NCT03670407Unknown不适用
Follicular Activation by Fragmentation of Ovarian Tissue
Podobnik Maternity and Gynecology Hospital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2018年9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
- 40
- 试验地点
- 1
- 主要终点
- Antral follicle count
研究概览
简要总结
The primary objective of this study is to assess the chances of increasing the number of antral follicles in ovarian tissue of patients with diminished ovarian reserve by activation of primordial follicles through ovarian cortex fragmentation. 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
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •previous ≥ 2 poor ovarian responds (≤ 3 retrieved oocytes) in an antagonist cycle with a minimum of 225 IU gonadotropins a day or corifollitropin 150 mcg) in patients >35 i <40 years
- •previous cycle with ≤ 3 retrieved oocytes) in an antagonist cycle with a minimum of 225 IU gonadotropins a day or corifollitropin 150 mcg) in patients >35 i <40 years with antral follicle count (AFC) ≤ 5 i/ili antiM¸ulelrian hormone (AMH) ≤ 6.5pmol/L
- •premature ovarian insufficiency according to European Society of Human Reproduction and Embryology (ESHRE) development group, 2015 in patients 18-40 years
- •undetectable AMH serum levels and follitropin (FSH) >35 IU/ml in two serum samples separated by at least 4 weeks
排除标准
- •clinical/ultrasonographical signs of endometriosis
- •previous ovarian/pelvic surgery
- •previous gonadotoxic treatment
- •genito-urinary tract malformations
- •extreme male infertility ( <10 000 progressively motile sperms in the semen sample)
- •inform consent unsigned -
结局指标
主要结局
Antral follicle count
时间窗: 6 months
次要结局
- The number of oocytes retrieved(1 year)
- Clinical pregnancy rate(1 year)
研究者
Miro Šimun Alebić
Head of human reproduction unit
Podobnik Maternity and Gynecology Hospital
研究点 (1)
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