Follicular Long GnRH Agonist Versus Antagonist Protocol in PCOS Women Undergoing in Vitro Fertilization: a Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,266
- 试验地点
- 1
- 主要终点
- clinical pregnancy rate
研究概览
简要总结
Pituitary down regulation is widely used during in vitro fertilization (IVF) procedures. It can suppress the spontaneous luteinizing hormone (LH) surge, and can also make follicles growth evenly.
At present, standard gonadotropin releasing hormone analogue (GnRH-a) long protocol is used in arou Long term GnRH-a, which is usually used in patients with endometriosis,has been shown to increase IVF outcome by altering endometrial receptivity. Moreover, it is also very convenient because patients do not have to inject GnRH-a daily. In order to make patients feel more comfortable during IVF treatment, the investigators have used a new ovarian stimulation protocol since the beginning of 2015. The investigators give patients long term GnRH-a (3.75mg) once at menstrual cycle D2, and begin the use of Gn to stimulate follicle growth around 30 days later based on the hormone levels and follicle size. In the pilot observational study of several patients, no LH surge occurred during ovarian stimulation.
The aim of this randomized controlled study is to compare the efficiency of this new protocol and standard GnRH-a long protocol in the investigator's center.
详细描述
The primary outcome is clinical prengancy rate. Secondary outcome is cumulative live birth rate. Other parameters include number of oocytes retrieved, 2 pronucleus (2PN) fertilization rate, high quality embryo formation rate, implantation rate, spontaneous abortion rate, and ectopic pregnancy rate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 22 Years 至 38 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •First IVF cycle;
- •With normal ovarian reserve(FSH < 10 mIU/mL; antral follicle count>5);
- •With normal uterine.
- •PCOS women according to Rotterdam criteria
排除标准
- •Pre-implantation genetic diagnosis cycles;
- •Oocyte donation or sperm donation cycles.
研究组 & 干预措施
New protocol group
Use long term GnRH-a 3.75mg at day 2 of menstrual cycle. Around 30 days later, controlled ovarian hyperstimulation using gonadotropins is initiated.
干预措施: GnRH-a (Drug)
GnRH-antagonist
In the GnRH antagonist protocol, Gn was injected from day 2-3 of the menstrual cycle and GnRH antagonist (Cetrotide; 0.25 mg) was added daily from day 6 of stimulation. When 2 dominant follicle ≥ 18 mm or three follicles ≥ 17 mm, recombinant human chorionic gonadotropin (hCG) was injected.
干预措施: GnRH-anta (Drug)
结局指标
主要结局
clinical pregnancy rate
时间窗: 5 weeks after embryo transfer
5 weeks after embryo transfer, gestational sac with fetal heart present inside uterus
次要结局
- cumulative live birth rate(2 years after oocyte retrivial)
- Number of oocytes retrieved(1 day at oocyte retrieved day)
- 2 pronucleus (2PN) fertilization rate(48 hours after oocyte retrieved day)
研究者
Yingpu Sun
Director of Reproductive Medical Center, 1st Affilated Hospital, Zhengzhou University
The First Affiliated Hospital of Zhengzhou University