Experience of Pain During Oocyte Retrieval- a Comparison Between Two Aspiration Needles
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Vitrolife
- 入组人数
- 257
- 试验地点
- 4
- 主要终点
- Visual Analogue Scale
研究概览
简要总结
The purpose of the study is to compare the pain experience between the patients that have had their transvaginal oocytes retrieval with ultrasound guidance performed with reduced single lumen needle (Vitrolife Sweden AB, Gothenburg) with the patients that have had follicle aspiration needle, 1.4 outer diameter (Vitrolife Sweden AB, Gothenburg), during the procedure.
详细描述
Although the patient is sedated and local analgesia has been given, transvaginal oocytes retrieval with ultrasound guidance can still cause a lot of pain, both during and after the procedure. To reduce the pain, some clinics prefer to use needles as thin as 0.8 mm (outer diameter, OD). A disadvantage with these needles is the increased aspiration time. Therefore a new needle has been developed that has the possibility to reduce pain without a large increase in aspiration time. The needle has a 50 mm long tip with an outer diameter of 0.9 mm. The remaining part of the needle is 300 mm long with an outer diameter of 1.4 mm.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •The patient has signed an informed consent form before the oocyte retrieval
- •The patient is undergoing oocyte retrieval with local anaesthesia
- •The patient can speak and understand Swedish
排除标准
- •The patient has previously participated in Vitrolife-needle-01 study
- •The patient has a body mass index ≥35
- •Other contra indicator for oocyte retrieval
研究组 & 干预措施
Thin Follicle Aspiration Needle
Transvaginal oocyte retrieval was performed under local anaesthesia and under guidance of ultrasound with the RN needle that had an outer diameter of 0.9 mm (20 gauge) and inner diameter of 0.6 mm for the last 50 mm from the tip of the needle and an outer diameter of 1.4 mm (17 gauge) and inner diameter of 1 mm for the remaining length of the needle. The puncture procedure was performed according to each clinic's standard routine. Aspiration pressure was kept at a negative pressure between 90 and 120 mmHg.
干预措施: Swemed Follicle Aspiration Set Reduced Single Lumen (Device)
Standard Follicle Aspiration Needle
Transvaginal oocyte retrieval was performed under local anaesthesia and under guidance of ultrasound with the SN needle that had an outer diameter of 1.4 mm (17 gauge) and inner diameter of 1 mm for the remaining length of the needle. or the SN with an outer diameter of 1.4 mm (17 gauge) and inner diameter of 1 mm for the whole length of the needle.
The puncture procedure was performed according to each clinic's standard routine. Aspiration pressure was kept at a negative pressure between 90 and 120 mmHg.
干预措施: Swemed Follicle Aspiration Set Single Lumen (1.4 mm) (Device)
结局指标
主要结局
Visual Analogue Scale
时间窗: After the oocyte retrieval and before the patient leaves the operation room e.g. within a maximum of 30 minutes.
Rating of pain was performed by self-assessment by means of Visual Analogue Scale (VAS) consisting of a line oriented vertically on a paper with a range from 0 mm (no pain) to 100 mm (unbearable pain).
次要结局
- Intervention Because of Bleeding(During and directly after oocyte retrieval)