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临床试验/NCT02377219
NCT02377219终止不适用

Bisphenol A Exposure, Ovarian Function and Assisted Reproductive Technology Outcome.

University Hospital, Toulouse10 个研究点 分布在 1 个国家目标入组 350 人开始时间: 2014年10月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
350
试验地点
10
主要终点
embryo implantation rate

研究概览

简要总结

Our goal is to prospect the relationships between Bisphenol A (BPA) exposure (measured as its free and conjugated forms in blood and urine) and embryo implantation rate (measured as the ratio between the number of gestational sacs and the number of transferred embryos) after assisted reproductive technology. In order to reduce the confusion factors, the population study is limited to young women (aged 28 to 34), with regular menstrual cycles and without any medical event that could affect the implantation process

详细描述

Among the various suspected adverse effects of BPA on human health, studies on the possible effects of BPA on reproduction are limited. Animal and in vitro studies indicate that BPA exposure can lead to disrupted oocyte maturation, E2 suppression and early pregnancy loss caused by chromosomal abnormalities. In the woman, studies about the consequences of BPA exposure on reproduction is a very difficult task since gametogenesis in the woman spreads over decades, from the intra-uterine life where meiosis is initiated to the end of the reproductive period at menopause. Recently, a decreased survival of human foetal oocytes cultured in vitro in the presence of BPA has been shown suggesting that in vivo exposure in foetal life could affect the ovarian reserve. Furthermore, a negative association between urinary BPA level and serum peak E2, oocyte yield and blastocyst formation has been suggested on a limited population of women performing ART. These results suggest that, in adulthood, both quantity and quality of human oocytes could be affected by BPA exposures. The study aims to respond to these questions by evaluating the relationships between BPA exposition levels and embryo implantation rates (as a marker of oocyte quality) and anti-Mullerian hormon (AMH) levels (as a marker of ovarian reserve) in large population of young adult women performing ART. BPA exposure will be assessed at two times in both blood and urine: 1°) before the ovarian stimulation at the time of ovarian reserve tests and 2°) at the end of the ovarian stimulation the day of the ovarian puncture for IVF.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
28 Years 至 34 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Couples attending an IVF or ICSI attempt whose woman is aged 28 ans to 34 at inclusion time
  • Regular menstrual cycles (between 27 and 33 days)
  • 1st or 2nd IVF or ICSI attempt with an embryo transfer at D2 or D3

排除标准

  • couple already included in the study
  • ovarian surgery history
  • uterine (malformation, diethylstilbestrol (DES) syndrome, adenomyosis...) or systemic pathology that can affect implantation (thrombophilia, antiphospholipids syndrome...)
  • chemotherapy history for the woman
  • any endocrinopathy (except dysthyroid) in the woman
  • any pelvic surgery for the woman in the 3 months preceding inclusion
  • endometriosis
  • ICSI with testicular sperm
  • Positive viral load for HIV, hepatitis C virus or hepatitis B virus (HCV or HBV) during the year preceding inclusion in one or both members of the couple

研究组 & 干预措施

couples

Experimental

couples attending an IVF or intra cytoplasmic sperm injection (ICSI) attempt have hormonal and blood analysis

干预措施: hormonal and blood analysis (Other)

结局指标

主要结局

embryo implantation rate

时间窗: 6 weeks after implantation

an ultrasonography between the 5th and 7th week after embryo transfer

次要结局

  • serum AMH(4 days after inclusion)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (10)

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