A Prospective Randomized Clinical Trial to Determine the Efficacy of 24 Chromosome Preimplantation Genetic Diagnosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 334
- 试验地点
- 3
- 主要终点
- Sustained Implantation Rate Per Embryo Transferred
研究概览
简要总结
The purpose of this study is to determine if 24 chromosome preimplantation genetic diagnosis (PGD) increases implantation and delivery rates in couples attempting to conceive through in vitro fertilization (IVF).
详细描述
FISH based PGD techniques have provided little improvement in implantation and delivery rates. We believe that the use of 24 chromosome PGD, as compared to control (no PGD) will show a benefit to patients. This study is a randomized clinical trial that seeks to validate 24 chromosome PGD.
Patients that meet the eligibility criteria will be randomized prior to embryo transfer. In order to be randomized, the patient must have blastulated embryos suitable for biopsy on day 5. Half of the patients will received 24 chromosome PGD and will have 2 PGD normal embryos transferred. Half the the patients will receive no PGD and the 2 morphologically best embryos will be transferred. Follow up on pregnant patients will be a blood draw at approximately 9 weeks gestation and buccal swabs collected from the infant(s).
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
- 21 Years 至 43 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age of female partner of < 43 years
- •Normal day-three FSH level (< 15 mIU/mL)
- •Normal uterine cavity
- •Sufficient ejaculated spermatozoa in male partner for ART
- •Maximum of one prior failed IVF cycle
排除标准
- •FSH level ≥ 15 mIU/mL
- •BMI greater than 32 kg/m2
- •Contraindication to gonadotropin stimulation
- •Unevaluated Ovarian mass
- •Need for surgical sperm removal
- •Any contraindication to undergoing in vitro fertilization
- •Age greater than 43 years
- •Presence of hydrosalpinges which communicate with the endometrial cavity
- •Clinical indication for PGD (undergoing IVF with PGD to rule out a known genetic defect)
结局指标
主要结局
Sustained Implantation Rate Per Embryo Transferred
时间窗: Within 1 year
Implantation rate per embryo transferred
次要结局
- Clinical Pregnancy Rate and Delivery Rate per Treatment Cycle(Within 1 Year)