnstert.2010.10.039. Epub 2010 Nov 11.
PubMed 21071027Braun JM, Smith KW, Williams PL, Calafat AM, Berry K, Ehrlich S, Hauser R. Variability of urinary phthalate metabolite and bisphenol A concentrations before and during pregnancy. Environ Health Perspect. 2012 May;120(5):739-45. doi: 10.1289/ehp.1104139. Epub 2012 Jan 19.
PubMed 22262702Attaman JA, Toth TL, Furtado J, Campos H, Hauser R, Chavarro JE. Dietary fat and semen quality among men attending a fertility clinic. Hum Reprod. 2012 May;27(5):1466-74. doi: 10.1093/humrep/des065. Epub 2012 Mar 13.
PubMed 22416013Ehrlich S, Williams PL, Missmer SA, Flaws JA, Berry KF, Calafat AM, Ye X, Petrozza JC, Wright D, Hauser R. Urinary bisphenol A concentrations and implantation failure among women undergoing in vitro fertilization. Environ Health Perspect. 2012 Jul;120(7):978-83. doi: 10.1289/ehp.1104307. Epub 2012 Apr 6.
PubMed 22484414Chavarro JE, Ehrlich S, Colaci DS, Wright DL, Toth TL, Petrozza JC, Hauser R. Body mass index and short-term weight change in relation to treatment outcomes in women undergoing assisted reproduction. Fertil Steril. 2012 Jul;98(1):109-16. doi: 10.1016/j.fertnstert.2012.04.012. Epub 2012 May 16.
PubMed 22607889Ferguson KK, Hauser R, Altshul L, Meeker JD. Serum concentrations of p, p'-DDE, HCB, PCBs and reproductive hormones among men of reproductive age. Reprod Toxicol. 2012 Nov;34(3):429-35. doi: 10.1016/j.reprotox.2012.04.006. Epub 2012 May 5.
PubMed 22564984Meeker JD, Calafat AM, Hauser R. Urinary phthalate metabolites and their biotransformation products: predictors and temporal variability among men and women. J Expo Sci Environ Epidemiol. 2012 Jul;22(4):376-85. doi: 10.1038/jes.2012.7. Epub 2012 Feb 22.
PubMed 22354176Smith KW, Braun JM, Williams PL, Ehrlich S, Correia KF, Calafat AM, Ye X, Ford J, Keller M, Meeker JD, Hauser R. Predictors and variability of urinary paraben concentrations in men and women, including before and during pregnancy. Environ Health Perspect. 2012 Nov;120(11):1538-43. doi: 10.1289/ehp.1104614. Epub 2012 Jun 21.
PubMed 22721761
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Human Exposure to Bisphenol A, Phthalates and Fertility, Pregnancy Outcomes.
- ClinicalTrials.gov ID
- NCT00011713
- Acronym / sponsor ID
- EARTH / ES 009718
- Conditions
- Infertility
- Keywords
- Semen, Infertility, ART - Assisted Reproduction Technology, Phthalates, Bisphenol A
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,474 participants (actual)
- Lead sponsor
- National Institute of Environmental Health Sciences (NIEHS)US National Institutes of Health
- Collaborators
- Massachusetts General Hospital
- Study start
- Oct 1999 (actual)
- Primary completion
- Sep 2020 (actual)
- Study completion
- Sep 2020 (actual)
- First posted
- 1 Mar 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Infertility patients | – | Other: Completion questionnaires/providing biological samplesPatients undergoing infertility treatment at Massachusetts General Hospital Infertility Clinic. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 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.
Key inclusion criteria (3 listed)
- Couples undergoing treatment for infertility at MGH Clinic
- Men 18-55 years old
- Women 18 - 45 years old
Key exclusion criteria (1 listed)
- 1. Any individual or couple who is not undergoing infertility treatment at MGH Clinic and or who is outside of age range.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Completion questionnaires/providing biological samplesParticipant 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. | Other | Infertility patients |
Primary outcome
Paternal Exposure to Environmental Chemicals
Time frame: 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.
1 secondary outcome
Maternal Exposure to Environmental Chemicals
Time frame: 2019
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2020.
- Results publication: PubMed 18359755Meeker JD, Singh NP, Hauser R. Serum concentrations of estradiol and free T4 are inversely correlated with sperm DNA damage in men from an infertility clinic. J Androl. 2008 Jul-Aug;29(4):379-88. doi: 10.2164/jandrol.107.004416. Epub 2008 Mar 20.
