The Comparison of Mild Stimulation and Controlled Ovarian Stimulation in Poor Ovarian Responders: a Prospective Randomized Study.
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- clinical pregnancy rate
研究概览
简要总结
This is a prospective, randomized clinical trial to compare the efficiency and safety of mild stimulation and controlled ovarian stimulation protocol on the treatment of POR. The randomization is achieved on the basis of a computer-generated randomization list in a 1:1 ratio.
详细描述
500 poor ovarian responders will be equally randomized to two different ovarian stimulation protocol arms,i.e, mild ovarian stimulation(experimental arm) or controlled ovarian stimulation(control arm). In experimental arm, patients will received letrozole 5mg per day from cycle day 3 to 7 and recombinant follicle-stimulating hormone (FSH) 150 international unit (IU) on day 4 and 6. The dose of recombinant FSH is adjusted according to the ovarian response and the gonadotropin-releasing hormone(GnRH)antagonist(Cetrotide) 0.25mg per day is administrated when the estradiol level reaches 200 pg/ml and the serum luteinizing hormone （LH）level rises above 2 times of basal LH level. In control arm,patients will be stimulated with short-acting GnRH agonist long protocol. After complete downregulation is achieved through GnRH-agonist, recombinant FSH 300 IU/d is given for 5 days, then the dose of recombinant FSH is adjusted according to ovarian response.
The clinical and ongoing pregnancy rate and other secondary outcome parameters are compared between these two groups.
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
- 20 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •a. Poor ovarian responders b. Normal BMI (18-25 Kg/m2) c. Regular menstruation (with cycle 23-35 days)
排除标准
- •a. History of repeated IVF failure (previous IVF cycle >2) b. Serious adenomyosis c. Polycystic ovary syndrome(PCOS) patients d. History of allergic to ovulation induction medicines e. Abnormal uterine cavity, i.e, intrauterine adhesion f. Attending other clinical trials in the same period. g. History of systemic disease contradictory to COH or pregnancy.
结局指标
主要结局
clinical pregnancy rate
时间窗: 7 weeks
次要结局
- Total dose of recombinant FSH consumption(3 weeks)
- live birth rate(10 months)
- Number of oocytes retrieved(3 weeks)
- Number of transferrable embryo(3 weeks)
- normal fertilization rate(3 weeks)
- implantation rate(7 weeks)
- ongoing pregnancy rate(3 months)
- length of stimulation(3 weeks)
- serum estradiol level(3 weeks)
- serum LH level(3 weeks)
- serum progesterone level(3 weeks)
- serum FSH level(3 weeks)
- FSH level in follicular fluid(3 weeks)
- LH level in follicular fluid(3 weeks)
- Estradiol level in the follicular fluid(3 weeks)
- progesterone level in follicular fluid(3 weeks)
- testerone level in the follicular fluid(3 weeks)
- anti-müllerian hormone (AMH)level in follicular fluid(3 weeks)
- Ovarian Hyperstimulation Syndrome (OHSS) rate(7 weeks)
研究者
Huang Rui
M.D.
Sun Yat-sen University