Evaluating the Efficacy of Exosome-Enriched Culture Media to Enhance In Vitro Maturation and Embryo Development in Poor Ovarian Responders Undergoing IVF: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Proportion of MI Oocytes Achieving MII Maturation
研究概览
简要总结
Evaluating the Efficacy of Exosome-Enriched Culture Media to Enhance In Vitro Maturation and Embryo Development in Poor Ovarian Responders Undergoing IVF
Summary:
This is a prospective, randomized controlled trial designed to assess whether supplementing standard IVF culture media with exosomes can improve the short-term in vitro maturation (IVM) of immature MI oocytes in poor ovarian responder patients.
Sixty women aged 35-42 who meet Bologna criteria for poor ovarian response will be recruited and randomized into two groups:
Control group: MI oocytes cultured in standard IVF media.
Intervention group: MI oocytes cultured in IVF media supplemented with 10 µg of GMP-certified exosomes per well.
The primary outcome is the proportion of MI oocytes maturing to MII within 4 hours. Secondary outcomes include fertilization rates, embryo quality, blastocyst development, and clinical pregnancy rates.
This study aims to explore a novel approach to improving oocyte yield and embryo development in poor responder IVF cycles, potentially reducing the need for repeated treatments and enhancing patient outcomes.
详细描述
This is a prospective, single-center, randomized controlled trial designed to evaluate the efficacy of exosome-enriched culture media in promoting the short-term in vitro maturation (IVM) of immature oocytes retrieved from poor ovarian responder patients undergoing in vitro fertilization (IVF).
Rationale:
Poor ovarian responders represent a significant clinical challenge in assisted reproductive technology (ART), often yielding a low number of mature metaphase II (MII) oocytes after controlled ovarian stimulation. A substantial proportion of oocytes retrieved in these patients remain at the metaphase I (MI) stage and traditionally show limited capacity for maturation, thereby reducing the pool of oocytes available for fertilization.
Emerging preclinical data and our pilot observations suggest that exosomes-extracellular vesicles containing bioactive molecules such as miRNAs, proteins, and growth factors-play a crucial role in follicular development and may facilitate oocyte meiotic progression. Incorporating exosomes into IVF culture media could therefore represent a novel strategy to enhance in vitro maturation of MI oocytes and improve outcomes in this difficult-to-treat population.
Study Design and Methods:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
盲法说明
"Not applicable. No additional parties are masked in this trial."
入排标准
- 年龄范围
- 35 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Inclusion Criteria:
- •Women aged 35 to 42 years
- •Undergoing IVF with an antagonist protocol
- •Meet at least two Bologna criteria for poor ovarian response
- •Provide written informed consent -
排除标准
- •Exclusion Criteria:
- •Severe male factor infertility requiring surgical sperm retrieval
- •Known untreated hydrosalpinx
- •Uterine anomalies that impair implantation
- •Known chromosomal abnormalities
- •Participation in another investigational study within 3 months
研究组 & 干预措施
Ovarian Stimulation with MI Oocyte Allocation to Exosome vs. Standard Media
All participants undergo controlled ovarian stimulation and oocyte retrieval following a standard antagonist protocol. Retrieved MI oocytes from each patient are then allocated to two different in vitro culture conditions: (1) standard IVF media, and (2) IVF media supplemented with 10 µg of GMP-certified exosomes per well. This design allows within-patient comparison of oocyte maturation, fertilization, and embryo development outcomes under the two culture environments.
干预措施: Exosome-Enriched IVF Culture (Procedure)
结局指标
主要结局
Proportion of MI Oocytes Achieving MII Maturation
时间窗: Within 4 hours post-culture
The primary outcome is the percentage of retrieved MI oocytes that progress to MII after 2-4 hours of culture in exosome-enriched versus standard IVF media. Oocyte maturation is assessed morphologically under an inverted microscope.
次要结局
- Fertilization Rate(18-20 hours post-ICSI)