跳至主要内容
临床试验/NCT01731639
NCT01731639已完成不适用

The Influence of Motile Sperm Organelle Morphology Examination on ICSI Outcomes

Sapientiae Institute2 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2013年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
72
试验地点
2
主要终点
Pregnancy rates

研究概览

简要总结

A new technique based on the motile sperm organelle morphology examination (MSOME) at a magnification of at least ×6000 has been developed. The MSOME assesses the nucleus, for both shape and chromatin content, which is the most important sperm organelle in influencing intracytoplasmic sperm injection (ICSI) outcomes.

详细描述

Sperm morphology has been described as one of the major determinants of male in vitro fertility. However, the standard morphology evaluation on random stained cells from the ejaculate is of limited value during ICSI. Current research is directed towards the dysmorphisms of the sperm head.A new technique based on the motile sperm organelle morphology examination (MSOME) at a magnification of at least ×6000 has been developed. The MSOME assesses the nucleus, for both shape and chromatin content, which is the most important sperm organelle in influencing ICSI outcomes. The goals for this study are to identify whether there is a connection between morphologic sperm normalcy under high magnification and (i) semen analysis according to the new World Health Organization (WHO) reference values and (ii) 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

入选标准

  • Couples undergoing 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

研究组 & 干预措施

MSOME

Experimental

The samples will be evaluated under high magnification

干预措施: MSOME (Other)

结局指标

主要结局

Pregnancy rates

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

  • Implantation rates(1 month)

研究者

发起方
Sapientiae Institute
申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验