KARU-FERTIL: Chlordecone Exposure and Female Fertility
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 634
- 试验地点
- 1
- 主要终点
- Levels of AMH according to terciles of chlordecone levels.
研究概览
简要总结
Chlordecone is an organochlorine pesticide used in the French West Indies (FWI) from 1972 to 1993 to control the banana root borer. Due to its very long persistence the population continues to be exposed to this chemical through their food consumptions. Although, chlordecone have been associated in animal study impairment of ovarian reserve, to date, no study has been published concerning the link between chlordecone exposure and female fertility. The main objective of this project is to study the association between chlordecone exposure and anti-mullerian hormone (AMH) in women consulting for couple infertility in Guadeloupe.
详细描述
Chlordecone is an organochlorine pesticide used in the French West Indies (FWI) from 1972 to 1993 to control the banana root borer. Due to its very long persistence the population continues to be exposed to this chemical through their food consumptions. Chlordecone is an endocrine-disrupting chemical with well-defined estrogenic and progestagenic properties in vivo and in vitro. To date, no study has been published concerning the link between chlordecone exposure and female fertility. Nevertheless, mammalian studies in females have consistently reported that chlordecone exposure impairs ovulation and leads to a reduced ovarian reserve. In addition, there are questions about the impact of other environmental exposures, including by non-targeted approaches, and also of the vaginal and endometrial microbiome on female fertility.
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 39 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged from 18 to 39 years
- •Consulting for couple infertility at the Centre Caribéen de Médecine de la Reproduction (CCMR, Caribbean Center for Reproductive Medicine) of the University Hospital of Guadeloupe
- •Free, informed and written consent
排除标准
- •Women aged from 18 to 39 years
- •Consulting for couple infertility at the Centre Caribéen de Médecine de la Reproduction (CCMR, Caribbean Center for Reproductive Medicine) of the University Hospital of Guadeloupe
- •Free, informed and written consent
结局指标
主要结局
Levels of AMH according to terciles of chlordecone levels.
时间窗: AMH levels will be measured during the assessment conducted for assisted reproductive technology (ART) and will date from less than one year before inclusion
The purpose is to study the association between chlordecone exposure and AMH levels in women consulting for couple infertility in Guadeloupe.
次要结局
- Number of antral follicles according to terciles of chlordecone levels.(between days 2 and 4 of the spontaneous menstrual cycle)
- AMH levels and antral follicle count according to the levels of other POPs(baseline)
- relationship between exposure to chlordecone and other POPs and the risk of the main causes of female infertility(baseline)
- Chlordecone levels according to the outcomes of IVF/ICSI management:(changes from baseline to 2 years after)