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临床试验/NCT07020546
NCT07020546招募中不适用

Ovarian Platelet-Rich Plasma (oPRP) Injections Improvement In IVF Patients Based On Time-Lapse Incubator Culture for Automated Tracking and AI for Embryo Quality Assessment : A Non-Randomized Propsective Self-Controlled Interventional Study

Generation Next Fertility1 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2025年7月8日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
180
试验地点
1
主要终点
Blastocyst formation and embryo quality

研究概览

简要总结

Patients will have ovarian PRP treatments and embryo development will be observed using time-lapse imaging and AI software.

详细描述

. oPRP Treatment & Second IVF Cycle (Study Cycle)

  • Following the first IVF cycle, patients will undergo their first oPRP injection:

  • Timing: 1-2 weeks after the onset of the next menstrual cycle.

  • Procedure: Under IV sedation, a patient's autologous PRP will be prepared and injected directly into both ovaries under transvaginal ultrasound guidance.

  • Second IVF Cycle (oPRP Study Cycle)

  • The same ovarian stimulation protocol will be used for consistency.

  • A second oPRP injection will be performed on stimulation days 2-5 to enhance folliculogenesis.

  • Ovulation will be triggered at the same follicular size thresholds, and oocyte retrieval will follow identical protocols.

  • Fertilization methodology will be identical to the first cycle unless no fertilization is identified in the first cycle.

  • Embryo Development Analysis: Up to 15 embryos will be cultured in the AI incubator, where time-lapse imaging will track their morphokinetics, and AI-based analysis will assess embryo viability and implantation potential.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 47 Years(Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •No none contraindications to IVF or PRP treatment
  • •Adequate ovarian reserves and AMH level
  • •Willingness to undergo two IVF cycles and oPRP treatment

排除标准

  • •Anovulation due to menopause or perimenopause
  • •Any health conditions that are contraindicated for IVF or oPRP treatment

研究组 & 干预措施

Embryo Development Before and After Ovarian PRP Using Time-Lapse AI Embryo Quality Score

Experimental

Patients will undergo two IVF cycles. The first cycle will be before ovarian PRP treatment and the second will be after. The embryo development measured by data gathered in time-lapse imaging and AI software will be used to determine differences between the groups within the same patient

干预措施: Ovarian Platelet-rich plasma (PRP) injections (Procedure)

结局指标

主要结局

Blastocyst formation and embryo quality

时间窗: 1 year

The number of high quality embryos that are created per cycle

次要结局

  • Live birth rate per transfer(2 years)

研究者

发起方
Generation Next Fertility
申办方类型
Other
责任方
Sponsor

研究点 (1)

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