- Results publication: PubMed 18650557Chavarro JE, Toth TL, Sadio SM, Hauser R. Soy food and isoflavone intake in relation to semen quality parameters among men from an infertility clinic. Hum Reprod. 2008 Nov;23(11):2584-90. doi: 10.1093/humrep/den243. Epub 2008 Jul 23.
- Results publication: PubMed 19261274Chavarro JE, Toth TL, Wright DL, Meeker JD, Hauser R. Body mass index in relation to semen quality, sperm DNA integrity, and serum reproductive hormone levels among men attending an infertility clinic. Fertil Steril. 2010 May 1;93(7):2222-31. doi: 10.1016/j.fertnstert.2009.01.100. Epub 2009 Mar 3.
- Results publication: PubMed 19594949Meeker JD, Missmer SA, Altshul L, Vitonis AF, Ryan L, Cramer DW, Hauser R. Serum and follicular fluid organochlorine concentrations among women undergoing assisted reproduction technologies. Environ Health. 2009 Jul 14;8:32. doi: 10.1186/1476-069X-8-32.
- Results publication: PubMed 20002217Mok-Lin E, Ehrlich S, Williams PL, Petrozza J, Wright DL, Calafat AM, Ye X, Hauser R. Urinary bisphenol A concentrations and ovarian response among women undergoing IVF. Int J Androl. 2010 Apr;33(2):385-93. doi: 10.1111/j.1365-2605.2009.01014.x. Epub 2009 Nov 30.
- Results publication: PubMed 20030380Meeker JD, Calafat AM, Hauser R. Urinary bisphenol A concentrations in relation to serum thyroid and reproductive hormone levels in men from an infertility clinic. Environ Sci Technol. 2010 Feb 15;44(4):1458-63. doi: 10.1021/es9028292.
- Results publication: PubMed 20656017Meeker JD, Ehrlich S, Toth TL, Wright DL, Calafat AM, Trisini AT, Ye X, Hauser R. Semen quality and sperm DNA damage in relation to urinary bisphenol A among men from an infertility clinic. Reprod Toxicol. 2010 Dec;30(4):532-9. doi: 10.1016/j.reprotox.2010.07.005. Epub 2010 Jul 23.
- Results publication: PubMed 21071027Chavarro JE, Furtado J, Toth TL, Ford J, Keller M, Campos H, Hauser R. Trans-fatty acid levels in sperm are associated with sperm concentration among men from an infertility clinic. Fertil Steril. 2011 Apr;95(5):1794-7. doi: 10.1016/j.fertnstert.2010.10.039. Epub 2010 Nov 11.
- Results publication: PubMed 22262702Braun JM, Smith KW, Williams PL, Calafat AM, Berry K, Ehrlich S, Hauser R. Variability of urinary phthalate metabolite and bisphenol A concentrations before and during pregnancy. Environ Health Perspect. 2012 May;120(5):739-45. doi: 10.1289/ehp.1104139. Epub 2012 Jan 19.
- Results publication: PubMed 22416013Attaman JA, Toth TL, Furtado J, Campos H, Hauser R, Chavarro JE. Dietary fat and semen quality among men attending a fertility clinic. Hum Reprod. 2012 May;27(5):1466-74. doi: 10.1093/humrep/des065. Epub 2012 Mar 13.
- Results publication: PubMed 22484414Ehrlich S, Williams PL, Missmer SA, Flaws JA, Berry KF, Calafat AM, Ye X, Petrozza JC, Wright D, Hauser R. Urinary bisphenol A concentrations and implantation failure among women undergoing in vitro fertilization. Environ Health Perspect. 2012 Jul;120(7):978-83. doi: 10.1289/ehp.1104307. Epub 2012 Apr 6.
- Results publication: PubMed 22607889Chavarro JE, Ehrlich S, Colaci DS, Wright DL, Toth TL, Petrozza JC, Hauser R. Body mass index and short-term weight change in relation to treatment outcomes in women undergoing assisted reproduction. Fertil Steril. 2012 Jul;98(1):109-16. doi: 10.1016/j.fertnstert.2012.04.012. Epub 2012 May 16.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Russ Hauser, MD, ScD, MPH principal investigator
Harvard School of Public Health (HSPH)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility, run by National Institute of Environmental Health Sciences (NIEHS) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Paternal Exposure to Environmental Chemicals (time frame: 2019). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00011713, which also lists 100 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2020.