Comparison of 5 Day Embryo Transfer With 2-3 Day Transfer in Patients Who Failed to Conceive in Two or More Day 2-3 Embryo Transfer Cycle in Royan Institute
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Live birth rate
研究概览
简要总结
The purpose of this study is to determine whether embryo transfer on day 3 versus day 5 shows a significant difference in implantation, clinical pregnancy, live birth, miscarriage and multiple pregnancy rates among women with at least two previous IVF failures
详细描述
A total of 200 infertile women with at least two previous IVF failures will enroll in this prospective randomized clinical trial study and will randomly be divided into two groups. Random permuted blocks with a block size of 4 will be used to ensure randomization and complete allocation concealment.
The study protocol will be assessed by an independent institutional review board and Royan ethics committee.
Ovarian stimulation protocol will include the use of a GnRH agonist (Superfact; Aventis Pharma Deutshlan, Frankfurt, Germany) administered in the long (down-regulation) protocol and the subsequent addition of FSH (Gonal F, Sereno, Switzerland). Embryos will be initially cultured in G1.V5 medium) Vitrolife-Sweden)TM on day 1 and 2, being transferred from this medium to G2.V5 ) Vitrolife-Sweden)TM on day 3. Embryos will be transferred on day 5, depending on the degree of expansion of the blastocyst.
Main outcome measures will be implantation, clinical pregnancy and live birth rates.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •Age fewer than 40
- •Normal uterine cavity and patent tubes by either hysterosalpingogram or laparoscopy and hysteroscopy
- •Two previous or more failed IVF/ICSI cycles
排除标准
- •Women with submucous myoma
- •Women with intra mural or subserous myoma greater than 3 cm
- •Women with Endometriosis or Endometrioma
- •Hydrosalpinx
研究组 & 干预措施
Day 5 embryo transfer group
Embryo will transfer at blastocyst stage (day 5 after ovum pick up)
干预措施: Day 5 embryo transfer group (Procedure)
结局指标
主要结局
Live birth rate
时间窗: After 37 weeks of gestational age
Clinical Pregnancy rate
时间窗: 6-8 weeks after oocyte retrieval
次要结局
- Miscarriage rate(18 weeks after fertilization)
- Implantation rate(4 weeks after embryo transfer)