A Randomized Control Trial to Compare the Live Birth Rate Between the Progestin-primed Ovarian Stimulation Protocol and the GnRH Antagonist Protocol in Patients With Anticipated High Ovarian Response Undergoing IVF
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 784
- 试验地点
- 1
- 主要终点
- live birth rate
研究概览
简要总结
Progestin can inhibit the pituitary LH surge during ovarian stimulation and various studies show progestin-primed ovarian stimulation (PPOS) is effective in blocking the LH surge in IVF. More and more centers in China are using PPOS because this regimen appears simpler and cheaper.A randomized trial to compare the effectiveness of PPOS and GnRH antagonist protocol in IVF in terms of the live birth rate is urgently needed.
Trial objectives: To compare the live birth rate between the PPOS protocol and the antagonist protocol used for ovarian stimulation during IVF
Eligible women will be randomised into one of the two groups:
Antagonist group : Women will receive antagonist (Cetrorelix or Ganirelix 0.25mg) once subcutaneously daily from day 6 of ovarian stimulation till the day of the ovulation trigger.
PPOS group: Women will receive oral medroxyprogesterone 10 mg daily or duphaston 10mg bd daily from Day 3 till the day of ovulation trigger.
There will be no fresh transfer. Only one blastocyst will be allowed to replaced in the first FET and a maximum of two blastocysts will be replaced in the subsequent FET cycles.
The primary outcome is the live birth rate of the first frozen-thawed transfer cycle.
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 43 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age of women <43 years at the time of ovarian stimulation for IVF
- •The first IVF cycle
- •Antral follicle count (AFC) >15 on day 2-5 of the period
排除标准
- •Presence of a functional ovarian cyst with E2>100 pg/mL
- •Recipient of oocyte donation
- •Undergoing preimplantation genetic testing
- •Presence of hydrosalpinx or endometrial polyp which is not surgically treated
研究组 & 干预措施
Antagonist group
Women will receive antagonist (Cetrorelix or Ganirelix 0.25mg) once subcutaneously daily from day 6 of ovarian stimulation till the day of the ovulation trigger.
干预措施: GnRH Antagonist (Drug)
PPOS group
Women will receive oral medroxyprogesterone 10 mg daily or duphaston 10mg bd daily from Day 3 till the day of ovulation trigger.
干预措施: Progesterone (Drug)
结局指标
主要结局
live birth rate
时间窗: deliveries ≥22 weeks gestation with heartbeat and breath
live birth rate of the first frozen embryo transfer cycle
次要结局
- implantation rate(6 weeks' gestation)
- progesterone level on the trigger day(2 days before oocyte retrieval)
- estradiol and progesterone levels in the follicular fluid(1 year after FET)
- ongoing pregnancy(12 weeks' gestation)
- cumulative live birth(2 years' after FET)
- number of oocytes retrieved(1 day after oocyte retrieval)
- number and grading of blastocysts(1 week after oocyte retrieval)
- multiple pregnancy(multiple pregnancy beyond gestation 12 weeks)
- serum baseline FSH(day 2-3 of period)
- ectopic pregnancy(ectopic pregnancy during 12 weeks gestation)
- estradiol level on the trigger day(2 days before oocyte retrieval)
- positive serum hCG(2 weeks after FET)
- clinical pregnancy(6 weeks' gestation)
- biochemical pregnancy(6 weeks' gestation)
- birthweight of newborns(1 year after FET)
- miscarriage(22 weeks of pregnancy)