A Prospective Series of IVF Cases Utilizing in Vitro Maturation (IVM) With Low Cost Priming, Enhanced Oocyte Recovery, and Delayed Embryo Transfer Using a Subsequent Frozen Embryo Transfer Cycle
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Percentage of treated patients having an ongoing pregnancy
研究概览
简要总结
A protocol was developed to improve pregnancy results after IVM compared to results from studies in the literature. Differences from most published protocols include the use of the Steiner-Tan needle to optimize oocyte environment during oocyte retrieval, use of oral medications and very low doses of FSH, and delayed embryo transfer during subsequent warmed cryo-preserved embryo transfer. Eligible patient have a PCO pattern in their ovaries during transvaginal ultrasound.
详细描述
All participants are candidates for IVF having PCOS or having PCO patterns in their ovaries who wish to undertake IVM for the potential advantages that it holds. All cycles are proceeded by oral contraceptive use for cycle scheduling purposes. Priming is done with oral letrozole with the addition of 25-75 IU daily starting after 2 days of letrozole. HCG is given when several follicle have diameters 8 mm or greater and no follicles have diameters greater than 13 mm. Oocyte retrieval is done approximately 38 hours later. A Steiner-Tan needle is used for oocyte retrieval in a manner that minimizes the amount of time that an oocyte is out of the ovary and not in a controlled laboratory environment. Oocytes are assessed for maturity for up to 48 hours post retrieval. If mature, oocytes are injected with sperm using ICSI. Embryos are grown to blastocysts and all blastocyst are vitrified. Warmed cryo-preserved blastocyst are transferred using routine IVF protocols during a subsequent cycle.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 38 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •PCO pattern with > 25 antral follicles
- •AMH > 3.5
排除标准
- •BMI > 35
- •body morphology making transvaginal retrieval difficult or impossible
- •complicating medical condition making pregnancy or IVF relatively contra-indicated
结局指标
主要结局
Percentage of treated patients having an ongoing pregnancy
时间窗: 10 months post transfer
pregnancy with cardiac activity (by history or observations) after 12 weeks
Percentage of treated patients having a clinical pregnancy
时间窗: 12 weeks post transfer
ultrasound evidence of pregnancy in uterus or tissue evidence of pregnancy
次要结局
- Percentage of patients who have a biochemical pregnancy after therir first transfer(28 days post transfer)
- Percentage of retrieved oocytes which matured per patient(2 days post retrieval)
- Percentage of fertilized oocytes which divided(6 days post retrieval)
- Percentage of fertilized oocytes which became blastocysts per patient(8 days post retrieval)
- Percentage of retrieved oocytes which fertilized per patient(4 days post retrieval)
研究者
Bruce Rose, MD
principal investigator
Brown Fertility