Randomized Non-inferiority Within-Patient Trial of Density Gradient Processing of Sequential Ejaculates Versus Centrifugation-free Sperm Separation Device for ICSI in Men With Elevated Sperm DNA Fragmentation.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 830
- 试验地点
- 9
- 主要终点
- Ongoing Pregnancy Rate
研究概览
简要总结
Elevated SDF can adversely impact fertilization, embryo development, and pregnancy outcomes in IVF-ICSI cycles. Two pragmatic strategies aim to reduce SDF on the day of ICSI: (i) obtaining a second ejaculate shortly after the first to reduce oxidative damage and transit time; and (ii) selecting sperm via centrifugation-free sperm separation device, which enriches for motile sperm with intact DNA. There are limited direct comparisons between these strategies; this study addresses that gap.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Elevated SDF defined as DFI >20 %measured by the sperm chromatin dispersion (SCD) test performed in a participating center's andrology laboratory, using a harmonized protocol under standardized conditions after 2-3 days of ejaculatory abstinence, and within 90 days (≤3 months) prior to enrollment.
- •Male partners 21-45 years;
- •Female partners 21-35 years.
- •Undergoing IVF/ICSI.
- •No known genetic or chromosomal abnormalities.
- •Minimum 4 MII oocyte patients shall be included
排除标准
- •Azoospermia or severe oligoasthenozoospermia (<1 million motile sperm/mL).
- •Significant systemic disease (e.g., uncontrolled diabetes, malignancy).
- •History of a prior ICSI cycle with no embryo development.
- •Relevant female factors: untreated adnexal pathology ,a history of a thin endometrium (<7 mm) following endometrium preparation for embryo transfer
研究组 & 干预措施
First Ejaculate
Processed using a centrifugation-free sperm sorting device
干预措施: Processed using density gradient centrifugation (Procedure)
Second Ejaculate
The second ejaculate will be processed with two-layer density gradient centrifugation followed by standard washing.
干预措施: Second Ejaculate (collected after 1-3 hours) (Procedure)
结局指标
主要结局
Ongoing Pregnancy Rate
时间窗: 12 weeks of gestation
Ongoing pregnancy rate
次要结局
- Good Blastocyst rate(Day 5&6 after ICSI)
- Sperm motility and morphology after sperm sorting or second ejaculate collection.(At the day of ICSI)
- Blastocyst rate(Day 5&6 after ICSI)
- Biochemical Pregnancy Rate(2 weeks after embryo transfer)
- Implantation Rate(4-6 weeks after embryo transfer)
- Clinical Pregnancy Rate(4-6 weeks after embryo transfer)
- First trimester Miscarriage Rate(Till 12 weeks after embryo transfer)
研究者
Dr Vipin Chandra
Chief Clinical and Lab Operations
Indira IVF Hospital Pvt Ltd