The Benefits of Intracytoplasmic Morphologically Selected Sperm Injection (IMSI) in Couples With Unexplained Infertility
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Pregnancy rate
研究概览
简要总结
The (motile sperm organelle morphology examination) MSOME allows the detection of sperm vacuoles that seems to be related to sperm DNA damage.
The investigators hypothesized that couples with unexplained infertility could benefit from the injection of spermatozoa selected under high-magnification (x6600)
详细描述
When routine infertility workup yields normal results in both partners, the couple is defined as suffering from unexplained infertility. These couples present normal semen analysis.
It has been reported that even infertile patients with normozoospermic parameters can have higher values of DNA damage than fertile controls.
It has been proposed that the use of ''invisible damaged'' spermatozoa could result in fertilization failure, impaired normal embryo development, reduced implantation and pregnancy rates.
The motile sperm organelle morphology examination (MSOME) allows the detection of sperm vacuoles that seems to be related to sperm DNA damage.
The investigators hypothesized that couples with unexplained infertility could benefit from the injection of spermatozoa selected under high-magnification (x6600)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 36 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women of good physical and mental health
- •Undergoing assisted reproduction as a result of 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
- •Men with abnormal semen parameters according to the 2010 WHO values
- •Women with polycystic ovaries
- •Women with endometriosis
- •Women with gynaecological/medical disorders
- •Women or men with a positive result for sexually transmitted diseases
- •Women who had received hormone therapy for at least 60 days preceding the study
研究组 & 干预措施
ICSI
In this arm, patients will be provided with standard intracytoplasmic sperm injection (ICSI), in which sperm selection is performed under an overall magnification of x400.
干预措施: ICSI (Other)
IMSI
In this arm, patients will be provided with a modified intracytoplasmic sperm injection (ICSI) procedure, the IMSI, in which sperm selection is performed under an overall magnification of x6600.
干预措施: IMSI (Other)
结局指标
主要结局
Pregnancy rate
时间窗: 1 month
Number of pregnancies divided by the number of cycles with embryo transfer
次要结局
未报告次要终点