Follicular Flushing on Cycle Outcomes in Poor Responders
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- FOLLICULAR FLUSHING ON CYCLE OUTCOMES IN POOR RESPONDERS
研究概览
简要总结
Patients with infertility often undergo in vitro fertilization (IVF) to achieve a pregnancy, which involves ovarian stimulation, monitoring of follicular growth, oocyte retrieval, sperm insemination, embryo culture and embryo transfer.
The oocytes are removed during surgery by aspirating the follicles using a single lumen needle with an ultrasound to guide the procedure. There is some data that flushing the follicles with embryo culture media before aspiration using a double lumen needle increases the number of oocytes retrieved, particularly among poor responding patients for whom each additional oocyte recovered may substantially alter the outcome of that IVF cycle.
The objective of the research is to evaluate the effect of follicular flushing in poor responders on IVF cycle outcomes.
详细描述
Patients with infertility often undergo in vitro fertilization (IVF) to achieve a pregnancy, which involves ovarian stimulation, monitoring of follicular growth, oocyte retrieval, sperm insemination, embryo culture and embryo transfer. The number of embryos obtained is dependent on the number of oocytes retrieved.
The objective of the research is to evaluate the effect of follicular flushing in poor responders on IVF cycle outcomes, including the number of oocytes retrieved, number of mature oocytes, fertilization rate, number of embryos transferred, implantation rate, miscarriage rate, live birth rate, operating room time, and luteal estradiol and progesterone levels.
The research entails a prospective, randomized, controlled trial of poor-responder patients who are undergoing IVF treatment at The Ronald O. Perelman and Claudia Cohen Center for Reproductive Medicine, defined as patients who have ≤ 4 follicles that are ≥ 12mm on the day of hCG trigger.
Patients identified as poor responders will be consented and randomized to follicular flushing versus aspiration without flushing. A 2-5mL flush using embryo culture media followed by aspiration of the follicle will be performed in the patients randomized to the flushing group, with subsequent flushes until an oocyte is identified or up to 4 flushes maximum.
Patients being enrolled in this research study will undergo IVF regardless of participation in this research study.
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
- •Pts ages 18-45 undergoing IVF
- •Pts with ≤ 4 follicles that are ≥ 12mm on day of HCG
排除标准
- •Pts undergoing natural cycles (i.e. those with intentionally low # of follicles)
研究组 & 干预措施
Follicular flushing
Flushing follicles with embryo culture media prior to aspiration.
干预措施: Aspiration without flushing follicles with culture media (Other)
Follicular flushing
Flushing follicles with embryo culture media prior to aspiration.
干预措施: Follicular Flushing (Other)
结局指标
主要结局
FOLLICULAR FLUSHING ON CYCLE OUTCOMES IN POOR RESPONDERS
时间窗: 2 weeks
To evaluate the number of oocytes retrieved with follicular flushing in poor responders
次要结局
- FOLLICULAR FLUSHING ON CYCLE OUTCOMES IN POOR RESPONDERS(2 weeks)