Clinical Use of the Perifollicular Vascularity Assessment in in-Vitro Fertilization Cycles: a Pilot Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 116
- 试验地点
- 1
- 主要终点
- Ongoing pregnancy rate
研究概览
简要总结
On February 2004, a law (n. 40/2004) regulating assisted reproduction techniques (ARTs) was approved in Italy. This law aimed to regulate the treatment of infertility in Italy, contains several restrictions, such as the prohibition to fertilize more than three oocytes and the obligation to transfer simultaneously all embryos obtained. Several evidences showed that the outcome of the in-vitro fertilization (IVF) techniques is strongly correlated with quality of transferred embryos (choosing the right embryos). Furthermore, this prerequisite is actually illegal in Italy, and an optimal oocyte selection can be considered as the only one crucial factor in the determining the outcome of the IVF cycle (choosing the right oocytes). Experimental data have demonstrated that perifollicular blood flow assessment is a good marker of oocyte competence, embryo viability, implantation potential, and subsequent pregnancy rate.
The purpose of this study will be to evaluate in a clinical setting whether the assessment of the perifollicular vascularity is a feasible and useful procedure for the selection of oocytes with the best developmental potential in IVF programs when only a limited number of oocytes can be fertilized.
详细描述
One hundred fourteen women with tubal factor or unexplained infertility undergoing IVF programs in our department will be enrolled in a wild protocol. Successively, the enrolled patients will be divided into two different sub-protocols evaluating the role of the perifollicular vascularity in good- and poor-prognosis patients. The diagnosis will be established by hysterosalpingography and/or laparoscopic dye test and with partner's semen analysis.
All patients will be randomly allocated in two independent groups (experimental and control groups) using a computer-software, and the random allocation sequence will be concealed in closed and dark envelope until the interventions will be assigned.
In the experimental group alone, a power Doppler assessment of perifollicular vascularity will be performed the day of oocyte retrieval (36 h after hCG injection). The vascularity of each ovulatory follicle will be successively studied using an advanced image analysis software and its extension will be graded using a well validated grading system. The periovulatory follicles will be categorized in high-grade (grades 3-4) and low-grade (grades 1-2).
After patient' sedation with IV propofol, oocytes will be retrieved using a 17 G double-lumen aspiration needle with a low pressure and individually cultured marking the test-tube and, successively, the culture plate with a code corresponding to perifollicular vascularity degree. The retrieved oocytes will be washed and the mature oocytes, determined by the presence of a first polar body (metaphase II; MII oocytes), will be classified by an experienced biologist initially blinded to previous perifollicular vascularization. In particular, MII oocytes will be graded into three groups according to the number of anomalies: grade I, oocytes without any anomaly; grade II, oocytes with one anomaly; and grade III, oocytes with at least two anomalies.
The three oocytes with the highest grade will be considered "the best" oocytes to fertilize in the control group, whereas in the experimental group they will be selected integrating morphological and ultrasonographic criteria. In particular, the embryologist will use the ultrasonographic criteria to choice within oocytes with similar morphologic degree.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with tubal factor or unexplained infertility undergoing IVF programs.
排除标准
- •Body mass index (BMI, Kg/m2) <18 and >30
- •Peritoneal factor infertility
- •Polycystic ovaries (PCO)
- •Other organic pelvic diseases
- •Abnormal partner's semen
- •Neoplastic, metabolic, endocrinological, hepatic, and cardiovascular disorders or other concurrent medical illness
- •Abuse of alcohol
- •Current or previous use of hormonal drugs
结局指标
主要结局
Ongoing pregnancy rate
次要结局
- Implantation rate