Effects of Autologous Intraovarian Platelet Rich Plasma in Women With Poor Ovarian Response
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- Embryo number
研究概览
简要总结
Reproductive age women diagnosed with poor ovarian response (POR) based on Bologna criteria with a history of at least two prior failed ICSI cycle will be recruited for the study. Antral follicle count (AFC), serum anti-mullerian hormone (AMH), and early follicular phase serum follicle stimulating hormone (FSH) levels will determined at baseline. Autologous blood obtained from peripheral vein will be used to prepare PRP following standard protocols and will be injected to both ovaries. Ovarian reserve parameters and ICSI outcomes will be determined.
详细描述
Reproductive age women diagnosed with POR based on Bologna criteria with a history of at least two prior failed intracytoplasmic sperm injection (ICSI) cycle will recruited for the study. Antral follicle count (AFC), serum anti-mullerian hormone (AMH), and early follicular phase serum follicle stimulating hormone (FSH) levels will be determined at baseline. Autologous blood obtained from peripheral vein will be used to prepare PRP following standard protocols. PRP injection will be performed under sedation anesthesia, using a 11.8 inch (30 cm) single lumen 21G needles under transvaginal ultrasound guidance. On the 2 to 4th days of the first three menstrual cycles following the procedure, AFC, AMH, and FSH levels will be re-assessed. Patients with at least one antral follicle will be started on ovarian stimulation for ICSI, followed by embryo transfer. Biomarkers of ovarian reserve (AFC, FSH, AMH), and ICSI outcome parameters (number of metaphase II (MII) oocytes, blastocyst embryos, fertilization rate, oocyte and embryo quality) will be followed.
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
- 30 Years 至 46 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with POR based on Bologna criteria and with a history of at least two prior failed ICSI cycles
- •A previous assisted reproductive technology cycle with less than 3 oocytes (conventional stimulation protocol) and AFC < 7
- •The same ovarian stimulation protocol before and after the PRP treatment
排除标准
- •Age over 46 years,
- •Body mass index (BMI) ≥ 30 kg/m2,
- •Presence of pregnancy
- •Uncontrolled endocrine disorders (polycystic ovary syndrome and others)
- •Parental genetic and chromosomal disorders,
- •Immunological disorders
- •Cancer diagnostics
结局指标
主要结局
Embryo number
时间窗: 3 months
Number of produced embryos per cycle.
Oocyte number
时间窗: 3 months
Number of Metaphase II oocyte yield.
Oocyte quality
时间窗: 3 months
Oocytes will be classified based on morphological assessment and enumeration of extracytoplasmic anomalies.
Embryo quality
时间窗: 3 months
Morphological evaluation of the cultured embryos will be conducted 120 or 144 hr following sperm injection. Blastocysts scoring will be performed on day 5 or 6 depending on the blastocoel cavity expansion and on the inner cell mass and trophectoderm cells integrity.
Fertilization rate
时间窗: 3 months
Fertilization rate will be calculated as the percentage of transformation of the injected oocytes into two pronuclei.
次要结局
- Serum follicle stimulating hormone (FSH)(3 months)
- Antral follicle count (AFC)(3 months)
- Serum anti-mullerian hormone (AMH)(3 months)