NCT05680363已完成不适用
Prospective Sibling Oocyte Study of a New Method to Improve Embryo Development in IVF/ICSI Patients
Fecundis S.A.4 个研究点 分布在 1 个国家目标入组 41 人开始时间: 2023年5月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 41
- 试验地点
- 4
- 主要终点
- Development rate to blastocysts
研究概览
简要总结
Prospective, multi-centric, split-sample, sibling oocyte study evaluating the safety and efficacy of a new method to prepare sperm samples for IVF (in vitro fertilization) / ICSI (intracytoplasmic sperm injection) compared to standard procedures.
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
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 41 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion Criteria:
- •With ovarian reserve of between 8 and 30 antral follicles counting both ovaries
- •Treatment planned for embryo transfer at the blastocyst stage
排除标准
- •Any diagnosed sexually transmitted infection (STI)
- •Diabetes or other metabolic disorders.
- •Recurrent pregnancy loss (defined as >2 clinical pregnancies without live birth).
- •Previous failures in two or more IVF cycles
- •Inclusion Criteria for IVF:
- •Age: 20-55 years
- •Fresh sample (not cryopreserved )
- •Sperm motility (TOTAL) ≥ 40% in spermogram
- •Normal sperm morphology (Kruger criteria) ≥ 4% in spermogram
- •Sperm count after swim up ≥ 5x10^6
- •Treatment planned for embryo transfer at the blastocyst stage
- •Inclusion Criteria for ICSI:
- •Age: 20-55 years
- •Fresh sample (not cryopreserved )
- •Sperm concentration ≥ 10x10^6 /ml in spermogram
- •Sperm motility (TOTAL) ≥ 20% in spermogram
- •Normal sperm morphology (Kruger criteria) ≥ 3% in spermogram
- •Treatment planned for embryo transfer at the blastocyst stage
- •Exclusion Criteria:
- •Any diagnosed sexually transmitted infection (STI)
- •Total failure of in vitro fertilization in previous cycles.
研究组 & 干预措施
Standard Sperm Preparation
Active Comparator
Sperm samples in the control group will undergo traditional processing in the lab prior to insemination.
干预措施: Standard Sperm Preparation (Device)
HyperSperm
Experimental
Sperm samples in the experimental group will undergo product-specific processing in the lab prior to insemination.
干预措施: HyperSperm (Device)
结局指标
主要结局
Development rate to blastocysts
时间窗: Days 5-6 post insemination
Total blastocysts / total fertilized oocytes
次要结局
- Fertilization rate(Day 1 post insemination)
研究者
研究点 (4)
Loading locations...
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