NCT02272439

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
118

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2012

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

April 11, 2013

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 23, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

December 21, 2015

Status Verified

December 1, 2015

Enrollment Period

2.5 years

First QC Date

April 11, 2013

Last Update Submit

December 18, 2015

Conditions

Unexplained InfertilityPolycystic Ovarian SyndromeMale Infertility

Keywords

Bisphenol Aphthalatesinfertilityhuman

Outcome Measures

Primary Outcomes (1)

  • Exposure to BPA

    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).

    March 2012 to September 2013 (up to 2 years)

Secondary Outcomes (1)

  • Exposure to Phthalates

    March 2012 to Sep. 2013 (up to 2 years)

Study Arms (8)

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)

Eligibility Criteria

Age18 Years - 43 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • Age: \<18 and \>43 years
  • Couples with both male and female factor infertility
  • Only female or male partner agrees to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Obstretrics, Gynecology and Reproductive Science, RUH

Saskatoon, Saskatchewan, S7N0W8, Canada

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood, Follicular Fluid and Seminal Plasma Samples

MeSH Terms

Conditions

Polycystic Ovary SyndromeInfertility, MaleInfertility

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System DiseasesGenital Diseases, MaleMale Urogenital Diseases

Study Officials

  • Angela Baerwald, PhD

    Assistant Professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Weeks
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 11, 2013

First Posted

October 23, 2014

Study Start

March 1, 2012

Primary Completion

September 1, 2014

Study Completion

January 1, 2015

Last Updated

December 21, 2015

Record last verified: 2015-12

Locations

CA(1)