Minimal Stimulation in a Combined Letrozole Antagonist Protocol Versus Microflare Protocol in Poor Responders Undergoing Invitrofertilization/ Intracytoplasmic Sperm Injection; Randomized Parallel Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 132
- 试验地点
- 2
- 主要终点
- Number of oocytes retrieved
研究概览
简要总结
Comparing two ovarian induction protocols in poor responders in IVF/ICSI cycles
详细描述
The two groups of poor responders are randomized into either; a minimal dose stimulation protocol involving letrozole, recombinant FSH and GnRH antagonist versus a microflare conventional protocol with OCP, GnRH agonist and high dose recombinant FSH, in their IVF/ICSI cycles, primary outcome will be the number of oocytes retrieved.
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
- 30 Years 至 43 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •1- More than 1 year of infertility 2 - Poor ovarian responder according to the Bologna criteria:
- •Advanced maternal age
- •Previous poor ovarian response
- •Abnormal tests of ovarian reserve (AFC < 5-7, AMH <0.5-1.1 ng/ml)
排除标准
- •Age > 43 years
- •baseline FSH >15 mIU/ml
- •Previous ovarian surgery
- •Ovarian endometrioma
- •Uterine anomaly or myoma
- •Any medical disorder
- •Any hormonal disorder eg. hyperprolactinemia
- •BMI > 30 kg/m2
- •Severe male factor
研究组 & 干预措施
Minimal Stimulation Group
Minimal dose stimulation ovarian induction protocol given to poor responders, involving letrozole, low dose recombinant FSH and GnRH antagonist
干预措施: Minimal stimulation protocol (Drug)
Minimal Stimulation Group
Minimal dose stimulation ovarian induction protocol given to poor responders, involving letrozole, low dose recombinant FSH and GnRH antagonist
干预措施: IVF/ICSI cycle (Procedure)
Microflare Group
Microflare ovarian induction protocol given to poor responders, involving OCP, GnRH agonist, high dose recombinant FSH
干预措施: Microflare protocol (Drug)
Microflare Group
Microflare ovarian induction protocol given to poor responders, involving OCP, GnRH agonist, high dose recombinant FSH
干预措施: IVF/ICSI cycle (Procedure)
结局指标
主要结局
Number of oocytes retrieved
时间窗: 10 to 14 days
the number of oocytes collected from each participants in the two groups on the day of ovum pickup
次要结局
- Chemical pregnancy rate(14 days after embryo ransfer)
- Number of embryos transferred(Day 3 after ovum pickup)
- Live birth rate(28 to 40 weeks)
- Number of embryos cryopreserved(Day 3 after ovum pickup)
- Number of fertilized oocytes(2 days)
- Clinical pregnancy rate(5 to 7 weeks after embryo transfer)
- Ongoing pregnancy rate(12 weeks)
- Number of MII oocytes retrieved(10 to 14 days)
- Early miscarriage rate(12 weeks)
研究者
Yasmin Ahmed Bassiouny
Assisstant Professor
Cairo University