Influence of PRGF (Plasma Rich in Growth Factors) Puncture in Ovaries With Low Follicular Reserve
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Number of follicles recruited after instability of ovarian growth factors
研究概览
简要总结
Assisted reproduction patients candidates to an IVF/ICSI cycle with low follicular reserve: after at least one cycle of stimulation obtaining 0-4 oocytes.
Improve the follicular response in patients with low response, increasing the number of follicles in subsequent cycles to treatment with growth factors.
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 42 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients must give written consent.
- •To be a healthy woman acting voluntarily, aged 18 to 42 years (both inclusive) at the time of study selection time of selection for the study.
- •Have a BMI ≥ 18 kg/m2 and ≤ 35 kg/m2
- •Patients with low ovarian reserve (AMH <1.1 ng/mL) according to the Bologna criteria.
- •Patients who are going to undergo IVF/ICSI cycle with low follicular response: who after a previous cycle of stimulation have obtained 0-3 or more follicular 0-3 oocytes have been obtained after a previous stimulation cycle; or if 0-3 oocytes are expected to be obtained at the present time (less than 4 follicles).
- •oocytes (less than 4 follicles in the basal ultrasound).
- •To have recent analytical results (haemogram, biochemistry and coagulation); at least 11 months prior to inclusion in the study and a serology, according to clinical practice.
- •Translated with www.DeepL.com/Translator (free version)
排除标准
- 未提供
研究组 & 干预措施
Instillation of growth factors
Patients candidates to an IVF/ICSI cycle with low follicular reserve: after at least one cycle of stimulation obtaining 0-3 oocytes.
干预措施: Growth Factors (Drug)
结局指标
主要结局
Number of follicles recruited after instability of ovarian growth factors
时间窗: two months; Time included in two protocols of ovarian stimulation
o demonstrate an increase of at least 20% in the number of MII oocytes in a cycle after IVF/ICSI treatment with PRGF®-Endoret® compared to previous cycles in low IVF/ICSI patients. IVF/ICSI treatment with PRGF®-Endoret® with respect to previous cycles in low responders. responders
次要结局
- Rates of pregnancy rates(three months after embryo transfer after treatment of growth factors)