HAP-REPRO: IMPACT OF POLYCYCLIC AROMATIC HYDROCARBONS (PAH) ON IN VITRO FECONDATION: PARENTAL CELLS WITH EARLY EMBRYONIC QUALITY.
试验速览
- 阶段
- 不适用
- 入组人数
- 220
- 试验地点
- 2
- 主要终点
- expired CO
研究概览
简要总结
The main objective of this study is to highlight a relationship between exposure to PAHs, genotoxic effect biomarkers on spermatozoa and follicular cells, as well as embryonic quality and embryo implantation rates at a given time. IVF attempt. This study therefore analyzes the possibility of using this exposure biomarker as a reliable means of evaluating the quality of gametes in order to estimate the chances of success in IVF.
详细描述
Objective assessment of the effect of environmental and occupational factors on fertility is difficult to establish due to the lack of relevant exposure biomarkers for reporting multi-exposures.
The main objective of this study is to highlight a relationship between exposure to PAHs, genotoxic effect biomarkers on spermatozoa and follicular cells, as well as embryonic quality and embryo implantation rates at a given time. IVF attempt. This study therefore analyzes the possibility of using this exposure biomarker as a reliable means of evaluating the quality of gametes in order to estimate the chances of success in IVF.
Subsequently, the results of this study will make it possible to personalize and evaluate the effectiveness of the preventive measures put in place upstream of the MPA route by allowing To identify a relationship between PAH exposure and sperm DNA gamete quality in humans, serum AMH concentration and ovarian response to gonadotropic stimulation for IVF in women.
To highlight a relationship between individual exposures to complex PAH mixtures and infertility.
The methodology based, on the feminine side, on the analysis of follicular cells makes it possible to study cells close to female gametes within the cumulo-oocyte complex, without losing the chance of pregnancy for the couple.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 36 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Couples whose wife is under 36 and the man under 45 at the time of IVF
- •Regular cycles of 27 to 33 days in women
- •Management of classical IVF (without the use of micro-sperm injection)
- •1st or 2nd attempt of IVF
- •Signature of informed consent by both partners of the couple
- •Affiliation to a social security scheme or equivalent for both partners of the couple.
排除标准
- •Refusal to participate in the study of one or both members of the couple
- •No fluency in French
- •History likely to alter the ovarian reserve, endometriosis
- •Uterine or systemic antecedents, likely to affect implantation
- •Andrological antecedents likely to alter fertilization rates
- •History of chemotherapy / radiotherapy
- •Positive plasma viral load for HIV, HCV or HBV in the year prior to inclusion in one of the members of the couple
研究组 & 干预措施
Exposed
Urinary level of 1-hydroxypyrene, the most sensitive biomarker of PAH exposure greater than 0.1 μmol / mol creatinine
干预措施: IN VITRO FERTILIZATION (Biological)
Not exposed
Urinary level of 1-hydroxypyrene, the most sensitive marker of PAH exposure below 0.1 μmol / mol creatinine
干预措施: IN VITRO FERTILIZATION (Biological)
结局指标
主要结局
expired CO
时间窗: 72 hours
The night before the IVF, a urine sample will be collected from both members of the couple, according to the protocol published by the team Partner 2. On the day of the IVF, a measurement of the exhaled CO rate will be carried out by the two members of the couple according to the recommendations of the manufacturer.
次要结局
未报告次要终点