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临床试验/NCT07329998
NCT07329998进行中(未招募)不适用

Oocyte Quality Assessment Using Spectrophotometer

Hillel Yaffe Medical Center1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2024年9月22日最近更新:

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
200
试验地点
1
主要终点
Difference in follicular fluid infrared spectrophotometric profiles between high-quality and low-quality oocytes.

研究概览

简要总结

The aim of the study is to check whether follicular fluid evaluation using a spectrophotometer can differentiate high quality oocytes from low quality oocytes. Oocyte quality will be defined using GDF9, BMP15 and oocyte morphology. The correlation between cortisol levels in women and oocyte quality parameters will be estimated.

研究设计

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

入排标准

性别
Female
接受健康志愿者

入选标准

  • Women aged 20-40 years.
  • Undergoing IVF or IVF-ICSI treatment.
  • At least five follicles visualized on ultrasound at the time of oocyte retrieval
  • Ability to provide written informed consent.

排除标准

  • Age >40 years.
  • Fewer than five follicles at the time of oocyte retrieval.
  • Use of donor oocytes.
  • Significant medical comorbidities affecting ovarian function.
  • Known ovarian malignancy or prior ovarian surgery significantly affecting follicular integrity.

结局指标

主要结局

Difference in follicular fluid infrared spectrophotometric profiles between high-quality and low-quality oocytes.

时间窗: 3 Years

Infrared spectrophotometric measurements of follicular fluid collected at oocyte retrieval will be obtained using attenuated total reflection Fourier-transform infrared spectroscopy (ATR-FTIR). Oocytes will be classified as high-quality or low-quality based on predefined morphological criteria and follicular fluid levels of GDF9 and BMP15 measured by ELISA. The primary outcome will be reported as differences in normalized spectral absorbance features between the two oocyte quality groups, including discrimination performance using multivariate analysis.

次要结局

未报告次要终点

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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