Endocrine Disrupting Chemicals: Potential Effects on Male and Female Reproductive Health in Saskatchewan
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ClinicalTrials.gov Identifier: NCT02272439 |
Recruitment Status :
Completed
First Posted : October 23, 2014
Last Update Posted : December 21, 2015
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The overall objective of this study is to determine whether serum BPA and/or phthalate concentrations differ in fertile versus infertile men and women in Saskatchewan. The investigators will test the following hypothesis:
- Serum BPA and/or phthalate concentrations will be greater in women with unexplained infertility or PCOS compared to a control group
- Serum BPA and/or phthalate concentrations will be greater in men with male factor infertility compared to a control group
Condition or disease |
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Unexplained Infertility Polycystic Ovarian Syndrome Male Infertility |

Study Type : | Observational [Patient Registry] |
Actual Enrollment : | 118 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Target Follow-Up Duration: | 3 Weeks |
Official Title: | Endocrine Disrupting Chemicals: Potential Effects on Male and Female Reproductive Health in Saskatchewan. |
Study Start Date : | March 2012 |
Actual Primary Completion Date : | September 2014 |
Actual Study Completion Date : | January 2015 |

Group/Cohort |
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Unexplained (male)
Men of couples with a diagnosis of Unexplained infertility (n=15)
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Unexplained (female)
Women of couples with a diagnosis of Unexplained infertility (n=15)
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male factor (male)
Men of couples with a diagnosis of male factor infertility (n=15)
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male factor (female/control)
Women of couples with a diagnosis of male factor infertility (n=15)
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PCOS (female)
Women of couples with a diagnosis of Polycystic Ovarian Syndrome-related infertility (n=15)
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PCOS (male/control)
Men of couples with a diagnosis of Polycystic Ovarian Syndrome-related infertility (n=15)
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healthy volunteer (male/control)
Men with a history of no reproductive dysfunction and proven fertility (n=15)
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healthy volunteer (female/control)
Women with a history of no reproductive dysfunction and proven fertility (n=15)
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- Exposure to BPA [ Time Frame: March 2012 to September 2013 (up to 2 years) ]Concentrations of Bisphenol A (BPA), di-2-ethylhexyl phthalate (DEHP), di-n-octyl phthalate (DNOP), di-n-butyl phthalate (DNBP), n-butyl benzyl phthalate (BBP), diethyl phthalate (DEP), diisononyl phthalate (DINP) and diisodecyl phthalate (DIDP) will be quantified in the blood cells, blood plasma, and follicular fluid (individual and pooled samples) by use of liquid chromatography and tandem mass spectrometry methods and will be compared between study groups using multivariate Analyses of Variance (ANOVA).
- Exposure to Phthalates [ Time Frame: March 2012 to Sep. 2013 (up to 2 years) ]Exposure to phthalates will be determined by quantifying concentrations of 5 different pthalates. Concentrations of BPA and phthalates in blood cells, blood plasma, seminal plasma and pooled follicular fluid will be compared between study groups using multivariate Analyses of Variance (ANOVA).
Biospecimen Retention: Samples With DNA

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Ages Eligible for Study: | 18 Years to 43 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Probability Sample |
Inclusion Criteria:
- Age: 18-43 years
- Couples undergoing IVF for:
Unexplained infertility Male factor infertility Polycystic Ovary(PCOS)
-Both male and female partners must agree to participate
Exclusion Criteria:
- Age: <18 and >43 years
- Couples with both male and female factor infertility
- Only female or male partner agrees to participate

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02272439
Canada, Saskatchewan | |
Obstretrics, Gynecology and Reproductive Science, RUH | |
Saskatoon, Saskatchewan, Canada, S7N0W8 |
Principal Investigator: | Angela Baerwald, PhD | Assistant Professor |
Responsible Party: | Angela Baerwald, Assistant Professor, University of Saskatchewan |
ClinicalTrials.gov Identifier: | NCT02272439 |
Other Study ID Numbers: |
EDC-ARB-002 |
First Posted: | October 23, 2014 Key Record Dates |
Last Update Posted: | December 21, 2015 |
Last Verified: | December 2015 |
Bisphenol A phthalates infertility human |
Polycystic Ovary Syndrome Infertility Infertility, Male Ovarian Cysts Cysts |
Neoplasms Ovarian Diseases Adnexal Diseases Gonadal Disorders Endocrine System Diseases |