The Human Sperm Survival Assay (HSSA) as an Internal Quality Control for the IVF Consumables
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 826
- 试验地点
- 2
- 主要终点
- Presence of embryotoxicity
研究概览
简要总结
The main embryotoxicity quality controls are the mouse embryo test (MEA = Mouse Embryo Assay) and the human sperm survival test (HSSA = Human Sperm Survival Assay). The HSSA test measures the survival (or mobility) of human sperm after exposure to the tested consumable for a predetermined period of time and compares it to that of unexposed sperm. It would appear that the HSSA is comparable in terms of sensitivity to the MEA test for the detection of toxicity.
详细描述
The main objective is to assess the embryotoxicity of the main IVF consumables using the HSSA test before their introduction to the IVF laboratory.
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 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male over 18 years-old
- •Normal spermogram (concentration ≥15 million / ml or total count> 39 million, progressive mobility ≥32% or total mobility ≥40%)
- •Progressive mobility ≥70% after selection
- •Total number of progressive motile spermatozoa recovered after TMS> 10 million
- •Patient affiliated or beneficiary of a social security scheme
- •Patient having been informed and not opposing to this research.
排除标准
- •Male over 65 years-old
- •Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision
结局指标
主要结局
Presence of embryotoxicity
时间窗: 1 day
Presence of embryotoxicity, defined by a mobility index relative to the control (SMI) \<0.85 observed on at least 2 of the three tests carried out on consumables from the same batch (isolated embryotoxicity).
次要结局
未报告次要终点