A Randomized, Controlled, Open Trial Comparing a 17 G Single Lumen Aspiration Needle With a Modified Double Lumen Needle System (STEINER-TAN Needle®) for Follicular Flushing During Oocyte Pick-up in IVF Patients 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
- 80
- 试验地点
- 2
- 主要终点
- Mean number of COSs per patient randomized.
研究概览
简要总结
The primary objective is to demonstrate superiority of follicle flushing with the STEINER-TAN Needle® as compared to single lumen aspiration in terms of numbers of COCs retrieved.
详细描述
Rationale:
Since the number of oocytes available for IVF is a determinant of the cumulative chance of a patient to achieve pregnancy, it is of paramount importance to optimize the number of oocytes at oocyte pick-up. This especially for a fraction of patients, who despite high-dosed FSH stimulation, produce only a small number of growing follicles (poor response).
Objective:
The primary objective is to demonstrate superiority of follicle flushing with the STEINER-TAN Needle® as compared to single lumen aspiration in terms of numbers of COCs retrieved.
The secondary objective is to study differences in numbers of mature oocytes, proportion of patients undergoing embryo transfer, pregnancy rate, duration of the procedure, impact on patient burden (as assessed by the DASS 21, the German pain questionnaire [www.dgss.org\]) and subjective patient experience.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female subjects undergoing IVF or ICSI treatment with or without ovarian stimulation
- •≤ 5 follicles >10 mm at the end of the follicular phase as assessed by transvaginal ultrasound
- •Presence of two ovaries
- •Willingness to participate
- •Informed consent
排除标准
- •BMI <18 or >35 kg/m2
- •Ovaries cannot be reached (e.g. heterotopic ovaries)
- •Age <18 or >45
结局指标
主要结局
Mean number of COSs per patient randomized.
时间窗: 1 day
次要结局
- Mean DASS 21 score after the procedure(1 day)
- Mean number of fertilized (2PN) oocytes(2 days)
- Mean number of mature metaphase II oocytes(1 day)
- Pregnancy rate(7 weeks)
- Mean duration of the procedure.(1 day)
研究者
Prof. Dr. med. M.Sc. Georg Griesinger
Prof. Dr. med. M.Sc. Georg Griesinger
University of Luebeck