Comparison of Transfers of Fresh and Thawed Embryos in Normal Responder Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Clinical pregnancy (fetal heartbeat observed on ultrasound at 7 weeks gestation)
研究概览
简要总结
This study tests the hypothesis that controlled ovarian stimulation impairs endometrial receptivity in normal responders.
详细描述
The purpose of this study is to determine if blastocyst transfers in cycles of post-thaw extended culture (PTEC) have different efficacy than transfers of fresh blastocysts in patients with expected normal response to ovarian stimulation.
Multiple studies have found altered endometrial histology and gene expression following controlled ovarian stimulation.
PTEC cycles require cryopreservation of the entire 2pn oocyte cohort in the prior cycle. Once thawed, the embryos are cultured to the blastocyst stage before transfer.
In typical cycles using frozen-thawed embryos, many thawed embryos that appear to survive do not actually resume and continue development. PTEC ensures the transfer of embryos that resumed development and continued developing at least to the blastocyst stage (4-5 days post-thaw).
The viability of a blastocyst in a PTEC cycle has been shown to be on par with that of a fresh blastocyst. Therefore, comparing outcomes of blastocyst transfers in PTEC cycles with that in fresh autologous cycles allows the potential endometrial impact of controlled ovarian stimulation to be assessed.
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 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female patient 18 to 40 years of age seeking their first IVF treatment.
- •Cycle day 3 FSH less than 10.0 IU/l.
- •8 to 15 antral follicles observed on ultrasound.
排除标准
- •Failure to follow the protocol.
- •Embryo biopsy.
- •Any prior IVF cycle(s).
结局指标
主要结局
Clinical pregnancy (fetal heartbeat observed on ultrasound at 7 weeks gestation)
时间窗: 7 weeks gestation
次要结局
- Ongoing pregnancy at 10 weeks gestation(10 weeks gestation)
- Implantation rate (ratio of the number of fetal heart tones to the number of transferred blastocysts)(7 weeks gestation)