Trial to Improve Fertilization Rate and Embryo Development in Intracytoplasmic Sperm Injection (ICSI) Cycles
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- fertilization rate.
研究概览
简要总结
The Aim of the trial:
Assess if a consecutive second ejaculate contains an equal, or even higher number of motile sperm and produces high-quality sperm for intracytoplasmic sperm injection (ICSI) in male factor patients and if it will improve clinical outcomes, such as fertilization rate, embryo quality, number of blastocysts retrieved per cycle, implantation, and hopefully pregnancy rates.
详细描述
Background:
According to research, the length of abstinence has an impact on sperm DNA fragmentation (SDF) as well as sperm parameters. Long abstinence period increases the volume of semen and the concentration of sperm, but it will negatively impact motility, viability, and morphology.
The second ejaculation of males shows a considerable improvement in total motility and a significant decrease in (SDF) when it is collected within 1 to 3 hours of the first ejaculate.
it is essential to ensure the availability of high-quality spermatozoa with second ejaculation to enhance clinical results in ICSI cycles
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
- None
入排标准
- 年龄范围
- 25 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male: with abnormal semen parameter according to WHO.
- •Age range between 25-45 for both partners.
排除标准
- •Female with factors that might affect Oocyte quality:
- •Polycystic ovary (PCO). Poor ovarian reserve. Endometriosis.
- •- Male partners who need testicular biopsy to retrieve sperms.
研究组 & 干预措施
first ejaculate
In this arm, participants will undergo ICSI using sperm collected from the first ejaculate. Semen analysis will be conducted to assess sperm quality, including motility, morphology, and concentration. This arm will serve as the baseline for comparison with the second ejaculate arm.
干预措施: First Ejaculate for ICSI (Procedure)
Second Ejaculate
Participants in this arm will undergo ICSI using sperm collected from the second ejaculate, which will be obtained within a short interval (1-2 hours) after the first. Semen analysis will be conducted to compare sperm quality with that of the first ejaculate, and fertilization and embryo development outcomes will be evaluated
干预措施: Second Ejaculate for ICSI (Procedure)
结局指标
主要结局
fertilization rate.
时间窗: Periprocedural
Fertilization will be confirmed after 16-18 hours by the observation of two distinct pronuclei (2PN) and two polar bodies. The fertilization rate will be calculated as the number of fertilized oocytes divided by total number of mature oocytes (MII) for each couple. Oocytes with 2PN will be observed
次要结局
- Embryo development rate(periprocedural)
- semen analysis(Baseline)