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

NCT ID: NCT00011713

Last Updated: 2020-09-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1474 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 1999-10-31
• Study Completion Date: 2020-09-30

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.

Conditions

Infertility

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Infertility patients

Patients undergoing infertility treatment at Massachusetts General Hospital Infertility Clinic.

Completion questionnaires/providing biological samples

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: collaborator

National Institute of Environmental Health Sciences (NIEHS)

NIH

Sponsor Role: lead

Responsible Party

Russ Hauser

Frederick Lee Hisaw Professor of Reproductive Physiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Russ Hauser, MD, ScD, MPH

Role: PRINCIPAL_INVESTIGATOR

Harvard School of Public Health (HSPH)

Locations

Harvard School of Public Health

Boston, Massachusetts, United States

Countries

United States

References

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Minguez-Alarcon L, Souter I, Chiu YH, Williams PL, Ford JB, Ye X, Calafat AM, Hauser R; Earth Study Team. Urinary concentrations of cyclohexane-1,2-dicarboxylic acid monohydroxy isononyl ester, a metabolite of the non-phthalate plasticizer di(isononyl)cyclohexane-1,2-dicarboxylate (DINCH), and markers of ovarian response among women attending a fertility center. Environ Res. 2016 Nov;151:595-600. doi: 10.1016/j.envres.2016.08.012. Epub 2016 Sep 2.

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Messerlian C, Wylie BJ, Minguez-Alarcon L, Williams PL, Ford JB, Souter IC, Calafat AM, Hauser R; Earth Study Team. Urinary Concentrations of Phthalate Metabolites and Pregnancy Loss Among Women Conceiving with Medically Assisted Reproduction. Epidemiology. 2016 Nov;27(6):879-88. doi: 10.1097/EDE.0000000000000525.

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Gaskins AJ, Williams PL, Keller MG, Souter I, Hauser R, Chavarro JE; EARTH Study Team. Maternal physical and sedentary activities in relation to reproductive outcomes following IVF. Reprod Biomed Online. 2016 Oct;33(4):513-521. doi: 10.1016/j.rbmo.2016.07.002. Epub 2016 Jul 20.

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Minguez-Alarcon L, Gaskins AJ, Chiu YH, Souter I, Williams PL, Calafat AM, Hauser R, Chavarro JE; EARTH Study team. Dietary folate intake and modification of the association of urinary bisphenol A concentrations with in vitro fertilization outcomes among women from a fertility clinic. Reprod Toxicol. 2016 Oct;65:104-112. doi: 10.1016/j.reprotox.2016.07.012. Epub 2016 Jul 14.

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Abadia L, Gaskins AJ, Chiu YH, Williams PL, Keller M, Wright DL, Souter I, Hauser R, Chavarro JE; Environment and Reproductive Health Study Team. Serum 25-hydroxyvitamin D concentrations and treatment outcomes of women undergoing assisted reproduction. Am J Clin Nutr. 2016 Sep;104(3):729-35. doi: 10.3945/ajcn.115.126359. Epub 2016 Jul 27.

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Hu Y, Chiu YH, Hauser R, Chavarro J, Sun Q. Overall and class-specific scores of pesticide residues from fruits and vegetables as a tool to rank intake of pesticide residues in United States: A validation study. Environ Int. 2016 Jul-Aug;92-93:294-300. doi: 10.1016/j.envint.2016.04.028. Epub 2016 Apr 26.

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Gaskins AJ, Chiu YH, Williams PL, Keller MG, Toth TL, Hauser R, Chavarro JE; EARTH Study Team. Maternal whole grain intake and outcomes of in vitro fertilization. Fertil Steril. 2016 Jun;105(6):1503-1510.e4. doi: 10.1016/j.fertnstert.2016.02.015. Epub 2016 Feb 28.

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Hauser R, Gaskins AJ, Souter I, Smith KW, Dodge LE, Ehrlich S, Meeker JD, Calafat AM, Williams PL; EARTH Study Team. Urinary Phthalate Metabolite Concentrations and Reproductive Outcomes among Women Undergoing in Vitro Fertilization: Results from the EARTH Study. Environ Health Perspect. 2016 Jun;124(6):831-9. doi: 10.1289/ehp.1509760. Epub 2015 Nov 6.

