Prospective, Multicenter, Randomized Clinical Trial Evaluating the Safety of the HyperSperm Sperm Preparation Procedure.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 202
- 试验地点
- 2
- 主要终点
- Euploidy Rate
研究概览
简要总结
Prospective, multicenter, randomized clinical study evaluating the safety of a novel sperm preparation method for in vitro fertilization (IVF), compared to standard sperm preparation 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 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Couples undergoing in vitro fertilization (IVF) treatment.
- •Planned use of fresh sperm samples obtained by masturbation.
- •Age between 20 and 42 years.
- •Antral follicle count ≥
- •Eligible for ovarian stimulation and embryo transfer.
- •Age between 20 and 45 years.
- •Fresh semen sample (not cryopreserved).
- •Pre-processing sperm concentration ≥ 5 × 10⁶ sperm/mL.
排除标准
- •Active sexually transmitted infection (STI).
- •Use of donor sperm.
- •Medical conditions contraindicating pregnancy or the IVF procedure.
- •Uterine anomalies associated with distortion of the uterine cavity.
- •Absence of one ovary or functional disorders preventing ovulation.
- •Diabetes mellitus or other metabolic disorders.
- •Recurrent pregnancy loss, defined as more than two clinical pregnancies without live birth.
- •- Any medical condition affecting semen quality that, in the investigator's opinion, may interfere with study participation.
研究组 & 干预措施
Standard Sperm Preparation
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
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
Euploidy Rate
时间窗: From embryo biopsy and PGT analysis up to completion of genetic results, within the IVF cycle (approximately 5-7 days post-fertilization).
Proportion of embryos identified as euploid following preimplantation genetic testing (PGT) performed on embryos generated during the IVF cycle.
次要结局
- Fertilization Rate(Approximately 16-20 hours after insemination.)
- Cleavage Rate(Day 2-3 after fertilization.)
- Blastocyst Formation Rate(Day 5-6 after fertilization.)
- Embryo Quality at Cleavage Stage(Day 3 after fertilization.)
- Embryo Quality at Blastocyst Stage(Day 5-6 after fertilization.)
- Biochemical Pregnancy Rate(Approximately 10-14 days after embryo transfer.)
- Clinical Pregnancy Rate(5-7 weeks of gestation following embryo transfer.)
- Progressive Motile Sperm Count After Processing(Immediately after sperm processing on the day of oocyte retrieval.)
- Total Sperm Motility After Processing(Immediately after sperm processing on the day of oocyte retrieval.)
- Progressive Sperm Motility After Processing(Immediately after sperm processing on the day of oocyte retrieval.)