Oocyte Recovery Rate Following Follicular Flushing Versus Direct Aspiration in Women Undergoing IVF
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Oocyte recovery rate
研究概览
简要总结
The purpose of this study is to investigate the impact of follicular flushing on the oocyte recovery rate, oocyte maturity, fertilization rate, and embryo development and utilization as compared to direct aspiration (no flushing) in women undergoing IVF treatment
详细描述
This will be a prospective observational paired study on the effect of follicular flushing oocyte recovery rate, oocyte maturity, fertilization rate, and embryo development and utilization as compared to direct aspiration (no flushing) in women undergoing IVF treatment.
In each woman enrolled, one ovary (right or left) will be randomly assigned to be aspirated with either follicular flushing or direct aspiration without flushing. The primary endpoint will be oocyte recovery rate (oocytes retrieved per follicle aspirated). Secondary outcomes will be oocyte maturity, fertilization rate, and embryo development and utilization. Pregnancy rates will be reported as a surrogate outcome.
TRANSVAGINAL OOCYTE COLLECTION
Following controlled ovarian stimulation (COS), final oocyte maturation is triggered using hCG or triptorelin. Oocyte collection is performed 35-36 hours post triggering. The procedure involves transvaginal ultradound-guided aspiration of follicles via a double lumen aspiration needle (16G, Casmed),. An interdisciplinary team is required for the procedure, including Gynaecologists, Embryologists Midwives/Nurses and Anaesthetists. It is performed in a gynaecological operating theatre, adjacent to an embryology laboratory, with the patient being sedated and under aseptic conditions and strict regulation of environmental conditions to ensure oocyte viability and patient safety.
Before the procedure The day before the procedure, the embryologist prepares culture dishes (Falcon Central Well dishes) containing bicarbonate buffered media specifically designed for oocyte culture (Fert, Origio) overlaid with mineral oil (Fertipro). The dishes are placed in a 5-7% CO2 incubator at 37oC to equilibrate overnight. Aliquots of HEPES buffered media (Flushing medium, Origio) which achieves pH regulation outside of the incubator is pre-heated to 37oC. Finally, 160 ml flasks of DPBS (phosphate buffered saline) for use in follicular flushing are placed in the theatre's incubator for pre-warming. All the embryological preparation is performed aseptically under a laminar flow hood.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Presence of both ovaries
- •18-40 years old
- •Triggering final oocyte maturation using human chorionic gonadotrophin (hCG) or gonadotrophin releasing hormone (GnRH) agonist
排除标准
- •One or no ovaries present
- •Endometriosis
- •Previous history of hemorrhage during oocyte retrieval
结局指标
主要结局
Oocyte recovery rate
时间窗: Day of oocyte retrieval
Number of oocytes retrieved per follicle aspirated
次要结局
- Blastocyst formation rates(Day 5 post oocyte retrieval)
- Embryo utilization(Day 5 post oocyte retrieval)
- Oocyte maturation rate(Day of oocyte retrieval)
- Fertilization rate(Day 1 post oocyte retrieval)
- Hemorrhage(Day of oocyte retrieval)
- Number of oocytes retrieved(Day of oocyte retrieval)
- Embryo cryopreservation(Day 5 post oocyte retrieval)
- Good quality embryos on day 2/3(2/3 days post oocyte retrieval)
- Embryos transferred(Days 2-5 post oocyte retrieval)