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Xia W, Chiu YH, Afeiche MC, Williams PL, Ford JB, Tanrikut C, Souter I, Hauser R, Chavarro JE; EARTH study team. Impact of men's dairy intake on assisted reproductive technology outcomes among couples attending a fertility clinic. Andrology. 2016 Mar;4(2):277-83. doi: 10.1111/andr.12151. Epub 2016 Jan 29.

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Chavarro JE, Minguez-Alarcon L, Chiu YH, Gaskins AJ, Souter I, Williams PL, Calafat AM, Hauser R; EARTH Study Team. Soy Intake Modifies the Relation Between Urinary Bisphenol A Concentrations and Pregnancy Outcomes Among Women Undergoing Assisted Reproduction. J Clin Endocrinol Metab. 2016 Mar;101(3):1082-90. doi: 10.1210/jc.2015-3473. Epub 2016 Jan 27.

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Afeiche MC, Chiu YH, Gaskins AJ, Williams PL, Souter I, Wright DL, Hauser R, Chavarro JE; EARTH Study team. Dairy intake in relation to in vitro fertilization outcomes among women from a fertility clinic. Hum Reprod. 2016 Mar;31(3):563-71. doi: 10.1093/humrep/dev344. Epub 2016 Jan 18.

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Minguez-Alarcon L, Chiu YH, Messerlian C, Williams PL, Sabatini ME, Toth TL, Ford JB, Calafat AM, Hauser R; EARTH Study Team. Urinary paraben concentrations and in vitro fertilization outcomes among women from a fertility clinic. Fertil Steril. 2016 Mar;105(3):714-721. doi: 10.1016/j.fertnstert.2015.11.021. Epub 2015 Dec 2.

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Lewis RC, Hauser R, Wang L, Kavet R, Meeker JD. Personal power-frequency magnetic field exposure in women recruited at an infertility clinic: association with physical activity and temporal variability. Radiat Prot Dosimetry. 2016 Mar;168(4):478-88. doi: 10.1093/rpd/ncv365. Epub 2015 Jul 7.

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PMID: 26152565 (View on PubMed)

Messerlian C, Souter I, Gaskins AJ, Williams PL, Ford JB, Chiu YH, Calafat AM, Hauser R; Earth Study Team. Urinary phthalate metabolites and ovarian reserve among women seeking infertility care. Hum Reprod. 2016 Jan;31(1):75-83. doi: 10.1093/humrep/dev292. Epub 2015 Nov 15.

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PMID: 26573529 (View on PubMed)

Braun JM, Gennings C, Hauser R, Webster TF. What Can Epidemiological Studies Tell Us about the Impact of Chemical Mixtures on Human Health? Environ Health Perspect. 2016 Jan;124(1):A6-9. doi: 10.1289/ehp.1510569.

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PMID: 26720830 (View on PubMed)

Lewis RC, Hauser R, Maynard AD, Neitzel RL, Wang L, Kavet R, Meeker JD. Exposure to Power-Frequency Magnetic Fields and the Risk of Infertility and Adverse Pregnancy Outcomes: Update on the Human Evidence and Recommendations for Future Study Designs. J Toxicol Environ Health B Crit Rev. 2016;19(1):29-45. doi: 10.1080/10937404.2015.1134370.

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PMID: 27030583 (View on PubMed)

Dodge LE, Williams PL, Williams MA, Missmer SA, Souter I, Calafat AM, Hauser R; EARTH Study Team. Associations between paternal urinary phthalate metabolite concentrations and reproductive outcomes among couples seeking fertility treatment. Reprod Toxicol. 2015 Dec;58:184-93. doi: 10.1016/j.reprotox.2015.09.007. Epub 2015 Oct 9.

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PMID: 26456810 (View on PubMed)

Styer AK, Gaskins AJ, Brady PC, Sluss PM, Chavarro JE, Hauser RB, Toth TL. Dynamic antimullerian hormone levels during controlled ovarian hyperstimulation predict in vitro fertilization response and pregnancy outcomes. Fertil Steril. 2015 Nov;104(5):1153-61.e1-7. doi: 10.1016/j.fertnstert.2015.07.1161. Epub 2015 Aug 24.

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PMID: 26315051 (View on PubMed)

Gaskins AJ, Chiu YH, Williams PL, Ford JB, Toth TL, Hauser R, Chavarro JE; EARTH Study Team. Association between serum folate and vitamin B-12 and outcomes of assisted reproductive technologies. Am J Clin Nutr. 2015 Oct;102(4):943-50. doi: 10.3945/ajcn.115.112185. Epub 2015 Sep 9.

