Evaluation of the Relationship Between Air Bubbles Depth and Pregnancy Rate in ICSI Cycles
试验速览
- 阶段
- 不适用
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- biochemical pregnancy rate
研究概览
简要总结
The aim of this work is to assess the effect of air bubbles localization inside the uterus on embryo transfer outcome in ICSI cycles.
Is there a relationship between embryo transfer outcome and the distance between fundal endometrial surface and air bubbles assessed by trans-abdominal ultrasound?
详细描述
All ET will be performed on day 3 after oocyte retrieval at the blastocyst stage by one operator under trans-abdominal US guidance performed by one physician, without any anesthesia or sedation with moderate bladder filling. Two embryos will be transferred using the same type of catheter which is Labotect embryo transfer catheter. It's a semirigid catheter that's less likely to induce endometrial trauma and uterine contractions.
The tip of the inner catheter will be placed approximately 1.5-2 cm from the fundal endometrial surface.The distance between the fundal endometrial surface and air bubbles will be measured and categorized as:
- Group 1: air bubbles depth <10 mm.
- Group 2: air bubbles depth >10 mm. The primary outcome will be biochemical pregnancy rate based on serum quantitative beta-hCG level at 14 days after ET. Secondary outcome will be clinical pregnancy rate using trans-vaginal US examination at 6 - 8 weeks of amenorrhea to detect the presence of fetal sac & pulsation.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 38 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women in reproductive period (age 18-38 years).
- •Infertility due to bilateral tubal block or unexplained infertility programmed for ICSI.
- •BMI < 25 kg/m².
- •FSH level on cycle day 3 of < 12 mIU/mL
排除标准
- •Previous failed ICSI or IVF attempts.
- •Infertility due to male factors.
- •Presence of an abnormal uterine cavity due to endometrial polyps, myomas distorting the uterine cavity, Mullerian malformations, endometrial synechiae, etc. (assessed by transvaginal US and/or hysterography).
- •Patients with hydrosalpinx or pyosalpinx.
- •Patients undergoing ET after cryopreservation.
- •Patients with blood present on the catheter during the transfer procedure.
- •Patients with difficult transfer or with suspicion of touching the fundus.
- •Poor responders.
结局指标
主要结局
biochemical pregnancy rate
时间窗: 14 days after ET
rate of pregnant females by serum quantitative beta-hCG level at 14 days after ET
次要结局
- clinical pregnancy rate(at 6 - 8 weeks of amenorrhea)
研究者
Hagar Elnashar
obstetrics & gynecology resident - Ministry of health
Ain Shams Maternity Hospital