Use of a Subcutaneous Catheter for Controlled Ovarian Stimulation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Device feasibility
研究概览
简要总结
Subcutaneous medications are an integral part of controlled ovarian stimulation protocols for in-vitro fertilization (IVF), but daily or twice daily injections are both physically and emotionally burdensome for patients and their partners. This is a feasibility study to evaluate the use of the Neria Guard™ (Unomedical, Convatec) subcutaneous catheter for ovarian stimulation in IVF.
详细描述
Daily or twice daily injections are a standard part of controlled ovarian stimulation for in-vitro fertilization (IVF). These injections are both physically and emotionally burdensome for patients and contribute additional stressors to those already inherent to infertility. Subcutaneous catheters have been demonstrated to be effective for administration of insulin, anticoagulants, and other medications in pediatric patients, and subcutaneous gonadotropin-releasing hormone pumps have also been used in hypothalamic patients. This study aims to assess the feasibility of a subcutaneous catheter in patients undergoing ovarian stimulation for IVF. Primary outcomes will include the incidence of safety and catheter-related issues as well as assessment of patient satisfaction in cycles using the subcutaneous catheter. We will also closely monitor estradiol and follicle-stimulating hormone levels during stimulation to ensure adequate medication administration via the catheter as well as IVF outcomes including mature oocyte yield, embryo maturation, and pregnancy rates.
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 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female between 18 and 45 years of age undergoing controlled ovarian stimulation
排除标准
- 未提供
结局指标
主要结局
Device feasibility
时间窗: During ovarian stimulation (usually 9-12 days)
To measure follicle-stimulating hormone (FSH) and estradiol levels after administration of subcutaneous gonadotropins via the catheter
次要结局
- Adverse effects related to the subcutaneous catheter(During ovarian stimulation (usually 9-12 days))
- Patient satisfaction and acceptability(During ovarian stimulation (usually 9-12 days))
- Number of mature oocytes retrieved(Immediately following ovarian stimulation and oocyte retrieval)
- Embryo blastulation(5-7 days after oocyte retrieval)
- Clinical pregnancy(1-2 weeks following embryo transfer)
研究者
Richard Paulson
Professor
University of Southern California