Can Fresh Embryo Transfers be Replaced by Cryopreserved-thawed Embryo Transfers in Assisted Reproductive Cycles?
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- implantation rate
研究概览
简要总结
Cryopreservation of all embryos and transferring them subsequently in assisted reproductive technology (ART) cycles to improve outcome.
详细描述
All patients in the initial cohort were treated with long protocol for ovarian stimulation. For pituitary down-regulation, patients were treated with daily administration of 0.5 mg buserelin (suprefact, Aventis, Frankfurt, Germany) from day 21 of menstrual cycle. Buserelin was reduced to 0.25 mg daily when ovaries were quiescent on ultrasound, and COH was initiated with recombinant FSH (Gonal F, Serono, Aubnne, Switzerland) 150 IU/day on day 2 of withdrawal bleeding. Serial ultrasound examinations and evaluation of serum E2 levels were used to assess ovarian response, and then gonadotropin dose adjustments were done as required. Human chorionic gonadotropin (pregnyl, Organon, Oss, the Netherlands ) 10,000 IU was administered when at least two follicles reached a mean diameter of 18 mm.
Oocyte retrieval was performed 34-36 hours after hCG administration and conventional insemination or ICSI was performed as clinically appropriate.
In 187 patients allocated to fresh ET group, ET were performed on the day 2. Embryos were transferred under ultrasound guidance, with a C.C.D. embryo transfer catheter (Laboratory C.C.D., Paris, France). Luteal support with progesterone in oil (Progesterone, Aburaihan Co., Tehran, Iran) 100 mg daily IM was started on the day of oocyte retrieval and continued until the documentation of fetal heart activity on ultrasound.
In 187 patients allocated to FET group, cryopreservation of all embryos were undertaken with vitrification by Cryotop method and after two months, embryos were transferred.
The protocol for the Cryotop vitrification of embryos was described previously (Kuwayama et al., 2005; Kuwayama, 2007).
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 38 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •age < 38
- •normal day 3 FSH
- •classified as high risk for OHSS
- •has ≥ 15 follicles with a mean diameter ≥ 12 mm per each ovary
- •E2 levels on the day of hCG administration > 3000 pg/mL
- •undergoing her first assisted reproduction treatment cycle
排除标准
- •who does not have good-quality embryos appropriate for cryopreservation
研究组 & 干预措施
frozen-embryo transfer
In this group all embryos are cryopreserved and two months later embryo transfer will perform.
干预措施: freezing embryos by vitrification (Procedure)
frozen-embryo transfer
In this group all embryos are cryopreserved and two months later embryo transfer will perform.
干预措施: buserelin (Drug)
frozen-embryo transfer
In this group all embryos are cryopreserved and two months later embryo transfer will perform.
干预措施: recombinant FSH (Drug)
frozen-embryo transfer
In this group all embryos are cryopreserved and two months later embryo transfer will perform.
干预措施: human chorionic gonadotropin (pregnyl) (Drug)
fresh embryo transfer
In this arm fresh embryo transfers are performed on day 2 or 3.
干预措施: fresh embryo transfers (Procedure)
fresh embryo transfer
In this arm fresh embryo transfers are performed on day 2 or 3.
干预措施: buserelin (Drug)
fresh embryo transfer
In this arm fresh embryo transfers are performed on day 2 or 3.
干预措施: recombinant FSH (Drug)
fresh embryo transfer
In this arm fresh embryo transfers are performed on day 2 or 3.
干预措施: human chorionic gonadotropin (pregnyl) (Drug)
结局指标
主要结局
implantation rate
时间窗: 4 weeks
次要结局
- on going pregnancy rate(3 months)