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PMID: 26354529 (View on PubMed)

Xia W, Chiu YH, Williams PL, Gaskins AJ, Toth TL, Tanrikut C, Hauser R, Chavarro JE. Men's meat intake and treatment outcomes among couples undergoing assisted reproduction. Fertil Steril. 2015 Oct;104(4):972-979. doi: 10.1016/j.fertnstert.2015.06.037. Epub 2015 Jul 20.

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PMID: 26206344 (View on PubMed)

Minguez-Alarcon L, Gaskins AJ, Chiu YH, Williams PL, Ehrlich S, Chavarro JE, Petrozza JC, Ford JB, Calafat AM, Hauser R; EARTH Study Team. Urinary bisphenol A concentrations and association with in vitro fertilization outcomes among women from a fertility clinic. Hum Reprod. 2015 Sep;30(9):2120-8. doi: 10.1093/humrep/dev183. Epub 2015 Jul 24.

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PMID: 26209788 (View on PubMed)

Minguez-Alarcon L, Afeiche MC, Chiu YH, Vanegas JC, Williams PL, Tanrikut C, Toth TL, Hauser R, Chavarro JE. Male soy food intake was not associated with in vitro fertilization outcomes among couples attending a fertility center. Andrology. 2015 Jul;3(4):702-8. doi: 10.1111/andr.12046. Epub 2015 Jun 20.

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PMID: 26097060 (View on PubMed)

Dodge LE, Williams PL, Williams MA, Missmer SA, Toth TL, Calafat AM, Hauser R. Paternal Urinary Concentrations of Parabens and Other Phenols in Relation to Reproductive Outcomes among Couples from a Fertility Clinic. Environ Health Perspect. 2015 Jul;123(7):665-71. doi: 10.1289/ehp.1408605. Epub 2015 Mar 13.

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PMID: 25767892 (View on PubMed)

Chiu YH, Afeiche MC, Gaskins AJ, Williams PL, Petrozza JC, Tanrikut C, Hauser R, Chavarro JE. Fruit and vegetable intake and their pesticide residues in relation to semen quality among men from a fertility clinic. Hum Reprod. 2015 Jun;30(6):1342-51. doi: 10.1093/humrep/dev064. Epub 2015 Mar 30.

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PMID: 25824023 (View on PubMed)

Dodge LE, Kelley KE, Williams PL, Williams MA, Hernandez-Diaz S, Missmer SA, Hauser R. Medications as a source of paraben exposure. Reprod Toxicol. 2015 Apr;52:93-100. doi: 10.1016/j.reprotox.2015.02.002. Epub 2015 Feb 26.

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PMID: 25728410 (View on PubMed)

Vanegas JC, Afeiche MC, Gaskins AJ, Minguez-Alarcon L, Williams PL, Wright DL, Toth TL, Hauser R, Chavarro JE. Soy food intake and treatment outcomes of women undergoing assisted reproductive technology. Fertil Steril. 2015 Mar;103(3):749-55.e2. doi: 10.1016/j.fertnstert.2014.12.104. Epub 2015 Jan 7.

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PMID: 25577465 (View on PubMed)

Wright DL, Afeiche MC, Ehrlich S, Smith K, Williams PL, Chavarro JE, Batsis M, Toth TL, Hauser R. Hair mercury concentrations and in vitro fertilization (IVF) outcomes among women from a fertility clinic. Reprod Toxicol. 2015 Jan;51:125-132. doi: 10.1016/j.reprotox.2015.01.003. Epub 2015 Jan 17.

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PMID: 25601638 (View on PubMed)

Gaskins AJ, Rich-Edwards JW, Hauser R, Williams PL, Gillman MW, Penzias A, Missmer SA, Chavarro JE. Prepregnancy dietary patterns and risk of pregnancy loss. Am J Clin Nutr. 2014 Oct;100(4):1166-72. doi: 10.3945/ajcn.114.083634. Epub 2014 Aug 13.

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PMID: 25240079 (View on PubMed)

Peretz J, Vrooman L, Ricke WA, Hunt PA, Ehrlich S, Hauser R, Padmanabhan V, Taylor HS, Swan SH, VandeVoort CA, Flaws JA. Bisphenol a and reproductive health: update of experimental and human evidence, 2007-2013. Environ Health Perspect. 2014 Aug;122(8):775-86. doi: 10.1289/ehp.1307728. Epub 2014 Jun 4.

