Influence of Sperm With Large Nuclear Vacuoles on the Cycles' Outcomes of Couples Couples Undergoing ICSI
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Pregnancy
研究概览
简要总结
Current research on sperm morphology has been directed towards the dysmorphisms of the sperm head. A new technique based on the motile sperm organelle morphology examination (MSOME) allows the detection of sperm with large nuclear vacuoles (SLV). Large nuclear vacuoles are specific sperm alterations observed under high magnification, and their presence has been related to increased DNA fragmentation and denaturation.
详细描述
A new method for the detailed morphological evaluation of motile spermatozoa in real time, under high magnification, named "motile sperm organellar morphology examination" (MSOME) was developed. This magnification provides an accurate description of spermatozoa abnormalities, particularly the presence of head vacuoles, which is indicative of abnormal chromatin packaging in spermatozoa. However, the influence of sperm with large nuclear vacuoles (SLV) on ART outcomes is still a matter of debate. The goals for this study were to identify whether there is a connection between SLV under high magnification and ICSI outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Couples undergoing intracytoplasmic sperm injection (ICSI) as result of male factor or tubal factor or unexplained infertility
- •Women with regular menstrual cycles of 25-35 days
- •Women with normal basal follicle stimulating hormone (FSH) and luteinizing hormone (LH) levels
- •Women with body mass index (BMI) less than 30 kg/m2
- •Women with both ovaries and intact uterus
排除标准
- •Women with polycystic ovaries syndrome
- •Women with endometriosis
- •Women with gynaecological/medical disorders
- •Couples with any sexually transmitted disease
- •Women who had received any hormone therapy for less than 60 days preceding the study
结局指标
主要结局
Pregnancy
时间窗: 1 month
Number of clinical pregnancy rate divided by the number of couples in which embryo transfer was performed
次要结局
未报告次要终点