NCT04306185Unknown不适用
Ovarian Fragmentation Study (Crespo Medical Team)
Equipo Juana Crespo2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2020年5月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Embryo quality improvement following ovarian fragmentation (Using ASEBIR Embryo Classification, 2015)
研究概览
简要总结
This is a study designed to validate Kawamura´s theory and investigation of activation of primordial follicles through ovarian cortex fragmentation. Our aim is to evaluate embryo quality following this procedure in poor ovarian responders and patients with decreased ovarian reserve. Secondary objectives are to assess potential association with the number of oocytes retrieved and pregnancy rates after IVF.
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 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Abdominal surgery need for fertility cause.
- •Bad embryo quality (>2 cycles with < 1 embryo A-B quality. With:
- •A. Poor ovarian responders (previous ≤ 3 retrieved metaphase II oocytes) in a conventional cycle.
- •B. Decreased ovarian reserve (antral follicle count (AFC) ≤ 5 or antiMullerian hormone (AMH) ≤ 0.5 ng/mL).
- •C.Premature ovarian insufficiency according to:
- •Patients < 40 years old.
- •At least 1 year of amenorrhea.
- •Follitropin serum levels (FSH) >35 IU/ml in two serum samples separated by at least 1 month.
- •Estradiol serum levels (E2) < 20 pg/mL.
排除标准
- •Clinical/ultrasonographical signs of severe endometriosis ( or endometrioma).
- •Age over 45 years (EMC)
- •Previous ovarian/pelvic surgery. Unilateral oophorectomy.
- •Body Mass Index > 30
- •Previous gonadotoxic treatment.
- •Genito-urinary tract malformations.
- •Inform consent unsigned.
结局指标
主要结局
Embryo quality improvement following ovarian fragmentation (Using ASEBIR Embryo Classification, 2015)
时间窗: 1 year
Embryo quality improvement following ovarian cortex fragmentation in poor ovarian responders or patients with premature ovarian insufficency using ASEBIR Classification (2015).
次要结局
- - Clinical pregnancy rate following ovarian cortex fragmentation.(1 year)
- - Number of embryos before and after ovarian cortex fragmentation.(2 months)
- - AntiMullerian hormone (AMH) serum levels before and two months after the procedure.(2 months.)
- - Oocyte number and M-II oocyte (mature oocytes) before and after ovarian cortex fragmentation.(2 months)
- - Follicle growth rate before and after ovarian cortex fragmentation.(2 months.)
研究者
研究点 (2)
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