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PMID: 24896072 (View on PubMed)

Gaskins AJ, Rich-Edwards JW, Hauser R, Williams PL, Gillman MW, Ginsburg ES, Missmer SA, Chavarro JE. Maternal prepregnancy folate intake and risk of spontaneous abortion and stillbirth. Obstet Gynecol. 2014 Jul;124(1):23-31. doi: 10.1097/AOG.0000000000000343.

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PMID: 24901281 (View on PubMed)

Meeker JD, Cooper EM, Stapleton HM, Hauser R. Exploratory analysis of urinary metabolites of phosphorus-containing flame retardants in relation to markers of male reproductive health. Endocr Disruptors (Austin). 2013 Oct 1;1(1):e26306. doi: 10.4161/endo.26306.

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PMID: 24795899 (View on PubMed)

Meeker JD, Cooper EM, Stapleton HM, Hauser R. Urinary metabolites of organophosphate flame retardants: temporal variability and correlations with house dust concentrations. Environ Health Perspect. 2013 May;121(5):580-5. doi: 10.1289/ehp.1205907. Epub 2013 Mar 5.

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PMID: 23461877 (View on PubMed)

Braun JM, Sathyanarayana S, Hauser R. Phthalate exposure and children's health. Curr Opin Pediatr. 2013 Apr;25(2):247-54. doi: 10.1097/MOP.0b013e32835e1eb6.

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PMID: 23429708 (View on PubMed)

Johnson PI, Stapleton HM, Mukherjee B, Hauser R, Meeker JD. Associations between brominated flame retardants in house dust and hormone levels in men. Sci Total Environ. 2013 Feb 15;445-446:177-84. doi: 10.1016/j.scitotenv.2012.12.017. Epub 2013 Jan 16.

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PMID: 23333513 (View on PubMed)

McAuliffe ME, Williams PL, Korrick SA, Dadd R, Perry MJ. The association between sperm sex chromosome disomy and semen concentration, motility and morphology. Hum Reprod. 2012 Oct;27(10):2918-26. doi: 10.1093/humrep/des302. Epub 2012 Aug 14.

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PMID: 22892419 (View on PubMed)

Mendiola J, Meeker JD, Jorgensen N, Andersson AM, Liu F, Calafat AM, Redmon JB, Drobnis EZ, Sparks AE, Wang C, Hauser R, Swan SH. Urinary concentrations of di(2-ethylhexyl) phthalate metabolites and serum reproductive hormones: pooled analysis of fertile and infertile men. J Androl. 2012 May-Jun;33(3):488-98. doi: 10.2164/jandrol.111.013557. Epub 2011 May 19.

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PMID: 21597090 (View on PubMed)

McAuliffe ME, Williams PL, Korrick SA, Altshul LM, Perry MJ. Environmental exposure to polychlorinated biphenyls and p,p'-DDE and sperm sex-chromosome disomy. Environ Health Perspect. 2012 Apr;120(4):535-40. doi: 10.1289/ehp.1104017. Epub 2011 Dec 21.

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PMID: 22189045 (View on PubMed)

Perry MJ, Chen X, McAuliffe ME, Maity A, Deloid GM. Semi-automated scoring of triple-probe FISH in human sperm: methods and further validation. Cytometry A. 2011 Aug;79(8):661-6. doi: 10.1002/cyto.a.21078. Epub 2011 May 12.

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PMID: 21567938 (View on PubMed)

Meeker JD, Yang T, Ye X, Calafat AM, Hauser R. Urinary concentrations of parabens and serum hormone levels, semen quality parameters, and sperm DNA damage. Environ Health Perspect. 2011 Feb;119(2):252-7. doi: 10.1289/ehp.1002238. Epub 2010 Sep 28.

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PMID: 20876036 (View on PubMed)

Johnson PI, Stapleton HM, Sjodin A, Meeker JD. Relationships between polybrominated diphenyl ether concentrations in house dust and serum. Environ Sci Technol. 2010 Jul 15;44(14):5627-32. doi: 10.1021/es100697q.

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PMID: 20521814 (View on PubMed)

Meeker JD, Stapleton HM. House dust concentrations of organophosphate flame retardants in relation to hormone levels and semen quality parameters. Environ Health Perspect. 2010 Mar;118(3):318-23. doi: 10.1289/ehp.0901332.

