Endocrine Disrupting Chemicals: Potential Effects on Male and Female Reproductive Health in Saskatchewan.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 118
- 试验地点
- 1
- 主要终点
- Exposure to BPA
研究概览
简要总结
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
详细描述
Study Sample:
Couples undergoing in vitro fertilization (IVF) and/or Intracytoplasmic Sperm Injection (ICSI) for assisted reproduction at ARTUS as well as healthy male and female volunteers 18-43 years of age will be asked to participate. In order for infertility patients to be eligible, both the male and female partners must agree to participate. Couples with a combination of both male and female factor infertility will not be eligible to participate. Couples undergoing infertility treatment for the following reasons will be evaluated:
- unexplained infertility (n=15 men, n=15 women)
- PCOS (n=15 men, n=15 women)
- Male factor infertility (n=15 men, n=15 women)
Couples with male factor infertility will serve as controls for the female comparisons (i.e., follicular fluid analyses), and couples with PCOS will serve as controls for the male comparisons (i.e., seminal plasma analyses).
Additional participants will be assigned to the following control groups (for blood sample analyses):
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 43 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •Age: <18 and >43 years
- •Couples with both male and female factor infertility
- •Only female or male partner agrees to participate
结局指标
主要结局
Exposure to BPA
时间窗: 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).
次要结局
- Exposure to Phthalates(March 2012 to Sep. 2013 (up to 2 years))
研究者
Angela Baerwald
Assistant Professor
University of Saskatchewan