The Effectiveness of a Freeze All Protocol Versus Fresh Embryo Transfer in Women Undergoing In-vitro Fertilization (IVF) - Intracytoplasmic Sperm Injection (ICSI)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 782
- 试验地点
- 1
- 主要终点
- Ongoing pregnancy
研究概览
简要总结
To compare the effectiveness of freeze-all and subsequent frozen embryo transfer (freeze all protocol) with fresh embryo transfer (fresh ET).
详细描述
All patients undergoing in-vitro fertilization (IVF) will be treated with GnRH antagonist protocol. Recombinant Follicle-stimulating hormone (FSH) will be given on day 2 or day 3 of menstrual cycle for 5 days. The starting dose is individualized for each patient based on the following criteria: Anti-Mullerian Hormone (AMH) < 0.7 ng/ml, dose 300 IU/day, AMH 0.7 -2.1 ng/ml, dose 225 IU/day, AMH > 2.1 ng/ml, dose 150 IU/day. After that, investigators can titrate the dose based on their clinical judgment. Follicular development will be monitored by ultrasound scanning and measurement of estradiol, progesterone starting on day 5 of stimulation. Scanning and hormonal measurement will be repeated every 2 to 3 days, depending on the size of follicles. Antagonist is routinely used on day 5 until the day of Human chorionic gonadotropin (hCG). Criteria for recombinant hCG (6,500 IU) administration is the presence of at least three leading follicles of 17 mm. Oocyte retrieval is performed 36 hours after recombinant hCG administration.
We will measure progesterone levels during stimulation on the day 5 and day 7, as well as on the day of oocyte triggering.
Insemination will be performed by using intracytoplasmic sperm injection, 3 - 4 hours after oocyte retrieval. Only matured oocytes are inseminated. Fertilization are performed under inverted microscope at period of 16-18 hours after insemination.
On day 3, endometrium thickness will be measured and embryo evaluation will be performed at fixed time point 68±1 hours after fertilization, using Istanbul consensus. After grading embryo, eligible patients will be invited to participate in the study. Written consent will be obtained from each patient for participation into the study. Patients will be randomized into 2 groups fresh embryo transfer and freeze-all. Randomization will be done by third party via telephone, using a computer-generated random list, with block size of 2, 4, 8.
Study Procedures
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 42 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Undergoing In-vitro fertilization (IVF) treatment
- •Number of previous failed embryo transfers ≤ 2
- •Permanent living in Viet Nam
- •Ovarian hyperstimulation with Gonadotropin releasing hormone (GnRH) antagonist protocol
- •Eligible for embryo transfer (ET) on day 3
- •Having at least one top-quality embryo on day
- •Number of embryos transferred ≤ 2
- •Willing to participate in the study
- •Not to participate in another IVF study at the same time
排除标准
- •women with polycystic ovary syndrome
- •In vitro maturation (IVM) cycles
- •Oocyte donation cycles
- •Using GnRH agonist for triggering
结局指标
主要结局
Ongoing pregnancy
时间窗: 12 weeks of gestation
Ongoing pregnancy is defined as a pregnancy with at least one positive heart beat beyond 12 weeks of gestation.
次要结局
- Implantation rate(3 weeks after embryo transferred)
- Live birth(at the time of delivery)
- Clinical pregnancy(5 weeks after embryo placement)
- Multiple pregnancy rate(5 weeks after embryo placement)
研究者
Manh Tuong Ho
Doctor
Vietnam National University