Outcome of ICSI Using Laser Assisted Sperm Selection of Viable Immotile Testicular Sperm in Azoospermic Infertile Men: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 168
- 试验地点
- 1
- 主要终点
- Clinical pregnancy rate
研究概览
简要总结
This study aims to investigate the outcome of ICSI after using LAISS for selection of viable immotile testicular sperm in azoospermic infertile men.
Patients will be randomly assigned to 2 groups. In (LAISS) group, viable immotile testicular sperms will be selected before ICSI using laser assisted immotile sperm selection (study group). In (HOST) group, viable immotile testicular sperms will be selected before ICSI using hypo-osmotic swelling test (control group).
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)
盲法说明
With an online tool, participants will be randomized to undergo ICSI with HOST and LAISS sperm selection arms with a 1:1 allocation ratio as per a computer-generated list, using permuted block sizes of 8, and 16, stratified for sites and fresh or cryopreserved sperm. Results of allocation will be in sealed opaque envelopes labeled with unique random codes. Clinicians, embryologists, and participants in all centers will have no access to allocation results. Upon consent, instructors will assign participants to the relevant group. Embryologists who will perform fertilization check and embryo grading will be unaware of the sperm selection method. Women will undergo only day 5 blastocysts transfer. This trial will also conceal the allocation from participants and clinical team.
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligible couples are those undergoing ICSI due to azoospermia with testicular biopsy positive for sperm (either fresh or cryopreserved) following testicular sperm extraction (TESE) or aspiration (TESA).
排除标准
- •Cases with female factor infertility or woman age above 35 years will be excluded.
研究组 & 干预措施
LAISS group
Viable immotile testicular sperms will be selected before ICSI using laser assisted immotile sperm selection (study group).
干预措施: Laser Assisted Immotile Sperm Selection (Device)
HOST group
Viable immotile testicular sperms will be selected before ICSI using hypo-osmotic swelling test (control group).
干预措施: Hypo-osmotic Swelling Test (Procedure)
结局指标
主要结局
Clinical pregnancy rate
时间窗: 6- 7 weeks
Presence of a fetal heartbeat at 6-7 weeks of pregnancy.
次要结局
未报告次要终点
研究者
Mohamed Alaa El-Dein Hasan
Assistant Lecturer of Dermatology, Venreology and Andrology
Sohag University