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Endocrine Disrupting Chemicals: Potential Effects on Male and Female Reproductive Health in Saskatchewan

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02272439
Recruitment Status : Completed
First Posted : October 23, 2014
Last Update Posted : December 21, 2015
Sponsor:
Collaborator:
Royal University Hospital Foundation
Information provided by (Responsible Party):
Angela Baerwald, University of Saskatchewan

Brief Summary:

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:

  1. Serum BPA and/or phthalate concentrations will be greater in women with unexplained infertility or PCOS compared to a control group
  2. Serum BPA and/or phthalate concentrations will be greater in men with male factor infertility compared to a control group

Condition or disease
Unexplained Infertility Polycystic Ovarian Syndrome Male Infertility

Show Show detailed description

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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
Unexplained (male)
Men of couples with a diagnosis of Unexplained infertility (n=15)
Unexplained (female)
Women of couples with a diagnosis of Unexplained infertility (n=15)
male factor (male)
Men of couples with a diagnosis of male factor infertility (n=15)
male factor (female/control)
Women of couples with a diagnosis of male factor infertility (n=15)
PCOS (female)
Women of couples with a diagnosis of Polycystic Ovarian Syndrome-related infertility (n=15)
PCOS (male/control)
Men of couples with a diagnosis of Polycystic Ovarian Syndrome-related infertility (n=15)
healthy volunteer (male/control)
Men with a history of no reproductive dysfunction and proven fertility (n=15)
healthy volunteer (female/control)
Women with a history of no reproductive dysfunction and proven fertility (n=15)



Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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
Blood, Follicular Fluid and Seminal Plasma Samples


Information from the National Library of Medicine

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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
Study Population
Infertile couples with unexplained infertility, male factor infertility and PCOS Healthy volunteers with history of fertility
Criteria

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

Information from the National Library of Medicine

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


Locations
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Canada, Saskatchewan
Obstretrics, Gynecology and Reproductive Science, RUH
Saskatoon, Saskatchewan, Canada, S7N0W8
Sponsors and Collaborators
University of Saskatchewan
Royal University Hospital Foundation
Investigators
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Principal Investigator: Angela Baerwald, PhD Assistant Professor

Additional Information:

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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
Keywords provided by Angela Baerwald, University of Saskatchewan:
Bisphenol A
phthalates
infertility
human
Additional relevant MeSH terms:
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Polycystic Ovary Syndrome
Infertility
Infertility, Male
Genital Diseases, Male
Genital Diseases, Female
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases
Endocrine Disruptors
Physiological Effects of Drugs