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PMID: 20194068 (View on PubMed)

Meeker JD, Johnson PI, Camann D, Hauser R. Polybrominated diphenyl ether (PBDE) concentrations in house dust are related to hormone levels in men. Sci Total Environ. 2009 May 1;407(10):3425-9. doi: 10.1016/j.scitotenv.2009.01.030. Epub 2009 Feb 10.

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PMID: 19211133 (View on PubMed)

Meeker JD, Calafat AM, Hauser R. Urinary metabolites of di(2-ethylhexyl) phthalate are associated with decreased steroid hormone levels in adult men. J Androl. 2009 May-Jun;30(3):287-97. doi: 10.2164/jandrol.108.006403. Epub 2008 Dec 4.

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PMID: 19059903 (View on PubMed)

Meeker JD, Barr DB, Hauser R. Pyrethroid insecticide metabolites are associated with serum hormone levels in adult men. Reprod Toxicol. 2009 Apr;27(2):155-60. doi: 10.1016/j.reprotox.2008.12.012. Epub 2009 Jan 24.

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PMID: 19429394 (View on PubMed)

Mahalingaiah S, Meeker JD, Pearson KR, Calafat AM, Ye X, Petrozza J, Hauser R. Temporal variability and predictors of urinary bisphenol A concentrations in men and women. Environ Health Perspect. 2008 Feb;116(2):173-8. doi: 10.1289/ehp.10605.

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PMID: 18288314 (View on PubMed)

Meeker JD, Ravi SR, Barr DB, Hauser R. Circulating estradiol in men is inversely related to urinary metabolites of nonpersistent insecticides. Reprod Toxicol. 2008 Feb;25(2):184-91. doi: 10.1016/j.reprotox.2007.12.005. Epub 2007 Dec 28.

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PMID: 18249523 (View on PubMed)

Meeker JD, Calafat AM, Hauser R. Di(2-ethylhexyl) phthalate metabolites may alter thyroid hormone levels in men. Environ Health Perspect. 2007 Jul;115(7):1029-34. doi: 10.1289/ehp.9852.

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PMID: 17637918 (View on PubMed)

Meeker JD, Altshul L, Hauser R. Serum PCBs, p,p'-DDE and HCB predict thyroid hormone levels in men. Environ Res. 2007 Jun;104(2):296-304. doi: 10.1016/j.envres.2006.11.007. Epub 2006 Dec 26.

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PMID: 17189629 (View on PubMed)

Duty SM, Ackerman RM, Calafat AM, Hauser R. Personal care product use predicts urinary concentrations of some phthalate monoesters. Environ Health Perspect. 2005 Nov;113(11):1530-5. doi: 10.1289/ehp.8083.

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PMID: 16263507 (View on PubMed)

Chen Z, Godfrey-Bailey L, Schiff I, Hauser R. Impact of seasonal variation, age and smoking status on human semen parameters: The Massachusetts General Hospital experience. J Exp Clin Assist Reprod. 2004 Sep 30;1(1):2. doi: 10.1186/1743-1050-1-2.

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PMID: 15507127 (View on PubMed)

Kadir M, Hood RB, Minguez-Alarcon L, Maldonado-Carceles AB, Ford JB, Souter I, Chavarro JE, Gaskins AJ; EARTH Study Team. Folate intake and ovarian reserve among women attending a fertility center. Fertil Steril. 2022 Jan;117(1):171-180. doi: 10.1016/j.fertnstert.2021.09.037. Epub 2021 Nov 19.

Reference Type: DERIVED

PMID: 34809974 (View on PubMed)

Nassan FL, Chiu YH, Vanegas JC, Gaskins AJ, Williams PL, Ford JB, Attaman J, Hauser R, Chavarro JE; EARTH Study Team. Intake of protein-rich foods in relation to outcomes of infertility treatment with assisted reproductive technologies. Am J Clin Nutr. 2018 Nov 1;108(5):1104-1112. doi: 10.1093/ajcn/nqy185.

Reference Type: DERIVED

PMID: 30475972 (View on PubMed)

Other Identifiers

2R01ES009718-16

Identifier Type: NIH

Identifier Source: secondary_id

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ES 009718

Identifier Type: -

Identifier Source: org_study_id