The Effect of the Intracytoplasmic Morphologically Selected Sperm Injection in Couples With Previous Implantation Failure After Intracytoplasmic Sperm Injection
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Implantation
研究概览
简要总结
There is a lack of clarity regarding the justification to instruct the couple to shift from intracytoplasmic sperm injection (ICSI) to intracytoplasmic morphologically selected sperm injection (IMSI). In this study, we aim at evaluating the efficacy of IMSI in couples with previous implantation failure with ICSI.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 38 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with ICSI indication, who have previously underwent >= 1 ICSI attempt in which at least 2 blastocysts were transferred, with no implantation.
- •Regular menstrual cycles every 25-35 days.
- •Body Mass Index less than 35 as calculated according to the following formula: body weight (kg) / height x height (m2)
- •Presence of both ovaries.
- •No pelvic and / or clinically significant uterine anomalies.
- •Normal cervical cytology.
- •Serum follicle stimulating hormone (FSH) within normal limits.
排除标准
- •Clinically significant systemic disease.
- •Infection by the human immunodeficiency virus (HIV).
- •Infection by the by the hepatitis C virus
- •Positive test for surface antigens of hepatitis B.
- •Endometriosis stages III - IV (classification of the American Society for Reproductive Medicine).
- •Hydrosalpinx, unilateral or bilateral.
- •Abnormal gynecological bleeding, undiagnosed.
- •Allergy or hypersensitivity to human gonadotropin preparations or any other related to the study medication.
- •Simultaneous participation in another clinical trial. -
研究组 & 干预措施
ICSI group
In this group, sperm selected for injection will be morphologically evaluated under 400x magnification
干预措施: Intracytoplasmic sperm injection (Other)
IMSI group
In this group, sperm selected for injection will be morphologically evaluated under 6600x magnification
干预措施: Intracytoplasmic morphologically selected sperm injection (Other)
结局指标
主要结局
Implantation
时间窗: 4-5 weeks' gestation
The presence of a gestational sac with heart beat, visualized upon ultrasound scan at 4-5 weeks' gestation
次要结局
未报告次要终点