A Randomized Comparison of the Live Birth Rate Between the Progestin-primed Ovarian Stimulation Protocol and the Gonadotrophin Releasing Hormone Antagonist Protocol in Patients Undergoing in Vitro Fertilization
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- live birth rate of the first FET live birth rate of the first FET live birth rate
研究概览
简要总结
A randomized comparison of the live birth rate between the progestin-primed ovarian stimulation protocol and the gonadotrophin releasing hormone antagonist protocol in patients undergoing in vitro fertilization
Research question Does the live birth rate of the progestin-primed ovarian stimulation protocol comparable with the GnRH antagonist protocol for patients undergoing IVF?
Design This is a randomized controlled trial.
Research plan
Population: Infertile women who have medical indication for IVF will be recruited for study if they fulfil the selection criteria.
Intervention: Women will receive oral dydrogesterone 20mg daily from Day 3 till the day of ovulation trigger.
Comparator: Women will receive antagonist (Cetrorelix 0.25mg) once subcutaneously daily from day 6 of ovarian stimulation till the day of the ovulation trigger.
Outcomes: The primary outcome is the live birth rate the first FET.
Ovarian stimulation, egg retrieval, embryos frozen and frozen embryo transfer will be performed according to the standard operating procedures of the centres.
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
- •Antral follicle count (AFC) on day 2-5 of the period≥5
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 which is not surgically treated or endometrial polyp on scanning during ovarian stimulation
研究组 & 干预措施
PPOS group
Ovarian stimulation will use the progestin-primed ovarian stimulation (PPOS) protocol.Women will receive progesterone (oral duphaston 20mg) daily from Day 3 till the day of ovulation trigger.
干预措施: Duphaston (Drug)
Antagonist group
Ovarian stimulation will use the antagonist protocol. Women will receive antagonist (Cetrorelix 0.25mg) once subcutaneously daily from day 6 of ovarian stimulation till the day of the ovulation trigger.
干预措施: Cetrorelix (Drug)
结局指标
主要结局
live birth rate of the first FET live birth rate of the first FET live birth rate
时间窗: a live birth after 22 weeks gestation, through study completion, an average of 1 year
live birth rate of the first FET
次要结局
- implantation rate(number of gestational sacs per embryo transferred at 6 weeks of pregnancy, up to 6 weeks)
- positive hCG level(a blood hCG test is performed 14 days after the FET, up to 14 days)
- ectopic pregnancy rate(ectopic pregnancy during first trimester, up to 12 weeks)
- Serum FSH level(on the day of hCG trigger, an average of 2 days after randomization)
- Serum LH level(on the day of hCG trigger, an average of 2 weeks after randomization)
- oocyte retrieved number(the number of oocyte retrieved, an average of 2 weeks after randomization)
- embryo number(the number of embryo, an average of 3 weeks after randomization)
- rate of obstetric complications(obstetric complications during pregnancy or delivery in an average of 1 year)
- Serum estradiol level(on the day of hCG trigger, an average of 2 weeks after randomization)
- ongoing pregnancy rate(viable pregnancy beyond gestation 12 weeks, up to 12 weeks)
- Serum progesterone level(on the day of hCG trigger, an average of 2 weeks after randomization)
- clinical pregnancy rate(presence of intrauterine gestational sac on ultrasound at 6 weeks of pregnancy, up to 6 weeks)
- miscarriage rate(a clinically recognized pregnancy loss before the 22 weeks of pregnancy, up to 22 weeks)
- birth weight(a live birth after 22 weeks gestation, through study completion, an average of 1 year)
- rate of participants with adverse events(adverse events during COH in an average of 1 month)
- multiple pregnancy rate(multiple pregnancy beyond gestation 12 weeks up to 12 weeks)
- rate of fetal or congenital defects(fetal or congenital defects found during pregnancy or delivery in an average of 1 year)